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Indomethacin prophylaxis for preterm infants: the impact of 2 multicentered randomized controlled trials on clinical

Ronald I Clyman1, Shampa Saha, Alan Jobe

  • 1Cardiovascular Research Institute and Department of Pediatrics, University of California San Francisco, San Francisco, CA 94143-0544, USA. clymanr@peds.ucsf.edu

The Journal of Pediatrics
|December 26, 2006
PubMed

Insights

Publication of two trials impacted indomethacin prophylaxis use in premature infants. The Ment trial increased its use, while the TIPP trial decreased it due to an overly ambitious effect size.

Area of Science:

  • Neonatal Medicine
  • Clinical Trials
  • Pharmacology

Background:

  • Two multicenter randomized controlled trials (RCTs) investigated indomethacin prophylaxis in premature infants.
  • The Ment trial (1994) showed benefits for patent ductus arteriosus (PDA), PDA ligation, and severe intracranial hemorrhage (ICH).
  • The TIPP trial (2001) did not find benefits in its primary outcome, potentially discouraging prophylaxis.

Purpose of the Study:

  • To determine the association between the Ment and TIPP trials and the clinical use of indomethacin prophylaxis.
  • To statistically assess the assumptions underlying the TIPP trial's negative findings.

Main Methods:

  • Utilized the National Institute of Child Health and Development's Neonatal Network Registry.
  • Analyzed trends in indomethacin prophylaxis use following the publication of each trial.
  • Performed statistical assessment of the TIPP trial's effect size calculations.

Main Results:

  • Indomethacin prophylaxis use increased among network clinicians after the Ment trial publication.
  • Indomethacin prophylaxis use decreased following the TIPP trial publication.
  • The TIPP trial's anticipated effect size of >= 20% was deemed too large; a < 3% effect size was more appropriate given the ICH incidence and neurodevelopmental outcomes.

Conclusions:

  • The Ment and TIPP RCTs significantly influenced the adoption of indomethacin prophylaxis in premature infants.
  • The Ment trial's positive findings led to increased prophylaxis use.
  • The TIPP trial's negative results, stemming from an overestimated effect size, led to decreased prophylaxis use.
Abstract

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