The effects of anaesthesia on neurodevelopmental outcome and apnoe in infants: the GAS study.

Phase 4

Completed

Conditions: anesthesiologie
neurodevelopmental outcome
10010335

Registration Number: NL-OMON38102

Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 40

Inclusion Criteria

Any infant scheduled for unilateral or bilateral inguinal hernia repair (with or without circumcision)
Any infant whose gestational age (GA) is 26 weeks or more
Any infant whose post-menstrual age (PMA) is up to 60 weeks.

Exclusion Criteria

1. Any child older than 60 weeks post-menstrual age
2. Any child born at less than 26 weeks gestation
3. Any contraindication to general or spinal/caudal anaesthesia (for example: neuromuscular disorder or coagulopathy)
4. Pre-operative ventilation immediately prior to surgery
5. Congenital heart disease that has required surgery or will require surgery or which requires ongoing pharmacotherapy
6. Known chromosomal abnormality or any other known acquired or congenital abnormalities (apart from prematurity) which are likely to affect development
7. Children where follow-up would be difficult for geographic or social reasons
8. Families where Dutch is not the language spoken at home
9. Known neurological injury such as cystic periventricular leukomalacia (PVL), or grade 3 or 4 intra-ventricular haemorrhage (IVH) (+/- post-haemorrhage ventricular dilatation)
10. Previous exposure to volatile anaesthesia or benzodiazepines as a neonate or in the third trimester in utero

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary outcome will be the WPPSI-III Full Scale IQ score at 5 years<br /><br>corrected age. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>1) Other measures of neurodevelopmental outcome<br /><br>2) Incidence of apnoea<br /><br>3) Other outcomes relating to anaesthesia group<br /><br>4) Incidental outcomes not related to choice of anaesthesia</p><br>