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Randomized Controlled Trial
. 2011 Jul;165(7):642-6.
doi: 10.1001/archpediatrics.2011.95.

Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids

Barbara Schmidt  1 , Mary Seshia, Seetha Shankaran, Lindsay Mildenhall, Jon Tyson, Kei Lui, Tai Fok, Robin Roberts; Trial of Indomethacin Prophylaxis in Preterms Investigators
Collaborators, Affiliations
Randomized Controlled Trial

Effects of prophylactic indomethacin in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids

Barbara Schmidt et al. Arch Pediatr Adolesc Med. 2011 Jul.

Abstract

Objective: To examine whether treatment with antenatal corticosteroids modifies the immediate and long-term effects of prophylactic indomethacin sodium trihydrate in extremely low-birth-weight infants.

Design: Post hoc subgroup analysis of data from the Trial of Indomethacin Prophylaxis in Preterms.

Setting: Thirty-two neonatal intensive care units in Canada, the United States, Australia, New Zealand, and Hong Kong.

Participants: A total of 1195 infants with birth weights of 500 to 999 g and known exposure to antenatal corticosteroids. We defined as adequate any exposure to antenatal corticosteroids that occurred at least 24 hours before delivery.

Intervention: Indomethacin or placebo intravenously once daily for the first 3 days.

Outcome measures: Death or survival to 18 months with cerebral palsy, cognitive delay, severe hearing loss, or bilateral blindness; severe periventricular and intraventricular hemorrhage; patent ductus arteriosus; and surgical closure of a patent ductus arteriosus.

Results: Of the 1195 infants in this analysis cohort, 670 had adequate and 525 had inadequate exposure to antenatal corticosteroids. There was little statistical evidence of heterogeneity in the effects of prophylactic indomethacin between the subgroups for any of the outcomes. The adjusted P values for interaction were as low as .15 for the outcome of death or impairment at 18 months and as high as .80 for the outcome of surgical duct closure.

Conclusion: We find little evidence that the effects of prophylactic indomethacin vary in extremely low-birth-weight infants with and without adequate exposure to antenatal corticosteroids. Trial Registration clinicaltrials.gov Identifier: NCT00009646.

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References

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