D A Osborn1, N Evans, M Kluckow. 1. Department of Neonatal Medicine, Royal Prince Alfred Hospital and University of Sydney, Sydney, NSW, Australia. david.osborn@email.cs.nsw.gov.au
Abstract
OBJECTIVE: To determine if indomethacin given to preterm infants with a large ductus arteriosus (DA) in the first hours of life results in maintained or improved brain and upper body blood (superior vena cava (SVC)) flow. STUDY DESIGN: A randomised, double blind trial of indomethacin v placebo. Echocardiography was performed on 111 infants born at < 30 weeks gestation at 3 and/or 10 hours after birth. Infants were eligible if the DA diameter was > 1.6 mm. Infants were randomised to receive indomethacin 0.2 mg/kg or placebo. Crossover occurred if the DA was still > 1.6 mm. Echocardiography was performed one hour after each treatment. RESULTS:Seventy (63%) infants had a DA > 1.6 mm, with 35 randomised to receive indomethacin and 35 to receive placebo. At one hour there was no difference in DA constriction (indomethacin -20% v placebo -15%), change in SVC flow (-1% v -9%), for right ventricular output (RVO). Two hours after indomethacin, 62 infants had uncontrolled observations, at which time significant ductal constriction had occurred. At this time, infants of > or = 27 weeks gestation had significantly greater increases in SVC flow and RVO than infants of < 27 weeks gestation. Infants with failed ductal constriction had significantly lower initial SVC flow and developed more late grade 3/4 peri/intraventricular haemorrhage (P/IVH). Initial SVC flow, but not ductal constriction, was a significant predictor of late grade 3/4 P/IVH in adjusted analysis. CONCLUSIONS:Indomethacin had minimal effect on ductal constriction and blood flow at one hour compared with placebo. Failure of ductal constriction is associated with low SVC flow and subsequent late severe P/IVH.
RCT Entities:
OBJECTIVE: To determine if indomethacin given to preterm infants with a large ductus arteriosus (DA) in the first hours of life results in maintained or improved brain and upper body blood (superior vena cava (SVC)) flow. STUDY DESIGN: A randomised, double blind trial of indomethacin v placebo. Echocardiography was performed on 111 infants born at < 30 weeks gestation at 3 and/or 10 hours after birth. Infants were eligible if the DA diameter was > 1.6 mm. Infants were randomised to receive indomethacin 0.2 mg/kg or placebo. Crossover occurred if the DA was still > 1.6 mm. Echocardiography was performed one hour after each treatment. RESULTS: Seventy (63%) infants had a DA > 1.6 mm, with 35 randomised to receive indomethacin and 35 to receive placebo. At one hour there was no difference in DA constriction (indomethacin -20% v placebo -15%), change in SVC flow (-1% v -9%), for right ventricular output (RVO). Two hours after indomethacin, 62 infants had uncontrolled observations, at which time significant ductal constriction had occurred. At this time, infants of > or = 27 weeks gestation had significantly greater increases in SVC flow and RVO than infants of < 27 weeks gestation. Infants with failed ductal constriction had significantly lower initial SVC flow and developed more late grade 3/4 peri/intraventricular haemorrhage (P/IVH). Initial SVC flow, but not ductal constriction, was a significant predictor of late grade 3/4 P/IVH in adjusted analysis. CONCLUSIONS:Indomethacin had minimal effect on ductal constriction and blood flow at one hour compared with placebo. Failure of ductal constriction is associated with low SVC flow and subsequent late severe P/IVH.
Authors: B R Vohr; L L Wright; A M Dusick; L Mele; J Verter; J J Steichen; N P Simon; D C Wilson; S Broyles; C R Bauer; V Delaney-Black; K A Yolton; B E Fleisher; L A Papile; M D Kaplan Journal: Pediatrics Date: 2000-06 Impact factor: 7.124
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Authors: Joe Brierley; Joseph A Carcillo; Karen Choong; Tim Cornell; Allan Decaen; Andreas Deymann; Allan Doctor; Alan Davis; John Duff; Marc-Andre Dugas; Alan Duncan; Barry Evans; Jonathan Feldman; Kathryn Felmet; Gene Fisher; Lorry Frankel; Howard Jeffries; Bruce Greenwald; Juan Gutierrez; Mark Hall; Yong Y Han; James Hanson; Jan Hazelzet; Lynn Hernan; Jane Kiff; Niranjan Kissoon; Alexander Kon; Jose Irazuzta; Jose Irazusta; John Lin; Angie Lorts; Michelle Mariscalco; Renuka Mehta; Simon Nadel; Trung Nguyen; Carol Nicholson; Mark Peters; Regina Okhuysen-Cawley; Tom Poulton; Monica Relves; Agustin Rodriguez; Ranna Rozenfeld; Eduardo Schnitzler; Tom Shanley; Saraswati Kache; Sara Skache; Peter Skippen; Adalberto Torres; Bettina von Dessauer; Jacki Weingarten; Timothy Yeh; Arno Zaritsky; Bonnie Stojadinovic; Jerry Zimmerman; Aaron Zuckerberg Journal: Crit Care Med Date: 2009-02 Impact factor: 7.598