Indomethacin reduces the risks of severe intraventricular hemorrhage

• Published in: The Journal of pediatrics Vol. 115; no. 4; p. 631
• Main Authors: Bada, H S, Green, R S, Pourcyrous, M, Leffler, C W, Korones, S B, Magill, H L, Arheart, K, Fitch, C W, Anderson, G D, Somes, G
• Format: Journal Article
• Language: English
• Published: United States 01-10-1989
• Subjects: Apgar Score; Birth Weight; Cerebral Hemorrhage - prevention & control; Clinical Trials as Topic; Double-Blind Method; Female; Humans; Indomethacin - therapeutic use; Infant, Newborn; Logistic Models; Male; Prospective Studies; Random Allocation; Risk Factors; Sex Factors
• ISSN: 0022-3476
• DOI: 10.1016/S0022-3476(89)80300-2

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 less than or equal to 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 greater than 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 less than 0.03). The incidence of severe PV-IVH was 3% in the indomethacin-treated babies and 14% in the control group (p less than 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 11.25:1 and 9:1, 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.