Inguinal hernia in neonates and infants MedDRA version: 8.1 Level: PT Classification code 10022016 Term: Inguinal hernia
Conditions
Interventions
Trade Name: Sevoflurane (Abbott Laboratories Ltd)
Product Name: Sevoflurane
Pharmaceutical Form: Inhalation vapour, liquid
INN or Proposed INN: SEVOFLURANE
CAS Number: 28523866
Concentration unit: ml
Sponsors
NHS Greater Glasgow & Clyde
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Any child scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • Any child older than 60 weeks post menstrual age • Any child born at less than 26 weeks gestation • Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy) • Pre-operative ventilation immediately prior to surgery • Congenital heart disease that has required surgery or will require surgery or which requires 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 the primary language spoken at home is not the language in which the WPSI-III will be given [i.e. English for Australian sites, French for Paris site and English or Spanish for US sites] • Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra ventricular haemorrhage (IVH) (+/- post haemorrhage ventricular dilatation) • Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this trial is to determine whether different types of anaesthesia [regional versus general] given to infants undergoing inguinal hernia repair result in equivalent neurodevelopmental outcomes. ;Secondary Objective: Secondary objectives are to describe the frequency and characteristics of apnoea in the post-operative period after both regional and general anaesthesia for inguinal hernia repair in infants, and determine the factors associated with apnoea.;Primary end point(s): 6.1 Primary outcome The primary outcome will be the WPPSI-III Full Scale IQ score at 5 years corrected age. 6. 2 Secondary outcomes Secondary outcomes fall into four areas: 1) Other measures of neurodevelopmental outcome 2) Incidence of apnoea 3) Other outcomes relating to anaesthesia group 4) Incidental outcomes not related to choice of anaesthesia 6.2.1 Other measures of neurodevelopmental outcome 6.2.1.1 Neurodevelopmental secondary outcomes at 2 years: • Cognitive, motor and language scales of the Bayley Scales of Infant Development III [Bayley 2005]. • A paediatric assessment including a neurological examination to determine the presence of cerebral palsy will be conducted by a paediatrician blinded to the type of anaesthetic used. • Data regarding visual and hearing acuity will be collected, or where not previously conducted, visual and audiology assessments will be arranged. • Some sites will perform the experimental Delayed Alternation and Spatial Reversal tasks (Espy) 6.2.1.2 School age developmental outcome at 5 years: • A paediatric assessment as per 2 years. • General intellectual ability, verbal, visuo-spatial and processing speed skills are incorporated into the Wechsler Preschool and Primary Scale of Intelligence - Third Edition (WPPSI-III) The primary outcome is the full scale, while subscales will be computed as secondary outcomes. • Auditory and visual attention will be assessed using the NEPSY tasks. • The behaviour feat | — |
Countries
Netherlands, United Kingdom
Outcome results
None listed