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NCT02774746 · ClinicalTrials.gov registry record · NA
Gastroschisis Outcomes of Delivery (GOOD) Study
A NA study of Gastroschisis, sponsored by Medical College of Wisconsin.
- Recruiting
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT02774746: Recruiting NA study of Gastroschisis, sponsored by Medical College of Wisconsin.
NCT02774746 is a NA study of Gastroschisis that is actively recruiting participants, run by Medical College of Wisconsin. The registered enrollment target is 300 participants, above the 22-participant average among 4 other Gastroschisis trials with a reported enrollment target (1264% higher). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02774746, a NA study of Gastroschisis, is actively recruiting participants, sponsored by Medical College of Wisconsin.
- RECRUITING
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prospective, multi-institutional trial across NAFTNet-affiliated institutions. Patients may be enrolled in the study any time prior to 33 weeks, but will be randomized at 33 weeks to delivery at 35 weeks or observation with a goal of 38 weeks. The primary composite outcome will include stillbirth, neonatal death prior to discharge, respiratory morbidity, and need for parenteral nutrition at 30 days.
Primary Outcome
The primary outcome is the composite endpoint combining the following three clinical risks: (1) intrauterine fetal demise, (2) neonatal/infant death prior to neonatal intensive care unit (NICU) discharge, (3) sepsis. The probability of the composite endpoint will be compared between groups as defined by the ITT population using a one-sided test at a 2.3% nominal significance level for the alternative hypothesis that the experimental early delivery group has lower probability of the composite en
Conditions Studied
Interventions
- OTHER 35-week delivery
- OTHER 38-week delivery
Study Locations (20)
California
- Loma Linda University Children's Hospital - Loma Linda
- Lucile Packard Children's Hospital Stanford - Stanford
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
- OSF St. Francis Medical Center - Peoria
Maryland
- University of Maryland, Baltimore - Baltimore
- Johns Hopkins Hospital - Baltimore
Massachusetts
- Brigham and Women's Hospital & Boston Children's Hospital - Boston
- Beth Israel Deaconess Medical Center - Boston
Missouri
- Children's Mercy Hospital - Kansas City
- St. Louis University, SSM Health Cardinal Glennon Children's Hospital & SSM Health St. Mary's Hospital - St Louis
Arizona
- Phoenix Children's Hospital - Phoenix
Colorado
- Children's Hospital of Colorado - Aurora
Connecticut
- Connecticut Children's Medical Center - Hartford
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2018-02-23 |
| Est. Completion | 2029-03-31 |
| Phase | NA |
What NCT02774746 shows while recruiting
NCT02774746 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, above the 22-participant average among 4 other Gastroschisis trials with a reported enrollment target (1264% higher).
The record links to 1 condition, with Gastroschisis appearing as the primary indexed condition, and to 2 interventions - of which 35-week delivery is the first listed.
NCT02774746 names 20 study sites across 15 states, led by California, Illinois, Maryland.
Frequently Asked Questions
What is clinical trial NCT02774746 about?
NCT02774746 is a clinical study titled "Gastroschisis Outcomes of Delivery (GOOD) Study". The objective of this study is to investigate the hypothesis that delivery at 35 0/7- 35 6/7 weeks in stable patients with gastroschisis is superior to observation and expectant management with a goal of delivery at 38 0/7 - 38 6/7 weeks. To test this hypothesis, we will complete a randomized, prosp...
What is the current status of trial NCT02774746?
This trial is currently recruiting. It is a NA study. The enrollment target is 300 participants. The study started on 2018-02-23. Estimated completion is 2029-03-31.
What conditions does trial NCT02774746 study?
This clinical trial studies the following conditions: Gastroschisis.
What interventions are being tested in trial NCT02774746?
The interventions under investigation include: 35-week delivery (OTHER), 38-week delivery (OTHER).
Who is sponsoring clinical trial NCT02774746?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02774746 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Delaware. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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