Inguinal Hernia
Conditions
Keywords
Infants, scheduled, unilateral, bilateral, repair
Brief summary
The primary purpose of the GAS study is to determine whether different types of anesthesia (Regional versus General) given to 720 infants undergoing inguinal hernia repair results in equivalent neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.
Detailed description
This is a prospective, observer blind, multi-site, randomized, controlled, equivalence trial. The general anesthesia group will receive sevoflurane (intervention drug) for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg per kg) administered via caudal or ilioinguinal nerve block. The airway can be maintained with a face mask, laryngeal mask or endotracheal tube, with or without neuromuscular blocking agents. The regional group will have no sedative agent. The regional blockade may be with spinal alone, spinal block with caudal block, spinal with ilioinguinal block or caudal alone. The maximum dose of 2.5 mg per kg of bupivacaine can be used.
Interventions
DRUGRegional Anesthesia
Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot.
DRUGGeneral Anesthesia
Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block.
Sponsors
Royal Children's Hospital
Royal Hospital for Sick Children
Murdoch Childrens Research Institute
Food and Drug Administration (FDA)
Boston Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
No minimum to 60 Weeks
Healthy volunteers
No
Inclusion criteria
* Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision) * Any infant whose gestational age is 26 weeks or more (GA = 182 days) * Any infant whose post-menstrual age is up to 60 weeks (PMA = 426 days)
Exclusion criteria
* Any child older than 60 weeks post-menstrual age * Any child born less than 26 weeks gestation * Any contraindication to general or spinal/caudal anesthesia (for example: neuromuscular disorder or coagulopathy) * Pre-operative ventilation immediately prior to surgery * Congenital heart disease that has required ongoing pharmacotherapy * Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development * Children where follow-up would be difficult for geographic or social reasons * Families where English is not the primary language spoken at home * Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular hemorrhage (ICH) (+/- post hemorrhage ventricular dilation) * Previous exposure to volatile anesthesia or benzodiazepines as a neonate or in the third trimester in utero.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Full Scale IQ Score | At 5 years chronological age | The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Performance IQ | At 5 years corrected age | Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates a higher performance IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Processing Speed Quotient | At 5 years corrected age | Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient Minimum possible score:45 Maximum possible score:145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Sentence Repetition Scaled Score | At 5 years chronological age | Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Auditory Attention Combined Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Statue Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Inhibition Combined Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Word Generation Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Affect Recognition Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Memory for Names and Memory for Names Delay | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Theory of Mind Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Speeded Naming Combined Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Fingertip Tapping Repetitions Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score is indicative of a better outcome. |
| Fingertip Tapping Sequences Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Design Copy Process Total Scaled Score | At 5 years corrected age | Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Word Reading Standard Score | At 5 years chronological age | Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score Minimum possible score: 45 Maximum possible score: 145 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a better outcome. |
| Numerical Operations Standard Score | At 5 years chronological age | Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score Minimum possible score: 45 Maximum possible score: 145 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a better outcome. |
| Spelling Standard Score | At 5 years chronological age | Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score Minimum possible score: 45 Maximum possible score: 145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Numbers Total Scaled Score | At 5 years chronological age | Children's Memory Scale (CMS):Numbers Total scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Word Lists 1 (Learning) Scaled Score | At 5 years chronological age | Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
| Verbal IQ | At 5 years corrected age. | Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates higher verbal IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function | At 5 years chronological age | Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities. Minimum possible score: 40 Maximum possible score: 110 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a worse outcome. |
| The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System | At 5 years chronological age | Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System \- 2nd edition (ABAS-II) to measure the child's adaptive behavior. Minimum possible score: 45 Maximum possible score: 145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Total Problems Score | At 5 years chronological age | Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Internalising Problems T Score | At 5 years chronological age | Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Externalising Problems T Score | At 5 years chronological age | Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. |
