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NCT00756600 · ClinicalTrials.gov registry record · Phase 4
A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants
A Phase 4 study, sponsored by Boston Children's Hospital.
- Completed
- Registry status
- Phase 4
- Development phase
- 643
- Enrollment target
NCT00756600: Completed Phase 4 study, sponsored by Boston Children's Hospital.
NCT00756600 is a Phase 4 study that has completed, run by Boston Children's Hospital. The registered enrollment target is 643 participants, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00756600, a Phase 4 study, has completed, sponsored by Boston Children's Hospital.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 643 participants
- Enrollment target
Study 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 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.
Primary Outcome
The primary outcome will be the Wechsler Preschool and Primary Scale of Intelligence-Third Edition (WPPSI-III) full scale IQ score. Verbal, visuo-spatial and processing speed skills are incorporated into the Full Scale IQ score, which is indicative of general intellectual ability. Minimum score: 45 Maximum score:145 Higher scores are associated with higher IQ scores (better outcome). Note: Scale ranges represent estimates that are very likely to be accurate but which will be verified after acc
Interventions
- DRUG Regional Anesthesia
- DRUG General Anesthesia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 643 participants |
| Start Date | 2006-10-23 |
| Est. Completion | 2018-06-30 |
| Phase | Phase 4 |
What the finished NCT00756600 record still lists
NCT00756600 is an interventional study that assigns participants to a tested intervention. The registered 643 participants enrollment target is mid-sized for trials with a published cap, above the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (24% higher).
The record links to 0 conditions, and to 2 interventions - of which Regional Anesthesia is the first listed.
NCT00756600 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00756600 about?
NCT00756600 is a clinical study titled "A Multi-site Randomized Controlled Trial Comparing Regional and General Anesthesia for Effects on Neurodevelopmental Outcome and Apnea in Infants". 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 ...
What is the current status of trial NCT00756600?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 643 participants. The study started on 2006-10-23. Estimated completion is 2018-06-30.
What interventions are being tested in trial NCT00756600?
The interventions under investigation include: Regional Anesthesia (DRUG), General Anesthesia (DRUG).
Who is sponsoring clinical trial NCT00756600?
This trial is sponsored by Boston Children's Hospital, which has 462 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00756600's enrollment target sits among peer trials
643 126th of 2000 higher than 1,875 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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