Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

University of California San Francisco (UCSF)

Status: Completed

Conditions: Patent Ductus Arteriosus

Treatments: Other: fasting; Other: feeding

Study type: Interventional

Funder types: Other

Identifiers

NCT00728117

RC3

Details and patient eligibility

About

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

Full 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.

Enrollment: 177 patients

Sex: All

Ages: 23 to 33 weeks old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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177 participants in 4 patient groups

ibuprofen-feeding

Experimental group

Description:

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.

Treatment:

Other: feeding

ibuprofen-fasting

Experimental group

Description:

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.

Treatment:

Other: fasting

indomethacin-feeding

Experimental group

Description:

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.

Treatment:

Other: feeding

indomethacin-fasting

Experimental group

Description:

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.

Treatment:

Other: fasting