Status:
COMPLETED
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
Lead Sponsor:
Boston Children's Hospital
Collaborating Sponsors:
Royal Children's Hospital
Royal Hospital for Sick Children
Conditions:
Inguinal Hernia
Eligibility:
All Genders
Up to 60 years
Phase:
PHASE4
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 neurod...
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 23 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2018
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00756600
Start Date
October 23 2006
End Date
June 30 2018
Last Update
April 29 2020
Active Locations (30)
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1
The Children's Hospital Denver
Aurora, Colorado, United States, 80045
2
Children's Memorial Hospital
Chicago, Illinois, United States, 60614
3
The University of Iowa Hospital
Iowa City, Iowa, United States, 52242
4
Children's Hospital Boston
Boston, Massachusetts, United States, 02115