Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

Completed · Not applicable

Conditions studied: Patent Ductus Arteriosus

In brief

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 shorten the time period that infants need to tolerate full enteral nutrition. We also hypothesize that this intervention will minimize the alterations in intestinal permeability that occur with these drugs and will improve the infants' hemodynamic response to enteral nutrition

Key facts

Study ID

NCT00728117

Run by

University of California, San Francisco

People needed

177

Starts

2008-07-01

Expected to finish

2012-09-01

Last updated by the study team

2012-11-09

Who can join

Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of California san Francisco — San Francisco, California, United States
• Santa Clara Valley Medical Center — San Jose, California, United States
• Children's Memorial Hospital-Northwestern University — Chicago, Illinois, United States
• North Shore University Health System, Northwestern University — Evanston, Illinois, United States
• Boston University-Boston Medical Center — Boston, Massachusetts, United States
• Children's Hospital-Minneapolis — Minneapolis, Minnesota, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Children's Hospital-Saint Paul — Saint Paul, Minnesota, United States
• Atlantic Health Organization — Morristown, New Jersey, United States
• Columbia University — New York, New York, United States
• Case Western Reserve — Cleveland, Ohio, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University — Nashville, Tennessee, United States
• University of Virginia, Charlottesville — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.