Document Detail


Feasibility study of early blood pressure management in extremely preterm infants.
MedLine Citation:
PMID:  22336574     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
OBJECTIVE: To assess the feasibility of a randomized placebo controlled trial (RCT) of blood pressure (BP) management for extremely preterm infants.
STUDY DESIGN: This was a prospective pilot RCT of infants 23-0/7 to 26-6/7 weeks gestation who had protocol-defined low BP in the first 24 postnatal hours. Enrolled infants were administered a study infusion (dopamine or placebo) and a study syringe medication (hydrocortisone or placebo).
RESULTS: Of the 366 infants screened, 119 (33%) had low BP, 58 (16%) met all entry criteria, and 10 (3%) were enrolled. A total of 161 infants (44%) were ineligible because they received early indomethacin. Only 17% of eligible infants were enrolled. Problems with consent included insufficient time, parent unavailability, and physician unwillingness to enroll critically ill infants. Two infants were withdrawn from the study because of the potential risk of intestinal perforation with simultaneous administration of hydrocortisone and indomethacin.
CONCLUSIONS: This pilot RCT was not feasible because of low eligibility and consent rates. An RCT of BP management for extremely preterm infants may require a waiver of consent for research in emergency care. The frequent use of early indomethacin and the associated risk of intestinal perforation when used with hydrocortisone may limit future investigations to only inotropic medications.
Authors:
Beau J Batton; Lei Li; Nancy S Newman; Abhik Das; Kristi L Watterberg; Bradley A Yoder; Roger G Faix; Matthew M Laughon; Krisa P Van Meurs; Waldemar A Carlo; Rosemary D Higgins; Michele C Walsh;
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Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't     Date:  2012-02-14
Journal Detail:
Title:  The Journal of pediatrics     Volume:  161     ISSN:  1097-6833     ISO Abbreviation:  J. Pediatr.     Publication Date:  2012 Jul 
Date Detail:
Created Date:  2012-06-25     Completed Date:  2012-09-10     Revised Date:  2013-07-03    
Medline Journal Info:
Nlm Unique ID:  0375410     Medline TA:  J Pediatr     Country:  United States    
Other Details:
Languages:  eng     Pagination:  65-9.e1     Citation Subset:  AIM; IM    
Copyright Information:
Copyright © 2012 Mosby, Inc. All rights reserved.
Affiliation:
Department of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA. bbatton@siumed.edu
Data Bank Information
Bank Name/Acc. No.:
ClinicalTrials.gov/NCT00874393
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MeSH Terms
Descriptor/Qualifier:
Blood Pressure*
Double-Blind Method
Feasibility Studies
Female
Gestational Age
Humans
Hypotension / therapy*
Infant, Newborn
Infant, Premature
Infant, Premature, Diseases / therapy*
Male
Pilot Projects
Prospective Studies
Grant Support
ID/Acronym/Agency:
M01 RR30/RR/NCRR NIH HHS; M01 RR32/RR/NCRR NIH HHS; M01 RR59/RR/NCRR NIH HHS; M01 RR64/RR/NCRR NIH HHS; M01 RR70/RR/NCRR NIH HHS; M01 RR80/RR/NCRR NIH HHS; M01 RR997/RR/NCRR NIH HHS; U10 HD021364-14/HD/NICHD NIH HHS; U10 HD053089/HD/NICHD NIH HHS; U10 HD21364/HD/NICHD NIH HHS; U10 HD27880/HD/NICHD NIH HHS; U10 HD34216/HD/NICHD NIH HHS; U10 HD36790/HD/NICHD NIH HHS; U10 HD40492/HD/NICHD NIH HHS; U10 HD53089/HD/NICHD NIH HHS; U10 HD53109/HD/NICHD NIH HHS; U10 HD53124/HD/NICHD NIH HHS; UL1 RR24979/RR/NCRR NIH HHS; UL1 RR25747/RR/NCRR NIH HHS; UL1 RR25764/RR/NCRR NIH HHS; UL1 TR000041/TR/NCATS NIH HHS; UL1 TR000142/TR/NCATS NIH HHS
Investigator
Investigator/Affiliation:
Michael S Caplan / ; Avroy A Fanaroff / ; Bonnie S Siner / ; Deanne E Wilson-Costello / ; Ronald N Goldberg / ; C Michael Cotten / ; Kimberley A Fisher / ; Sandy Grimes / ; Stephanie Wilson Archer / ; Dennis Wallace / ; Jeanette O'Donnell Auman / ; Margaret Cunningham / ; Carolyn M Petrie Huitema / ; James W Pickett / ; Kristin M Zaterka-Baxter / ; David K Stevenson / ; M Bethany Ball / ; Melinda S Proud / ; Namasivayam Ambalavanan / ; Monica V Collins / ; Shirley S Cosby / ; Edward F Bell / ; John A Widness / ; Jonathan M Klein / ; Karen J Johnson / ; Nancy J Krutzfield / ; Robin K Ohls / ; Conra Backstrom Lacy / ; Carl L Bose / ; Gennie Bose / ; Cindy Clark / ; Karen A Osborne / ; Jill Burnett / ; Cynthia Spencer / ; Kimberlee Weaver-Lewis / ; Karie Bird / ; Karen Zanetti / ; Laura Cole /
Comments/Corrections
Comment In:
J Pediatr. 2012 Jul;161(1):4-7   [PMID:  22484355 ]

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


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