Status:
COMPLETED
SAFEstart Feeding Intolerance Study Phase II
Lead Sponsor:
Intermountain Health Care, Inc.
Conditions:
Feeding Intolerance
Abdominal Distention
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
Feeding intolerance is a common problem in the NICU. Feeding intolerance complicates the hospitalization, lengthens the hospital stay, and adds substantially to the cost of care. We developed a method...
Detailed Description
Feeding intolerance is relatively common in the NICU. It can manifest as emesis, diarrhea, increased abdominal girth (bloating), or in the most severe cases as necrotizing enterocolitis. Feeding intol...
Eligibility Criteria
Inclusion
- Have feeding intolerance (defined in the following section).
- Be expected (by declaration of the Attending Neonatologist) to survive at least 28 days.
- Have documented informed consent for participation in the study.
Exclusion
- Have a congenital surgical condition involving the intestine, such as tracheoesophageal fistulae, diaphragmatic hernia, Hirschprung's disease, bowel atresia, gastroschisis, or omphalocele.
- Be so ill as to require mechanical ventilation with \>50% FIO2 at the time of study entry.
Key Trial Info
Start Date :
July 1 2005
Trial Type :
INTERVENTIONAL
End Date :
April 1 2006
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00331201
Start Date
July 1 2005
End Date
April 1 2006
Last Update
November 28 2006
Active Locations (1)
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1
McKay-Dee Hospital Center
Ogden, Utah, United States, 84403