Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

Not Applicable

Completed

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 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

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 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
ibuprofen-feeding	feeding	Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen and 24 hours after the last dose of ibuprofen.
indomethacin-fasting	fasting	Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of indomethacin and 24 hours after the last dose of indomethacin.
ibuprofen-fasting	fasting	Study infants will be fasted during the study drug period.The study drug period is defined as the interval between administration of the first dose of ibuprofen and 24 hours after the last dose of ibuprofen.
indomethacin-feeding	feeding	Study infants will receive trophic enteral nutrition (15 ml/kg/day) during the study drug period.The study drug period is defined as the interval between administration of the first dose of indomethacin and 24 hours after the last dose of indomethacin.

Primary Outcome Measures

Name	Time	Method
Assess the effect of feeding infants during indomethacin or ibuprofen therapy on the incidence of feeding intolerance and the number of days required to achieve full feedings (120 ml/kg/day).	4 years

Secondary Outcome Measures

Name	Time	Method
incidence of necrotizing enterocolitis or spontaneous perforation	4 years
Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.	4 years
Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.	4 years

Locations (14): Boston University-Boston Medical Center
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Boston, Massachusetts, United States
Children's Hospital-Saint Paul
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Saint Paul, Minnesota, United States
Atlantic Health Organization
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Morristown, New Jersey, United States
Santa Clara Valley Medical Center
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San Jose, California, United States
Children's Memorial Hospital-Northwestern University
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Chicago, Illinois, United States
University of Pittsburgh
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Pittsburgh, Pennsylvania, United States
North Shore University Health System, Northwestern University
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Evanston, Illinois, United States
Columbia University
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New York, New York, United States
Case Western Reserve
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Cleveland, Ohio, United States
University of Virginia, Charlottesville
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Charlottesville, Virginia, United States
Children's Hospital-Minneapolis
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Minneapolis, Minnesota, United States
Mayo Clinic
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Rochester, Minnesota, United States
Vanderbilt University
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Nashville, Tennessee, United States
University of California san Francisco
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San Francisco, California, United States