EUCTR2006-006295-37-GBActive, not recruitingPhase 1
A multi-site RCT comparing regional and general anaesthesia for effects on neurodevelopmental outcome and apnoea in infants. - The GAS Study
HS Greater Glasgow & Clyde0 sites660 target enrollmentStarted: March 29, 2007Last updated:
Conditions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 660
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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
Investigators
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