Evidence map›Paper›PMID 28880260›Full record

Trial reportJournal of perinatology : official journal of the California Perinatal Association2017

Barriers to enrollment in a randomized controlled trial of hydrocortisone for cardiovascular insufficiency in term and late preterm newborn infants.

K L Watterberg, E Fernandez, M C Walsh, W E Truog, B J Stoll, G M Sokol, K A Kennedy, M V Fraga, S S Beauman, B Carper and 16 more

Open access · greenAbstract readMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of perinatology : official journal of the California Perinatal Association, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
1.0field-weighted citation impact, top 21% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 16 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Hypotension in Preterm Infants (HIP) randomised trial.Archives of disease in childhood. Fetal and neonatal edition · 2021
    Trial
  4. Review
  5. Review
  6. Review
  7. Article
  8. Article
  9. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

26 authors at 20 institutions in 1 country.

K L WatterbergDepartment of Pediatrics/Neonatology, Children's Hospital of New Mexico, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
E FernandezDepartment of Pediatrics/Neonatology, Children's Hospital of New Mexico, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
M C WalshDepartment of Pediatrics, Rainbow Babies & Children's Hospital, Case Western Reserve University, Cleveland, OH, USA.
W E TruogDepartment of Pediatrics, Children's Mercy Hospital, Kansas City, MO, USA.
B J StollDepartment of Pediatrics, Emory University School of Medicine, Children's Healthcare of Atlanta, Atlanta, GA, USA.
G M SokolDepartment of Pediatrics, Indiana University School of Medicine, Indianapolis, IN, USA.
K A KennedyDepartment of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.
M V FragaDepartment of Pediatrics, The Children's Hospital of Philadelphia and The University of Pennsylvania, Philadelphia, PA, USA.
S S BeaumanDepartment of Pediatrics/Neonatology, Children's Hospital of New Mexico, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
B CarperSocial, Statistical and Environmental Sciences Unit, RTI International, Research Triangle Park, NC, USA.ORCID 0000-0001-5882-2232
A DasSocial, Statistical and Environmental Sciences Unit, RTI International, Rockville, MD, USA.
A F DuncanDepartment of Pediatrics, McGovern Medical School at The University of Texas Health Science Center at Houston, Houston, TX, USA.
W F BussDepartment of Pharmacy, Indiana University Health, Indianapolis, IN, USA.
C GauldinDepartment of Pediatrics, Children's Mercy Hospital, Kansas City, MO, USA.
C B LacyDepartment of Pediatrics/Neonatology, Children's Hospital of New Mexico, University of New Mexico Health Sciences Center, Albuquerque, NM, USA.
P J SanchezDepartment of Pediatrics, Nationwide Children's Hospital, Columbus, OH, USA.
S ChawlaDepartment of Pediatrics, Wayne State University, Detroit, MI, USA.
S LakshminrusimhaDepartment of Pediatrics, University of Buffalo Women's and Children's Hospital of Buffalo, Buffalo, NY, USA.
C M CottenDepartment of Pediatrics, Duke University, Durham, NC, USA.
K P Van MeursDepartment of Pediatrics, Division of Neonatal and Developmental Medicine, Stanford University School of Medicine and Lucile Packard Children's Hospital, Palo Alto, CA, USA.
B B PoindexterPerinatal Institute, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
E F BellDepartment of Pediatrics, University of Iowa, Iowa City, IA, USA.
W A CarloDivision of Neonatology, University of Alabama at Birmingham, Birmingham, AL, USA.
U DevaskarDepartment of Pediatrics, University of California, Los Angeles, CA, USA.
M H WyckoffDepartment of Pediatrics, University of Texas Southwestern Medical Center, Dallas, TX, USA.
R D HigginsEunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, Bethesda, MD, USA.
UNM Children's Hospital · USChildren's Mercy Hospital · USRTI International · USThe University of Texas Health Science Center at Houston · USChildren's Hospital of Philadelphia · USCincinnati Children's Hospital Medical Center · USDuke University · USEmory University · USIndiana University Health · USIndiana University School of MedicineLucile Packard Children's Hospital · USNational Institutes of Health · USNationwide Children's Hospital · USRainbow Babies & Children's Hospital · USThe University of Texas Southwestern Medical Center · USUniversity of Alabama at Birmingham · USUniversity of California, Los Angeles · USUniversity of Iowa · USWayne State University · USWomen & Children's Hospital of Buffalo · US