| Speech or Language Interventions | At 5 years chronological age | Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Psychomotor Interventions | At 5 years chronological age | Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With Global Developmental Delay | At 5 years chronological age | Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With Attention Deficit Hyperactivity Disorder | At 5 years chronological age | Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With Autism Spectrum Disorder | At 5 years chronological age | Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With a Hearing Abnormality | At 5 years chronological age | Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With a Visual Defect in Either Eye | At 5 years chronological age | Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants With a Hearing Aid | At 5 years chronological age | Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants Who Are Legally Blind | At 5 years chronological age | Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Number of Participants Who Have Cerebral Palsy | At 5 years chronological age | Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Parents' Awareness of Group Allocation | At 5 years chronological age | Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Awareness of Group Allocation by Psychologist | At 5 years chronological age | These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated. |
| Awareness of Group Allocation by Pediatrician | At 5 years chronological age | — |
| Memory and Learning Word Lists II (Delayed) Scaled Score | At 5 years chronological age | Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome. |
Countries
Australia, Canada, Italy, Netherlands, New Zealand, United Kingdom, United States
Participant flow
Pre-assignment details
There are no significant events that occur after enrollment and before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Regional Anesthesia Regional Anesthesia: Up to 2.5 mg/kg bupivacaine administered by caudal or subarachnoid routes or both caudal and subarachnoid or subarachnoid and ilioinguinal nerve blockade. Single shot. | 287 |
| General Anesthesia General Anesthesia: Sevoflurane for induction and maintenance of general anesthesia, dose up to 8% inspired for duration of procedure plus bupivacaine local anesthetic blockade (up to 2.5 mg/kg) administered via caudal or ilioinguinal nerve block. | 356 |
| Total | 643 |
Baseline characteristics
| Characteristic | Regional Anesthesia | General Anesthesia | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 287 Participants | 356 Participants | 643 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 68.9 days STANDARD_DEVIATION 30.8 | 71.1 days STANDARD_DEVIATION 31.7 | 70 days |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Australia | 63 participants | 72 participants | 135 participants |
| Region of Enrollment Canada | 10 participants | 20 participants | 30 participants |
| Region of Enrollment Italy | 45 participants | 50 participants | 95 participants |
| Region of Enrollment Netherlands | 19 participants | 17 participants | 36 participants |
| Region of Enrollment New Zealand | 7 participants | 9 participants | 16 participants |
| Region of Enrollment United Kingdom | 27 participants | 22 participants | 49 participants |
| Region of Enrollment United States | 34 participants | 52 participants | 86 participants |
| Sex: Female, Male Female | 55 Participants | 52 Participants | 107 Participants |
| Sex: Female, Male Male | 232 Participants | 304 Participants | 536 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Full Scale IQ Score
The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Full Scale IQ Score | 100.5 score on scale | Standard Deviation 14.3 |
| General Anesthesia | Full Scale IQ Score | 100.1 score on scale | Standard Deviation 15.3 |
Secondary
Affect Recognition Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Affect Recognition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Affect Recognition Scaled Score | 10.6 score on scale | Standard Deviation 2.8 |
| General Anesthesia | Affect Recognition Scaled Score | 10.4 score on scale | Standard Deviation 3.2 |
Secondary
Auditory Attention Combined Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Auditory Attention combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Auditory Attention Combined Scaled Score | 9.0 score on scale | Standard Deviation 2.7 |
| General Anesthesia | Auditory Attention Combined Scaled Score | 9.3 score on scale | Standard Deviation 3 |
Secondary
Awareness of Group Allocation by Pediatrician
Time frame: At 5 years chronological age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Awareness of Group Allocation by Pediatrician | 13 Pediatricians |
| General Anesthesia | Awareness of Group Allocation by Pediatrician | 13 Pediatricians |
Secondary
Awareness of Group Allocation by Psychologist
These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Awareness of Group Allocation by Psychologist | 7 psychologists |
| General Anesthesia | Awareness of Group Allocation by Psychologist | 7 psychologists |
Secondary
Design Copy Process Total Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Design Copy Process Total Scaled Score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Design Copy Process Total Scaled Score | 9.6 score on a scale | Standard Deviation 3.4 |
| General Anesthesia | Design Copy Process Total Scaled Score | 9.9 score on a scale | Standard Deviation 3.1 |
Secondary
Externalising Problems T Score
Child Behaviour Checklist Caregiver Questionnaire (CBCL): externalising problems T score Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Externalising Problems T Score | 44.0 score on scale | Standard Deviation 10.7 |
| General Anesthesia | Externalising Problems T Score | 45.8 score on scale | Standard Deviation 11.9 |
Secondary
Fingertip Tapping Repetitions Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test:Fingertip tapping repetitions scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score is indicative of a better outcome.
