Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

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Brief Title

Feeding During Ibuprofen or Indomethacin Treatment of Preterm Infants

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

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.
    


Study Type

Interventional


Primary Outcome

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).

Secondary Outcome

 incidence of necrotizing enterocolitis or spontaneous perforation

Condition

Patent Ductus Arteriosus

Intervention

feeding

Study Arms / Comparison Groups

 ibuprofen-feeding
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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

177

Start Date

July 2008

Completion Date

September 2012

Primary Completion Date

July 2012

Eligibility 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
      

Gender

All

Ages

23 Weeks - 33 Weeks

Accepts Healthy Volunteers

No

Contacts

Ronald Clyman, M.D., , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00728117

Organization ID

RC3


Responsible Party

Sponsor

Study Sponsor

University of California, San Francisco


Study Sponsor

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


Verification Date

November 2012