Document Detail


Timing of patent ductus arteriosus treatment and respiratory outcome in premature infants: a double-blind randomized controlled trial.
MedLine Citation:
PMID:  22284563     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To determine whether "early" ibuprofen treatment, at the onset of subtle patent ductus arteriosus (PDA) symptoms, would improve respiratory outcome in premature infants compared with "expectant" management, with ibuprofen treatment only when the PDA becomes hemodynamically significant (HS).
STUDY DESIGN: We conducted a randomized double-blind controlled trial of infants with gestational ages 23 to 32 weeks and birth weights 500 to 1250 g who had echocardiography for subtle PDA symptoms (metabolic acidosis, murmur, bounding pulses). Infants were then randomized to "early" treatment (blinded ibuprofen; n = 54) or "expectant management" (blinded placebo, n = 51). If the PDA became HS (pulmonary hemorrhage, hypotension, respiratory deterioration), infants received open label ibuprofen. Infants with HS PDA at enrollment were excluded from the study. Respiratory outcomes and mortality and major morbidities were determined.
RESULTS: "Early" treatment infants received ibuprofen at median age of 3 days; infants in the "expectant group" in whom HS symptoms developed (20%) received ibuprofen at median of 11 days. A total of 49% of "expectant" infants never required ibuprofen or ligation. No significant differences were found in the primary outcome (days on oxygen [O(2)] during the first 28 days), death, O(2) at 36 weeks, death or O(2) at 36 weeks, intestinal perforation, surgical necrotizing enterocolitis, grades III and IV intracranial hemorrhage, periventricular leukomalacia, sepsis or retinopathy of prematurity.
CONCLUSION: Infants with mild signs of PDA do not benefit from early PDA treatment compared with delayed treatment.
Authors:
Ilene R S Sosenko; M Florencia Fajardo; Nelson Claure; Eduardo Bancalari
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Publication Detail:
Type:  Comparative Study; Journal Article; Randomized Controlled Trial; Research Support, Non-U.S. Gov't     Date:  2012-01-28
Journal Detail:
Title:  The Journal of pediatrics     Volume:  160     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2012 Jun 
Date Detail:
Created Date:  2012-05-25     Completed Date:  2012-07-31     Revised Date:  2012-09-24    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  929-35.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Mosby, Inc. All rights reserved.
Affiliation:
Department of Pediatrics, University of Miami, Miami, FL, USA. isosenko@miami.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00802685
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MeSH Terms
Descriptor/Qualifier:
Cyclooxygenase Inhibitors / administration & dosage,  therapeutic use
Dose-Response Relationship, Drug
Double-Blind Method
Ductus Arteriosus, Patent / drug therapy*,  physiopathology
Female
Follow-Up Studies
Hemodynamics / drug effects
Humans
Ibuprofen / administration & dosage,  therapeutic use*
Infant, Newborn
Infant, Premature*
Male
Prospective Studies
Respiration / drug effects*
Time Factors
Treatment Outcome
Chemical
Reg. No./Substance:
0/Cyclooxygenase Inhibitors; 15687-27-1/Ibuprofen
Comments/Corrections
Comment In:
J Pediatr. 2012 Aug;161(2):370-1; author reply 371   [PMID:  22608899 ]

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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