Time frame: At 5 years corrected age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Fingertip Tapping Repetitions Scaled Score | 9.8 score on scale | Standard Deviation 3.4 |
| General Anesthesia | Fingertip Tapping Repetitions Scaled Score | 9.7 score on scale | Standard Deviation 3.4 |
Secondary
Fingertip Tapping Sequences Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: fingertip tapping sequences scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Fingertip Tapping Sequences Scaled Score | 8.1 score on scale | Standard Deviation 3.4 |
| General Anesthesia | Fingertip Tapping Sequences Scaled Score | 7.7 score on scale | Standard Deviation 3.6 |
Secondary
Inhibition Combined Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Inhibition combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Inhibition Combined Scaled Score | 8.3 score on scale | Standard Deviation 3.1 |
| General Anesthesia | Inhibition Combined Scaled Score | 8.9 score on scale | Standard Deviation 3 |
Secondary
Internalising Problems T Score
Child Behaviour Checklist Caregiver Questionnaire (CBCL): CBCL internalising problems T score Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Internalising Problems T Score | 46.1 score on scale | Standard Deviation 12.5 |
| General Anesthesia | Internalising Problems T Score | 48.0 score on scale | Standard Deviation 12.5 |
Secondary
Memory and Learning Word Lists II (Delayed) Scaled Score
Children's Memory Scale (CMS): Memory and learning Word Lists II (delayed) scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Memory and Learning Word Lists II (Delayed) Scaled Score | 9.7 score on scale | Standard Deviation 2.8 |
| General Anesthesia | Memory and Learning Word Lists II (Delayed) Scaled Score | 9.6 score on scale | Standard Deviation 2.9 |
Secondary
Memory for Names and Memory for Names Delay
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Memory for Names and Memory for Names Delay Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Memory for Names and Memory for Names Delay | 8.1 score on scale | Standard Deviation 3.2 |
| General Anesthesia | Memory for Names and Memory for Names Delay | 8.1 score on scale | Standard Deviation 3.2 |
Secondary
Number of Participants Who Are Legally Blind
Child is legally blind. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants Who Are Legally Blind | 0 participants |
| General Anesthesia | Number of Participants Who Are Legally Blind | 0 participants |
Secondary
Number of Participants Who Have Cerebral Palsy
Child has cerebral palsy. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants Who Have Cerebral Palsy | 1 participants |
| General Anesthesia | Number of Participants Who Have Cerebral Palsy | 3 participants |
Secondary
Number of Participants With a Hearing Abnormality
Child has a hearing abnormality. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With a Hearing Abnormality | 8 participants |
| General Anesthesia | Number of Participants With a Hearing Abnormality | 11 participants |
Secondary
Number of Participants With a Hearing Aid
Child has a hearing aid. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With a Hearing Aid | 0 participants |
| General Anesthesia | Number of Participants With a Hearing Aid | 3 participants |
Secondary
Number of Participants With Attention Deficit Hyperactivity Disorder
Child has been diagnosed with Attention Deficit Hyperactivity Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With Attention Deficit Hyperactivity Disorder | 3 participants |
| General Anesthesia | Number of Participants With Attention Deficit Hyperactivity Disorder | 4 participants |
Secondary
Number of Participants With Autism Spectrum Disorder
Child has been diagnosis with Autism Spectrum Disorder. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With Autism Spectrum Disorder | 5 participants |
| General Anesthesia | Number of Participants With Autism Spectrum Disorder | 11 participants |
Secondary
Number of Participants With a Visual Defect in Either Eye
Child has a visual defect in either eye. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With a Visual Defect in Either Eye | 21 participants |
| General Anesthesia | Number of Participants With a Visual Defect in Either Eye | 31 participants |
