Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

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 ductus arteriosus (PDA). Many neonatologists withhold feeds from premature
infants receiving indomethacin or ibuprofen therapy for a PDA because of concerns that these
drugs alter intestinal blood flow and permeability. However, there are no established
studies which show that feeding during these medical treatments leads to bowel injury. At
the same time, studies suggest that withholding feedings from premature infants may lead to
intestinal atrophy and injury, leading to increased difficulty with feedings when they are
initiated or re-started. Thus, this multi-center study evaluates whether feeding infants
during indomethacin or ibuprofen therapy improves feeding tolerance by measuring the number
of episodes of feeding intolerance and the number of days required to attain full feedings.
In addition, this study will employ techniques to measure gastrointestinal permeability and
mesenteric blood flow in patients who receive and don't receive feedings for their PDA
treatment.

Inclusion Criteria:

- 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 Criteria:

- 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