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Cited by 385Neonatal and fetal brain pathologyCardiovascular Conditions and TreatmentsInfant Development and Preterm Care

Low‐dose indomethacin and prevention of intraventricular hemorrhage: A multicenter randomized trial

Ment, Laura R., Ehrenkranz, Richard A., Duncan, Charles C., Scott, David T., Taylor, Kenneth J.W., Katz, Karol H., Schneider, Karen C., Makuch, Robert W. +4 more·1994·Pediatrics
DOI 10.1542/peds.93.4.543
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Abstract

OBJECTIVES: Parenchymal involvement of intraventricular hemorrhage (IVH) is a major risk factor for neurodevelopmental handicap in very low birth weight neonates. Previous trials have suggested that indomethacin would lower the incidence and severity of IVH in very low birth weight neonates. METHODS: We enrolled 431 neonates of 600- to 1250-g birth weight with no evidence for IVH at 6 to 11 hours of age in a prospective, randomized, placebo-controlled trial to test the hypothesis that low-dose indomethacin (0.1 mg/kg intravenously at 6 to 12 postnatal hours and every 24 hours for two more doses) would lower the incidence and severity of IVH. Serial cranial ultrasound examinations and echocardiographs were performed. RESULTS: There were no differences in the birth weight, gestational age, sex, Apgar scores, and percent of neonates treated with surfactant between the indomethacin and placebo groups. Within the first 5 days, 25 (12%) indomethacin-treated and 40 (18%) placebo-treated neonates developed IVH (P = .03, trend test). Only one indomethacin-treated patient experienced grade 4 IVH compared with 10 placebo-treated neonates (P = .01). Sixteen indomethacin-treated neonates and 29 control neonates died (P = .08); there was a difference favoring indomethacin with respect to survival time (P = .06). Eighty-six percent of all neonates had a patent ductus arteriosus on the first postnatal day; indomethacin was associated with significant ductal closure by the fifth day of life (P < .001). There were no differences in adverse events attributed to indomethacin between the two treatment groups. CONCLUSIONS: Low-dose prophylactic indomethacin significantly lowers the incidence and severity of IVH, particularly the severe form (grade 4 IVH). In addition, indomethacin closes the patent ductus arteriosus and is not associated with significant adverse drug events in very low birth weight neonates.

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  • Earlier trials of nonselective COX inhibitors reduced severe intraventricular hemorrhage, but those trials lacked power or design to assess NWMI.

    “Previous studies using nonspecific COX inhibitors, such as indomethacin or ibuprofen, to promote patent ductus arteriosus (PDA) closure in preterm infants showed benefit for the prevention of severe intraventricular hemorrhage (Ment et al., 1994; Schmidt et al., 2001) but they were not powered or designed to evaluate NWMI.”

    From Reactive astrocyte COX2-PGE2 production inhibits oligodendrocyte maturation in neonatal white matter injury (2017) · cites this paper as Ment et al., 1994

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Authors
Ment, L. R., Ehrenkranz, R. A., Duncan, C. C., Scott, D. T., Taylor, K. J. W., Katz, K. H., Schneider, K. C., Makuch, R. W., Oh, W., Vohr, B., Philip, A. G. S., & Allan, W.
Affiliations
Yale University (US)
ORCID
Venue
Pediatrics
Publisher
American Academy of Pediatrics (AAP)
Published
1994-04-01
Volume
93
Issue
4
Pages
543-550
ISSN
  • 0031-4005 (ISSN-L)
  • 1098-4275
DOI
10.1542/peds.93.4.543
OpenAlex
W2149974774
Cited by
385
References
0
Citations by year
2026: 5 · 2025: 4 · 2024: 3 · 2023: 8 · 2022: 14 · 2021: 13 · 2020: 9 · 2019: 9 · 2018: 8 · 2017: 10 · 2016: 10 · 2015: 3 · 2014: 10 · 2013: 9 · 2012: 21
FWCI
20.56
Type
journal article
Language
en
Open access
closed
Locations
  • PEDIATRICS (publishedVersion)
  • PubMed (publishedVersion)
Funders
  • National Institute of Neurological Disorders and Stroke (NS-27116, R01NS027116)
  • National Center for Research Resources (RR06022)
Topics
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Neonatal and fetal brain pathology
  • Health Sciences › Medicine › Radiology, Nuclear Medicine and Imaging › Cardiovascular Conditions and Treatments
  • Health Sciences › Medicine › Pediatrics, Perinatology and Child Health › Infant Development and Preterm Care
Keywords
indomethacin, intraventricular hemorrhage, very low birth weight infants, prophylaxis, patent ductus arteriosus, ductus arteriosus closure, neonatal survival, adverse drug reactions, nonsteroidal anti-inflammatory drugs
MeSH terms
Cerebral Hemorrhage, Ductus Arteriosus, Patent, Female, Humans, Indomethacin, Infant, Low Birth Weight, Infant, Newborn, Infant, Premature, Male, Prospective Studies, Regression Analysis, Treatment Outcome

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