Secondary
Number of Participants With Global Developmental Delay
Child has global developmental delay. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Number of Participants With Global Developmental Delay | 2 participants |
| General Anesthesia | Number of Participants With Global Developmental Delay | 0 participants |
Secondary
Numbers Total Scaled Score
Children's Memory Scale (CMS):Numbers Total scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Numbers Total Scaled Score | 8.3 score on scale | Standard Deviation 3.2 |
| General Anesthesia | Numbers Total Scaled Score | 8.1 score on scale | Standard Deviation 3.4 |
Secondary
Numerical Operations Standard Score
Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Numerical Operations standard score Minimum possible score: 45 Maximum possible score: 145 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Numerical Operations Standard Score | 98.8 score on scale | Standard Deviation 16.2 |
| General Anesthesia | Numerical Operations Standard Score | 96.2 score on scale | Standard Deviation 20.8 |
Secondary
Parents' Awareness of Group Allocation
Whether or not a parent is aware of which treatment group their child was allocated to. This variable will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Parents' Awareness of Group Allocation | 105 caregivers |
| General Anesthesia | Parents' Awareness of Group Allocation | 118 caregivers |
Secondary
Performance IQ
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Performance IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates a higher performance IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Performance IQ | 100.7 score on scale | Standard Deviation 15.2 |
| General Anesthesia | Performance IQ | 101.2 score on scale | Standard Deviation 15.9 |
Secondary
Processing Speed Quotient
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Processing speed quotient Minimum possible score:45 Maximum possible score:145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Processing Speed Quotient | 95.8 score on scale | Standard Deviation 14.5 |
| General Anesthesia | Processing Speed Quotient | 96.3 score on scale | Standard Deviation 15.4 |
Secondary
Psychomotor Interventions
Psychomotor issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Psychomotor Interventions | 8 participants |
| General Anesthesia | Psychomotor Interventions | 6 participants |
Secondary
Sentence Repetition Scaled Score
Developmental Neuropsychological Assessment second edition (NEPSY-II) sub test: Sentence Repetition scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Sentence Repetition Scaled Score | 9.7 score on scale | Standard Deviation 2.9 |
| General Anesthesia | Sentence Repetition Scaled Score | 9.7 score on scale | Standard Deviation 2.8 |
Secondary
Speech or Language Interventions
Speech or language issues/interventions. These variables will be summarised using descriptive statistics by treatment arm only. No treatment effect or confidence intervals will be calculated.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Regional Anesthesia | Speech or Language Interventions | 18 participants |
| General Anesthesia | Speech or Language Interventions | 17 participants |
Secondary
Speeded Naming Combined Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Speeded Naming combined scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Speeded Naming Combined Scaled Score | 9.7 score on scale | Standard Deviation 3 |
| General Anesthesia | Speeded Naming Combined Scaled Score | 9.8 score on scale | Standard Deviation 3.2 |
Secondary
Spelling Standard Score
Weschler Individual Achievement Test (WIAT-II Abbreviated) to Assess the Academic Skills of the Child: Spelling standard score Minimum possible score: 45 Maximum possible score: 145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Spelling Standard Score | 90.1 score on scale | Standard Deviation 13.2 |
| General Anesthesia | Spelling Standard Score | 90.8 score on scale | Standard Deviation 16.5 |
Secondary
Statue Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Statue scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Statue Scaled Score | 8.8 score on scale | Standard Deviation 3.5 |
