Status:
COMPLETED
Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants
Lead Sponsor:
University of California, San Francisco
Conditions:
Patent Ductus Arteriosus
Eligibility:
All Genders
23-33 years
Phase:
NA
Brief Summary
We hypothesize that feeding preterm infants while they receive indomethacin or ibuprofen therapy for treatment of a patent ductus arteriosus will decrease the incidence of feeding intolerance and shor...
Detailed Description
This study is a randomized controlled multi-center clinical trial to determine whether very low birth weight infants should receive feedings during indomethacin or ibuprofen treatment of a patent duct...
Eligibility Criteria
Inclusion
- Infants between 401-1,250 g birth weight who
- Are receiving or are scheduled to begin enteral feedings and
- Are about to receive pharmacologic treatment (either indomethacin or ibuprofen) to close their PDA.
Exclusion
- Serious congenital malformations
- Chromosomal anomalies
- Congenital or acquired gastrointestinal anomalies
- Prior episode of necrotizing enterocolitis
- Use of inotropic support for hypotension
- Renal anomalies or disease
- Are receiving \> 80 ml/kg/d of enteral feeding
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2012
Estimated Enrollment :
177 Patients enrolled
Trial Details
Trial ID
NCT00728117
Start Date
July 1 2008
End Date
September 1 2012
Last Update
November 9 2012
Active Locations (14)
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1
University of California san Francisco
San Francisco, California, United States, 94143
2
Santa Clara Valley Medical Center
San Jose, California, United States, 95128
3
Children's Memorial Hospital-Northwestern University
Chicago, Illinois, United States, 60614
4
North Shore University Health System, Northwestern University
Evanston, Illinois, United States, 60201