Evidence map›Paper›PMID 22336574›Full record

Trial reportThe Journal of pediatrics2012

Feasibility study of early blood pressure management in extremely preterm infants.

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 and 3 more

Registry-linked trialOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00874393 (Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study), which is not on this map. Cited by 27 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
27citing papers in PubMed, 9 pooled it
3.7field-weighted citation impact, top 7% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00874393 phase1completednot on this map

Early Blood Pressure Management in Extremely Preterm Infants Feasibility Pilot Study

TypeinterventionalSponsorNICHD Neonatal Research NetworkRan2009 to 2011Enrolled10ConditionsInfant, Newborn, Infant, Low Birth Weight, Infant, Small for Gestational Age, Infant, PrematureArmsDopamine, Hydrocortisone, Infusion Placebo, Syringe Placebo
3 · Its place in the literature

Who cites it

27 citing papers in PubMed, 9 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  10. Hypotension in Preterm Infants (HIP) randomised trial.Archives of disease in childhood. Fetal and neonatal edition · 2021
    Trial
  11. Trial
  12. Article
  13. Review
  14. Review
  15. Review
  16. Article
  17. Review
  18. Vasoactive medications in extremely low gestational age neonates during the first postnatal week.Journal of perinatology : official journal of the California Perinatal Association · 2021
    Article
  19. Article
  20. Article
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

13 authors at 10 institutions in 2 countries.

Beau J BattonDepartment of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA. bbatton@siumed.edu
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
Eunice Kennedy Shriver National Institute of Child Health and Human Development Neonatal Research Network
Rainbow Babies & Children's Hospital · USUniversity of Utah · USCase Western Reserve University · USEunice Kennedy Shriver National Institute of Child Health and Human Development · USMRC Epidemiology Unit · GBRTI International · USStanford University · USUniversity of Alabama at Birmingham · USUniversity of New Mexico · USUniversity of North Carolina at Chapel Hill · US

Funding

Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
UNC CLINICAL AND TRANSLATIONAL SCIENCE AWARD: BPCAUL1RR025747 · NCRR · UNIV OF NORTH CAROLINA CHAPEL HILL · PI RUNGE, MARSCHALL S. · 2008 to 2011
$44.6M
UNM HSC Clinical and Translational Science CenterUL1TR001449 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI CAMPEN, MATTHEW J, PANDHI, NANCY · 2015 to 2024
$36.9M
UNIVERSITY OF IOWA CTSA FOR PEDIATRIC RESEARCHUL1RR024979 · NCRR · UNIVERSITY OF IOWA · PI ROSENTHAL, GARY E · 2007 to 2011
$31.8M
UNIVERSITY OF UTAH CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCE-UL1: BPCAUL1RR025764 · NCRR · UNIVERSITY OF UTAH · PI MCCLAIN, DONALD A. · 2008 to 2011
$19.4M
University of New Mexico Clinical and Translational Science CenterUL1TR000041 · NCATS · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI LARSON, RICHARD S · 2012 to 2014
$9.8M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD034216 · NICHD · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI CARLO FONT, WALDEMAR A. · 1996 to 2015
$6.4M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027880 · NICHD · STANFORD UNIVERSITY · PI VAN MEURS, KRISA PAGE · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021364 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI WALSH, MICHELE · 1991 to 2015
$6.1M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD040492 · NICHD · DUKE UNIVERSITY · PI COTTEN, CHARLES MICHAEL · 2001 to 2015
$5.4M
NICHD Neonatal Research Network Clinical Center - Case Western Reserve UniversityUG1HD021364 · NICHD · CASE WESTERN RESERVE UNIVERSITY · PI Anna Maria Hibbs · 2016 to 2026
$3.5M
Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetworkUG1HD053089 · NICHD · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Janell Fuller, Jessie R. Maxwell · 2016 to 2026
$3.2M
NCATS NIH HHS UL1 TR000041NCATS NIH HHS UL1 TR001449NCRR NIH HHS M01 RR30NCRR NIH HHS M01 RR32NCRR NIH HHS M01 RR59NCRR NIH HHS M01 RR64NCRR NIH HHS M01 RR70NCRR NIH HHS M01 RR80NCRR NIH HHS M01 RR997NCRR NIH HHS UL1 RR024979NCRR NIH HHS UL1 RR24979NCRR NIH HHS UL1 RR25747NCRR NIH HHS UL1 RR25764NICHD NIH HHS U10 HD021364NICHD NIH HHS U10 HD053089NICHD NIH HHS U10 HD21364NICHD NIH HHS U10 HD27880NICHD NIH HHS U10 HD34216NICHD NIH HHS U10 HD36790NICHD NIH HHS U10 HD40492NICHD NIH HHS U10 HD53089NICHD NIH HHS U10 HD53109NICHD NIH HHS U10 HD53124NICHD NIH HHS UG1 HD021364NICHD NIH HHS UG1 HD053089
6 · The paper itself

Abstract

objectiveTo assess the feasibility of a randomized placebo controlled trial (RCT) of blood pressure (BP) management for extremely preterm infants. STUDY

designThis 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).

resultsOf 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.

conclusionsThis 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.

Indexed as

Blood PressureDouble-Blind MethodFeasibility StudiesFemaleGestational AgeHumansHypotensionInfant, NewbornInfant, PrematureInfant, Premature, DiseasesMalePilot ProjectsProspective Studies

Identifiers

PMID22336574
PMCPMC3357442
OpenAlexW2044526471

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.