Multi-Institutional Cohort Study of a Non-invasive Technique for Bedside Reduction of Giant Omphaloceles
M
Matthew Landman, MD
Primary Investigator
Enrolling By Invitation
1 weeks or below
All
Phase
N/A
2 participants needed
1 Location
Brief description of study
WHY IS THIS STUDY BEING DONE?
The main reason for this research study is to understand what happens with patients who are treated for giant omphaloceles (GO) using a non-invasive staged closure technique that uses a hydrocolloid (Duoderm CGF) silo. Omphaloceles are a rare (birth) defect where infants are born with incomplete closure of the muscle/tough layer of the abdominal wall.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Infants who are born with a giant omphalocele (GO) that cannot be immediately closed and are treated by pediatric surgeons at Riley Hospital for Children following birth will be invited to participate in this study.
Detailed description of study
WHAT WILL HAPPEN DURING THE STUDY?
Participants will have standard of care procedures to correct the giant omphaloceles. Participants will allow us to access medical records to collect information about the surgery and participants' continued health status. In addition, the Cincinnati Children’s Hospital Medical Center (CCHMC) will contact participants with follow-up questions after the surgery and at 1, 3 and 5 years after. We will contact participants with reminders by phone, text, email and letter, if necessary.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Giant omphaloceles (GO), Riley
-
Age: 1 weeks or below
-
Gender: All
Inclusion Criteria:
- Neonates born with a giant omphalocele that is unable to be primarily closed.
- Guardian consent for participation.
- Treated by pediatric surgeons at one of the participating institutions immediately following birth (not initially managed at an outside facility and subsequently transferred). Outborn infants transferred to treating center in first week of life are permitted.
Exclusion Criteria:
- Guardian declined participation.
- Grossly ruptured omphalocele sac at delivery
- Severe pulmonary hypertension and/or high ventilatory requirements.
Updated on
23 Apr 2025.
Study ID: SURG-MIDWEST-GO, 15431
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