Skip to main content
OpenTrials
Completed

NCT Number: NCT00728117

Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Patent Ductus Arteriosus Cardiovascular Abnormalities Cardiovascular Diseases Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Ductus Arteriosus, Patent Female Urogenital Diseases and Pregnancy Complications Heart Defects, Congenital Heart Diseases Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

23 week–33 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California san Francisco, San Francisco, California, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Feeding

Other

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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.

Fasting

Other

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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.

Primary outcomes

  1. 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).

    Time frame: 4 years

Secondary outcomes

  1. incidence of necrotizing enterocolitis or spontaneous perforation

    Time frame: 4 years

  2. Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.

    Time frame: 4 years

  3. Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on the normal hyperemic response to feeding.

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Should Very Low Birth Weight Infants Receive Enteral Nutrition During Indomethacin or Ibuprofen Treatment of a Patent Ductus Arteriosus? A Multi-Center Randomized Controlled Trial

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Aug 5, 2008
Registry last updated
Nov 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.