Indomethacin reduces the risks of severe intraventricular hemorrhage

Henrietta S. Bada, Robert S. Green, Massroor Pourcyrous, Charles W. Leffler, Sheldon B. Korones, H. Lynn Magill, Kris Arheart, Charles W. Fitch, Garland D. Anderson, Grant Somes, Kay Tullis, Julia Campbell

Research output: Contribution to journalArticlepeer-review

93 Scopus citations


A prospective, random selection, double-blind clinical trial was carried out to determine the efficacy of indomethacin in preventing periventricular-intraventricular hemorrhage (PV-IVH). Babies who were born in our institution, had birth weights ≤1500 gm, and had no PV-IVH or grade 1 PV-IVH were given either placebo (n=70) or indomethacin (n=71), 0.2 mg/kg intravenously at 6 hours of age and 0.1 mg/kg at 18 and 30 hours. Two major outcomes were determined: the development of grades 2 to 4 PV-IVH and the development of severe PV-IVH (i.e., hemorrhages with blood filling >50% of the ventricles and in some cases with associated parenchymal echodensities). Grades 2 to 4 PV-IVH occurred in 16 (23%) of the indomethacin group and 27 (39%) of the placebo group (p<0.03). The incidence of severe PV-IVH was 3% in the indomethacin-treated babies and 14% in the control group (p<0.02). The influence of other perinatal factors on the incidence of grades 2 to 4 or severe PV-IVH was determined by stepwise logistic regression. Placebo use, early grade 1 PV-IVH, lower birth weight, and higher fraction of inspired oxygen at 6 hours of life were associated with higher estimated odds of the development of grades 2 to 4 PV-IVH. Placebo use, male gender, lower 5-minute Apgar score, and a large base deficit were predictive of severe PV-IVH. Estimated odds ratios of severe PV-IVH with placebo use and male gender were 11.251 and 91, respectively. Thus indomethacin prophylaxis reduced the relative risk of grades 2 to 4 PV-IVH and severe PV-IVH, but other perinatal variables contributed significantly to the overall risk of PV-IVH.

Original languageEnglish
Pages (from-to)631-637
Number of pages7
JournalJournal of Pediatrics
Issue number4
StatePublished - Oct 1989

Bibliographical note

Funding Information:
The significant mortality and morbidity rates associated with neonatal periventricular-intraventricular hemorrhage have generated interest in pharmacologic prevention trials. Indomethacin is one of the drugs under investigation. 14 However, reports on its effectiveness for prevention of PV-IVH have been conflicting. >5 Indomethacin has the advan- Supported by National Institutes of Health (National Institute of Neurological and Communicative Disorders and Stroke) Program Project grant No. USPHS NS-21405. Submitted for publication Feb. 20, 1989; accepted Apr. 28, 1989. Reprint requests: Henrietta S. Bada, MD, Newborn Center, 853 Jefferson Ave., Room 201, Memphis, TN 38163. 9/23/13601 tage of having been approved for closure of the patent ductus arteriosus, so we carried out a random-selection, double-blind clinical trial to determine its efficacy in the prevention of PV-IVH.

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health


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