Evidence map›Paper›PMID 26490132›Full record

Trial reportThe Journal of pediatrics2016

Growth Asymmetry, Head Circumference, and Neurodevelopmental Outcomes in Infants with Single Ventricles.

Thomas A Miller, Victor Zak, Peter Shrader, Chitra Ravishankar, Victoria L Pemberton, Jane W Newburger, Amanda J Shillingford, Nicholas Dagincourt, James F Cnota, Linda M Lambert and 7 more

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

Trial report in The Journal of pediatrics, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00113087 (Trial of ACE Inhibition in Infants With Single Ventricle), which is not on this map. Cited by 14 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 1 pooled it
1.7field-weighted citation impact, top 15% 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.

NCT00113087 phase3completednot on this map

Trial of ACE Inhibition in Infants With Single Ventricle (A Trial Conducted by the Pediatric Heart Network)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)Ran2003 to 2008Enrolled230ConditionsHeart Defects, Congenital, Heart Failure, CongestiveArmsEnalapril, Placebo
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 1 synthesis or guideline pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Article
  4. Article
  5. Article
  6. Observational
  7. Article
  8. Article
  9. Article
  10. Chronic intrauterine hypoxia alters neurodevelopment in fetal sheep.The Journal of thoracic and cardiovascular surgery · 2019
    Article
  11. Article
  12. Growth in Congenital Heart Disease: Outcome or Predictor?Journal of the American Heart Association · 2018
    Article
  13. Review
  14. Article
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

17 authors at 15 institutions in 2 countries.

Thomas A MillerDepartment of Pediatrics, University of Utah, Salt Lake City, UT. Electronic address: thomas.a.miller@hsc.utah.edu.
Victor ZakNew England Research Institute, Watertown, MA.
Peter ShraderNew England Research Institute, Watertown, MA.
Chitra RavishankarDepartment of Pediatrics, Children's Hospital of Philadelphia, Philadelphia, PA.
Victoria L PembertonNational Heart, Lung, and Blood Institute, National Institutes of Health, Bethesda, MD.
Jane W NewburgerDepartment of Cardiology, Boston Children's Hospital, and Department of Pediatrics, Harvard Medical School, Boston, MA.
Amanda J ShillingfordDepartment of Pediatrics, Children's Hospital of Wisconsin, Milwaukee, WI.
Nicholas DagincourtNew England Research Institute, Watertown, MA.
James F CnotaDepartment of Pediatrics, Cincinnati Children's Hospital Medical Center, Cincinnati, OH.
Linda M LambertDepartment of Surgery, University of Utah, Salt Lake City, UT.
Renee SananesDepartment of Pediatrics, Hospital for Sick Children, Toronto, Ontario, Canada.
Marc E RichmondDepartment of Pediatrics, Columbia University Medical Center, New York, NY.
Daphne T HsuDepartment of Pediatrics, Children's Hospital at Montefiore/Albert Einstein College of Medicine, New York, NY.
Stephen G MillerDepartment of Pediatrics, Duke University Medical Center, Durham, NC.
Sinai C ZyblewskiDepartment of Pediatrics, Medical University of South Carolina, Charleston, SC.
Richard V WilliamsDepartment of Pediatrics, University of Utah, Salt Lake City, UT.
Pediatric Heart Network Investigators
New England Research (United States) · USUniversity of Utah · USChildren's Hospital of Philadelphia · USChildren's Hospital of Wisconsin · USCincinnati Children's Hospital Medical Center · USColumbia University Irving Medical Center · USDuke Medical Center · USHospital for Sick Children · CAMedical University of South Carolina · USAlbert Einstein College of Medicine · USBoston Children's Hospital · USChildren's Hospital at Montefiore · USHarvard University · USNational Heart Lung and Blood Institute · USNational Institutes of Health · US

