Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00728117
First received: July 31, 2008
Last updated: November 8, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention
Patent Ductus Arteriosus
Other: feeding
Other: fasting

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • incidence of necrotizing enterocolitis or spontaneous perforation [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Assess the effect of feeding very low birth weight infants during indomethacin or ibuprofen therapy on intestinal permeability. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 177
Study Start Date: July 2008
Study Completion Date: September 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   23 Weeks to 33 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00728117

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

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00728117     History of Changes
Other Study ID Numbers: RC3
Study First Received: July 31, 2008
Last Updated: November 8, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
indomethacin
ibuprofen
preterm infant

Additional relevant MeSH terms:
Ductus Arteriosus, Patent
Cardiovascular Abnormalities
Cardiovascular Diseases
Congenital Abnormalities
Heart Defects, Congenital
Heart Diseases
Ibuprofen
Indomethacin
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Cardiovascular Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Sensory System Agents
Therapeutic Uses
Tocolytic Agents

ClinicalTrials.gov processed this record on October 30, 2014