Status:
TERMINATED
Evaluation of Glycerin Suppositories to Improve Bowel Function in Gastroschisis
Lead Sponsor:
Indiana University
Conditions:
Gastroschisis
Eligibility:
All Genders
1-1 years
Phase:
PHASE4
Brief Summary
Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall,...
Detailed Description
Gastroschisis is a congenital defect of the abdominal wall that leads to evisceration of various amounts of the abdominal organs. The mainstay of therapy is restoring continuity of the abdominal wall,...
Eligibility Criteria
Inclusion
- Diagnosis of uncomplicated gastroschisis
- Gestational age \>33 weeks at time of delivery
- Weight \>1900g at time of delivery
- Transfer of patient to Riley Hospital for Children prior to any abdominal surgery
Exclusion
- Neurological Congenital malformations and/or those known to impair intestinal motility
- Additional congenital gastrointestinal abnormalities requiring surgical intervention
- Congenital Cyanotic heart disease
- Surgical Closure of abdominal wall defect with prosthetic material (e.g. prosthetic or bio-prosthetic mesh)
Key Trial Info
Start Date :
October 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT03355326
Start Date
October 1 2017
End Date
October 1 2020
Last Update
October 12 2021
Active Locations (1)
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1
Riley Hospital for Children
Indianapolis, Indiana, United States, 46202