Cerebral Palsy, Early Intervention, Family Centered Care, Prematurity
Conditions
Keywords
cerebral palsy, prematurity, early intervention, parent-driven, brain plasticity, motor outcome
Brief summary
The goal of this project is to investigate the acceptability, feasibility and fidelity of an innovative NICU rehabilitation program that will include six multimodal, gestational age (GA) appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy). Using the general movement assessment (GMA) instrument, the investigators will determine the effects of this program on short-term motor outcomes (general movements (GMs), cranial nerves, posture, movements, tone, and reflexes) in premature infants (≤32 week's gestation and/or ≤1500 grams birthweight) identified as at-risk for CP. The short-term motor outcomes will be measured using the GMA, the Test of Infant Motor Performance (TIMP) and the Hammersmith Infant Neurological Examination (HINE) instruments. This novel program will be applied during the neonatal intensive care unit (NICU) hospitalization when the brain is highly plastic and actively developing with the goal to mitigate severity of brain injury and its impact on development.
Detailed description
The two following specific aims will be tested: Aim 1: Enroll 60 preterm infants (\<32 weeks' gestation and/or ≤1500 grams) with abnormal GMA into a pilot randomized control trial to evaluate the acceptability, feasibility (practicality) and fidelity (adherence, exposure and engagement) of a multimodal GA appropriate rehabilitation program during NICU hospitalization compared to standard of care. The investigators will evaluate: * Acceptability using recruitment, refusal, retention, and follow-up rates as well as weekly interviews with parental participants * Feasibility (practicality) using direct observations and weekly interviews with parental participants * Fidelity (adherence, exposure and engagement) using visitation data, activity logs, direct observations, and weekly interviews. Aim 2: Examine the effect of a multimodal NICU-based rehabilitation program on short-term motor outcomes (general movements, cranial nerves, posture, movements, tone, and reflexes) of premature infants at risk for cerebral palsy (CP) at discharge from the NICU and at 3 months corrected age. The investigators hypothesize that this type of GA appropriate multimodal NICU-based rehabilitation program will positively impact short-term motor outcomes by normalizing general movements and improving TIMP and HINE scores.
Interventions
OTHERNeoRehab Bundle
The NICU rehabilitation program includes six multimodal, GA appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy)
OTHERRoutine care
Routine NICU care including talking, touching and holding the participant per unit guideline as well as physical therapy, occupational therapy, and speech therapy per unit guideline
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Virginia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Randomized controlled trial
Eligibility
Sex/Gender
ALL
Age
23 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
* GA at birth: ≤32 weeks gestation and/or birthweight ≤1500 grams * Infants 7 days or older * Ability of parents or identified designated surrogate (e.g. grandparent) to perform the interventions * Abnormal writhing GMs defined by the presence of a poor repertoire pattern on 2 consecutive assessments or the presence of a cramped-synchronized pattern on any assessment
Exclusion criteria
* Clinically unstable (requiring high frequency mechanical ventilation, vasopressor support, need for continuous intravenous pain or sedation medication) * If their parents do not speak English * If parental participation is hindered (e.g. incarceration).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | from day 1 of study screening through end of screening (approximately 1 year and3 months). | The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period |
| Retention Rates | From discharge to 3 months follow-up | The following measure will be used to assess the retention rate of study participants: \- Rate of follow-up at the 3 month outpatient visit |
| Adherence Rates | from study enrollment (day 1) to study discharge | Adherence rates were monitored by daily activity logs of interventions from enrollment day 1 to discharge for each visit day |
| Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP) | 3 months | Motor outcomes will be assessed at NICU discharge and at 3 months using the Test of Infant Motor Performance (TIMP); 3 months outcome reported. TIMP score range = 0-142; lower scores indicate worse motor performance |
| Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE). | 3 months | Neurologic function will be assessed at NICU discharge and at 3 months postmenstrual age using the Hammersmith Infant Neurological Examination (HINE) instrument, 3 months outcome reported. The HINE is a 26 items scale that evaluates cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Lower the score the poorer the motor function. HINE score range = 0-78 (with lower score indicating lower motor performance). The HINE has a sensitivity of 90% for prediction of motor outcome. |
