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.
|Number of pages||7|
|Journal||Journal of Pediatrics|
|State||Published - Oct 1989|
Bibliographical noteFunding 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