Research

Preterm Infant Feeding Study

Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants for a patent ductus arteriosus (PDA)

Protocol Description

The main objective of this study is to determine benefits of feeding premature babies with milk while they are receiving indomethacin or ibuprofen for treatment for patent ductus arteriosus (PDA), a condition in which a connecting blood vessel between the aorta and pulmonary artery stays open after birth creating circulation problems. The present standard of care for infants with PDA is intravenous treatment with indomethacin or ibuprofin, and most neonatologists withhold feedings during this therapy. Researchers hypothesize that feeding preterm infants during therapy will decrease the incidence of feeding intolerance and shorten the time infants need to tolerate full enteral nutrition.

Eligibility Criteria

To be considered for the study, infants must be admitted to the Neonatal Intensive Care Unit of Magee-Womens Hospital and be less than 31 weeks gestational age and have a birth weight of 401 to 1250 grams (14 ounces to 2.75 pounds), receiving or are scheduled to begin oral feedings, and about to receive pharmacologic treatment to close their PDA.
Boys: Less than 31 weeks, gestational age
Girls: Less than 31 weeks, gestational age

Requirements
Enrolled infants will be randomly assigned one of the two study medications and whether or not oral feedings will be provided during the drug therapy. Echocardiograms and ultrasound procedures will also be done.
Visits: None beyond normal clinical care
Duration: Not applicable

Status: Open for Enrollment

Source(s) of Support
Gerber Foundation

Additional Resources
Study description at National Institutes of Health