| Percent Abnormal General Movements | 3 months | The impact of the intervention on the infants' general movement will be assessed at NICU discharge and at 3 months postmenstrual age using the general movement assessment (GMA) tool. The GMA has been shown to reliably identify infants at high risk for CP and can be implemented shortly after birth making it an ideal screening tool for preterm infants. Cramped-synchronized writhing general movements followed by absent fidgety general movements is a movement pattern that has been shown to be highly specific of later development of cerebral palsy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Parent-driven intervention bundle of 6 evidence-based elements: vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy
NeoRehab Bundle: The NICU rehabilitation program includes six multimodal, GA appropriate, parent-administered interventions (vocal soothing, scent exchange, comforting touch, kangaroo care, infant massage and physical therapy) | 34 |
| Routine Care Routine care per unit guidelines
Routine care: Routine NICU care including talking, touching and holding the participant per unit guideline as well as physical therapy, occupational therapy, and speech therapy per unit guideline | 33 |
| Total | 67 |
Baseline characteristics
| Characteristic | Intervention | Routine Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 34 Participants | 33 Participants | 67 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 | 28.02 weeks STANDARD_DEVIATION 2.7 | 28.75 weeks STANDARD_DEVIATION 2.68 | 28.39 weeks STANDARD_DEVIATION 2.69 |
| Race/Ethnicity, Customized Race Black | 8 Participants | 4 Participants | 12 Participants |
| Race/Ethnicity, Customized Race Caucasian | 26 Participants | 29 Participants | 55 Participants |
| Sex: Female, Male Female | 14 Participants | 10 Participants | 24 Participants |
| Sex: Female, Male Male | 20 Participants | 23 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 36 | 1 / 34 |
| other Total, other adverse events | 0 / 36 | 0 / 34 |
| serious Total, serious adverse events | 0 / 36 | 0 / 34 |
Outcome results
Primary
Acceptability
The following measure will be used to measure study acceptability: % Recruitment rates during enrollment period
Time frame: from day 1 of study screening through end of screening (approximately 1 year and3 months).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Study Acceptability | Acceptability | 70 Participants |
Primary
Adherence Rates
Adherence rates were monitored by daily activity logs of interventions from enrollment day 1 to discharge for each visit day
Time frame: from study enrollment (day 1) to study discharge
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Acceptability | Adherence Rates | 0 percentage of participants |
| Control | Adherence Rates | 0 percentage of participants |
Primary
Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP)
Motor outcomes will be assessed at NICU discharge and at 3 months using the Test of Infant Motor Performance (TIMP); 3 months outcome reported. TIMP score range = 0-142; lower scores indicate worse motor performance
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Study Acceptability | Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP) | 86 score on a scale |
| Control | Impact of the NeoRehab Bundle on Motor Performance Using the Test of Infant Motor Performance (TIMP) | 91 score on a scale |
Primary
Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE).
Neurologic function will be assessed at NICU discharge and at 3 months postmenstrual age using the Hammersmith Infant Neurological Examination (HINE) instrument, 3 months outcome reported. The HINE is a 26 items scale that evaluates cranial nerve function, posture, quality and quantity of movements, muscle tone, and reflexes and reactions. Lower the score the poorer the motor function. HINE score range = 0-78 (with lower score indicating lower motor performance). The HINE has a sensitivity of 90% for prediction of motor outcome.
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Study Acceptability | Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE). | 58.8 score on a scale | Standard Deviation 7.2 |
| Control | Impact of the NeoRehab Bundle on Neurologic Function as Assessed by the Hammersmith Infant Neurological Examination (HINE). | 57.2 score on a scale | Standard Deviation 11.2 |
p-value: 0.0543t-test, 1 sided
Primary
Percent Abnormal General Movements
The impact of the intervention on the infants' general movement will be assessed at NICU discharge and at 3 months postmenstrual age using the general movement assessment (GMA) tool. The GMA has been shown to reliably identify infants at high risk for CP and can be implemented shortly after birth making it an ideal screening tool for preterm infants. Cramped-synchronized writhing general movements followed by absent fidgety general movements is a movement pattern that has been shown to be highly specific of later development of cerebral palsy.
Time frame: 3 months
Population: Abnormal general movements = absent fidgety classification
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Acceptability | Percent Abnormal General Movements | 57 percentage of participants |
| Control | Percent Abnormal General Movements | 54 percentage of participants |
Primary
Retention Rates
The following measure will be used to assess the retention rate of study participants: \- Rate of follow-up at the 3 month outpatient visit
Time frame: From discharge to 3 months follow-up
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Study Acceptability | Retention Rates | 73 percentage of participants |