Funding

Data Ctr for the Cooperative Neonatal Research NetworkU01HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 1998 to 2007
$21.8M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021385 · NICHD · WAYNE STATE UNIVERSITY · PI SHANKARAN, SEETHA · 1991 to 2015
$8.7M
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 NetworkU10HD021373 · NICHD · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI KENNEDY, KATHLEEN A · 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 NetworkU10HD027856 · NICHD · INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS · PI SOKOL, GREGORY M. · 1991 to 2015
$5.9M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD040689 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI WYCKOFF, MYRA HELEN · 2001 to 2015
$5.6M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD040492 · NICHD · DUKE UNIVERSITY · PI COTTEN, CHARLES MICHAEL · 2001 to 2015
$5.4M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD027851 · NICHD · EMORY UNIVERSITY · PI CARLTON, DAVID · 1991 to 2015
$5.0M
NICHD Neonatal Research Network -- Cincinnati Clinical CenterUG1HD027853 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI STEPHANIE L MERHAR · 2016 to 2026
$3.7M
NICHD COPPERATIVE MULTICENTER NEONATAL RESEARCH NETWORKUG1HD040689 · NICHD · UT SOUTHWESTERN MEDICAL CENTER · PI Myra Helen Wyckoff · 2016 to 2026
$3.5M
NICHD NIH HHS U01 HD036790NICHD NIH HHS U10 HD021364NICHD NIH HHS U10 HD021373NICHD NIH HHS U10 HD021385NICHD NIH HHS U10 HD027851NICHD NIH HHS U10 HD027856NICHD NIH HHS U10 HD027880NICHD NIH HHS U10 HD034216NICHD NIH HHS U10 HD040492NICHD NIH HHS U10 HD040689NICHD NIH HHS U10 HD053089NICHD NIH HHS U10 HD053109NICHD NIH HHS U10 HD068244NICHD NIH HHS U10 HD068263NICHD NIH HHS U10 HD068270NICHD NIH HHS U10 HD068278NICHD NIH HHS U10 HD068284NICHD NIH HHS UG1 HD021364NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD027856NICHD NIH HHS UG1 HD027880NICHD NIH HHS UG1 HD034216NICHD NIH HHS UG1 HD040492NICHD NIH HHS UG1 HD040689NICHD NIH HHS UG1 HD053089NICHD NIH HHS UG1 HD053109NICHD NIH HHS UG1 HD068263NICHD NIH HHS UG1 HD068270NICHD NIH HHS UG1 HD068278
6 · The paper itself

Abstract

objectiveTo analyze reasons for low enrollment in a randomized controlled trial (RCT) of the effect of hydrocortisone for cardiovascular insufficiency on survival without neurodevelopmental impairment (NDI) in term/late preterm newborns. STUDY

designThe original study was a multicenter RCT. Eligibility: ⩾34 weeks' gestation, <72 h old, mechanically ventilated, receiving inotrope. Primary outcome was NDI at 2 years; infants with diagnoses at high risk for NDI were excluded. This paper presents an analysis of reasons for low patient enrollment.

resultsTwo hundred and fifty-seven of the 932 otherwise eligible infants received inotropes; however, 207 (81%) had exclusionary diagnoses. Only 12 infants were randomized over 10 months; therefore, the study was terminated. Contributing factors included few eligible infants after exclusions, open-label steroid therapy and a narrow enrollment window.

conclusionDespite an observational study to estimate the population, very few infants were enrolled. Successful RCTs of emergent therapy may require fewer exclusions, a short-term primary outcome, waiver of consent and/or other alternatives.

Indexed as

Patient SelectionCardiotonic AgentsCritical IllnessDouble-Blind MethodEarly Termination of Clinical TrialsHeart Defects, CongenitalHeart FailureHumansHydrocortisoneInfant, NewbornInfant, PrematureInformed ConsentNeurodevelopmental DisordersCardiotonic AgentsHydrocortisone

Identifiers

PMID28880260
PMCPMC5688018
OpenAlexW2752419646

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.