| General Anesthesia | Statue Scaled Score | 8.6 score on scale | Standard Deviation 3.6 |
Secondary
The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System
Full title: The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System \- 2nd edition (ABAS-II) to measure the child's adaptive behavior. Minimum possible score: 45 Maximum possible score: 145 A higher score indicates a better outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System | 95.9 score on scale | Standard Deviation 16.3 |
| General Anesthesia | The Global Adaptive Composite (GAC) of the Adaptive Behavior Assessment System | 94.1 score on scale | Standard Deviation 16.5 |
Secondary
The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function
Full title: The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function Preschool Version Parent Form (BRIEF-P) to measure behavioural executive abilities. Minimum possible score: 40 Maximum possible score: 110 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a worse outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function | 48.4 score on scale | Standard Deviation 12.5 |
| General Anesthesia | The Global Executive Composite (GEC) of the Behaviour Rating of Executive Function | 51.5 score on scale | Standard Deviation 13.4 |
Secondary
Theory of Mind Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Theory of Mind scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Theory of Mind Scaled Score | 9.8 score on scale | Standard Deviation 2.9 |
| General Anesthesia | Theory of Mind Scaled Score | 9.3 score on scale | Standard Deviation 3 |
Secondary
Total Problems Score
Child Behaviour Checklist Caregiver Questionnaire (CBCL): Total Problems Score to measure behavioural problems Minimum possible score: 40 Maximum possible score: 100 A higher score indicates a worse outcome. Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Total Problems Score | 44.6 score on scale | Standard Deviation 11.7 |
| General Anesthesia | Total Problems Score | 46.7 score on scale | Standard Deviation 12.5 |
Secondary
Verbal IQ
Wechsler Preschool and Primary Scale of Intelligence, Third Edition (WPPSI-III): Verbal IQ Minimum possible score:45 Maximum possible score:145 A higher score indicates higher verbal IQ (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment.
Time frame: At 5 years corrected age.
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Verbal IQ | 101.8 score on scale | Standard Deviation 14.7 |
| General Anesthesia | Verbal IQ | 100.9 score on scale | Standard Deviation 15.4 |
Secondary
Word Generation Scaled Score
Developmental Neuropsychological Assessment Second Edition (NEPSY-II) Sub Test: Word Generation Scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years corrected age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Word Generation Scaled Score | 9.4 score on scale | Standard Deviation 3.4 |
| General Anesthesia | Word Generation Scaled Score | 9.3 score on scale | Standard Deviation 3.3 |
Secondary
Word Lists 1 (Learning) Scaled Score
Children's Memory Scale (CMS): Word Lists 1 (learning) scaled score Minimum possible score: 1 Maximum possible score: 19 A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Word Lists 1 (Learning) Scaled Score | 8.3 score on scale | Standard Deviation 3.4 |
| General Anesthesia | Word Lists 1 (Learning) Scaled Score | 8.6 score on scale | Standard Deviation 3.5 |
Secondary
Word Reading Standard Score
Weschler Individual Achievement Test (WIAT-II Abbreviated) to assess the academic skills of the child: Word Reading standard score Minimum possible score: 45 Maximum possible score: 145 Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after access to the physical assessment booklets is restored. The current health situation prohibits the research team from verifying this information at the moment. A higher score indicates a better outcome.
Time frame: At 5 years chronological age
Population: Not all participants had data collected for this Outcome Measure due to absence at follow up visit.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Regional Anesthesia | Word Reading Standard Score | 92.3 score on scale | Standard Deviation 18.1 |
| General Anesthesia | Word Reading Standard Score | 92.8 score on scale | Standard Deviation 211 |