Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

November 8, 2012 updated by: University of California, San Francisco

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

177

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94143
        • University of California San Francisco
      • San Jose, California, United States, 95128
        • Santa Clara Valley Medical Center
    • Illinois
      • Chicago, Illinois, United States, 60614
        • Children's Memorial Hospital-Northwestern University
      • Evanston, Illinois, United States, 60201
        • North Shore University Health System, Northwestern University
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston University-Boston Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55404
        • Children's Hospital-Minneapolis
      • Rochester, Minnesota, United States, 85359
        • Mayo Clinic
      • Saint Paul, Minnesota, United States, 55102
        • Children's Hospital-Saint Paul
    • New Jersey
      • Morristown, New Jersey, United States, 07962
        • Atlantic Health Organization
    • New York
      • New York, New York, United States, 10032
        • Columbia University
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Case Western Reserve
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15122
        • University of Pittsburgh
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia, Charlottesville

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ibuprofen-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.
Other: 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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
Experimental: ibuprofen-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.
Other: 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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
Experimental: indomethacin-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.
Other: 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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.
Experimental: indomethacin-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.
Other: 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 or indomethacin and 24 hours after the last dose of ibuprofen or indomethacin.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
incidence of necrotizing enterocolitis or spontaneous perforation
Time Frame: 4 years
4 years
Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability.
Time Frame: 4 years
4 years
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
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Investigators

  • Principal Investigator: Ronald Clyman, M.D., University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

July 1, 2012

Study Completion (Actual)

September 1, 2012

Study Registration Dates

First Submitted

July 31, 2008

First Submitted That Met QC Criteria

August 4, 2008

First Posted (Estimate)

August 5, 2008

Study Record Updates

Last Update Posted (Estimate)

November 9, 2012

Last Update Submitted That Met QC Criteria

November 8, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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