A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants

Completed · Phase 4

Conditions studied: Inguinal Hernia

In brief

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 neurodevelopmental outcomes. The study also aims to describe the incidence of apnea in the post-operative period after both regional and general anesthesia for inguinal hernia repair in infants. This study is important as it will provide the greatest evidence for safety or toxicity of general anesthesia for human infants.

Key facts

Study ID

NCT00756600

Run by

Boston Children's Hospital

People needed

643

Starts

2006-10-23

Expected to finish

2018-06-30

Last updated by the study team

2020-04-29

Who can join

Age: any, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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.

Where it is running

• The Children's Hospital Denver — Aurora, Colorado, United States
• Children's Memorial Hospital — Chicago, Illinois, United States
• The University of Iowa Hospital — Iowa City, Iowa, United States
• Children's Hospital Boston — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Vanderbilt Children's Hospital — Nashville, Tennessee, United States
• Children's Medical Center of Dallas — Dallas, Texas, United States
• Vermont Children's Hospital at Fletcher Allen Health Care — Burlington, Vermont, United States
• Seattle Children's Hospital — Seattle, Washington, United States
• Adelaide Women's and Children's Hospital — North Adelaide, South Australia, Australia
• Casey Hospital — Berwick, Victoria, Australia
• Monash Medical Centre — Clayton, Victoria, Australia
• Cabrini Hospital — Malvern, Victoria, Australia
• Royal Children's Hospital — Parkville, Victoria, Australia
• Princess Margaret Hospital — Perth, Western Australia, Australia
• Montreal Children's Hospital — Montreal, Quebec, Canada
• Centre Hospitalier Universitaire Sainte-Justine — Montreal, Quebec, Canada
• Ospedali Riuniti Di Bergamo — Bergamo, Italy
• G. Gaslini Children's Hospital — Genoa, Italy
• 'Vitore Buzzi' Children's Hospital — Milan, Italy
• Universitair Medisch Centrum Groningen — Groningen, Netherlands
• Wilhelmina Children's Hospital; University Medical Centre Utrecht — Utrecht, Netherlands
• Starship Children's Health — Auckland, New Zealand
• Royal Belfast Hospital for Sick Children — Belfast, United Kingdom

Full record on ClinicalTrials.gov

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