Funding

Pediatric Heart network DCCU10HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI MILLER, JULIE ELAINE, TRACHTENBERG, FELICIA LYNN · 2011 to 2016
$44.9M
Ventricular Volumes and Varability (VVV)U01HL068270 · NHLBI · NEW ENGLAND RESEARCH INSTITUTES, INC. · PI SLEEPER, LYNN A · 2001 to 2010
$40.3M
Mouse Neurodevelopmental Behavior CoreU54HD090255 · NICHD · BOSTON CHILDREN'S HOSPITAL · PI POMEROY, SCOTT LOREN · 2016 to 2020
$5.2M
Pediatric Heart Network: Follow-up of the Single Ventricle Reconstruction TrialU01HL068290 · NHLBI · COLUMBIA UNIVERSITY HEALTH SCIENCES · PI LAI, WYMAN W · 2001 to 2010
$4.1M
Pediatric Heart Disease Network: CHOP MembershipU01HL068279 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI VETTER, VICTORIA L · 2001 to 2010
$3.7M
Randomized Therapeutic Trials in Pediatric Heart DiseaseU01HL068285 · NHLBI · CHILDREN'S HOSPITAL BOSTON · PI NEWBURGER, JANE W. · 2001 to 2010
$3.4M
Randomized Clinical Trials for Pediatric Heart DiseaseU01HL068281 · NHLBI · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI SAUL, J PHILIP · 2001 to 2010
$3.2M
Clinical and genomic responses to remote ischemic preconditioningU01HL068288 · NHLBI · HOSPITAL FOR SICK CHLDRN (TORONTO) · PI MCCRINDLE, BRIAN W · 2001 to 2010
$3.0M
Intermountain Pediatric Heart Disease Research CenterU01HL068292 · NHLBI · UNIVERSITY OF UTAH · PI MINICH, L. LUANN · 2001 to 2010
$2.7M
The Duke-UNC-CH Pediatric Cardiology Clinical CenterU01HL068269 · NHLBI · DUKE UNIVERSITY · PI LI, JENNIFER S · 2001 to 2010
$2.6M
Pediatric Heart Network Prairieland ConsortiumU10HL109673 · NHLBI · CINCINNATI CHILDRENS HOSP MED CTR · PI CNOTA, JAMES, PAYNE, RONALD MARK · 2011 to 2015
$2.3M
Pediatric Heart Network Regents of the University of MichiganU10HL109737 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI GOLDBERG, CAREN S, OHYE, RICHARD G · 2011 to 2015
$2.3M
NHLBI NIH HHS HL068269NHLBI NIH HHS HL068270NHLBI NIH HHS HL068279NHLBI NIH HHS HL068281NHLBI NIH HHS HL068285NHLBI NIH HHS HL068288NHLBI NIH HHS HL068290NHLBI NIH HHS HL068292NHLBI NIH HHS HL085057NHLBI NIH HHS HL109737NHLBI NIH HHS HL109781NHLBI NIH HHS U01 HL068269NHLBI NIH HHS U01 HL068270NHLBI NIH HHS U01 HL068279NHLBI NIH HHS U01 HL068281NHLBI NIH HHS U01 HL068285NHLBI NIH HHS U01 HL068288NHLBI NIH HHS U01 HL068290NHLBI NIH HHS U01 HL068292NHLBI NIH HHS U01 HL085057NHLBI NIH HHS U10 HL068270NHLBI NIH HHS U10 HL109673NHLBI NIH HHS U10 HL109737NHLBI NIH HHS U10 HL109743NHLBI NIH HHS U10 HL109781NICHD NIH HHS U54 HD090255
6 · The paper itself

Abstract

objectiveTo assess the variability in asymmetric growth and its association with neurodevelopment in infants with single ventricle (SV). STUDY

designWe analyzed weight-for-age z-score minus head circumference-for-age z-score (HCAZ), relative head growth (cm/kg), along with individual growth variables in subjects prospectively enrolled in the Infant Single Ventricle Trial. Associations between growth indices and scores on the Psychomotor Developmental Index (PDI) and Mental Developmental Index (MDI) of the Bayley Scales of Infant Development-II (BSID-II) at 14 months were assessed.

resultsOf the 230 subjects enrolled in the Infant Single Ventricle trial, complete growth data and BSID-II scores were available in 168 (73%). Across the cohort, indices of asymmetric growth varied widely at enrollment and before superior cavopulmonary connection (SCPC) surgery. BSID-II scores were not associated with these asymmetry indices. In bivariate analyses, greater pre-SCPC HCAZ correlated with higher MDI (r = 0.21; P = .006) and PDI (r = 0.38; P < .001) and a greater HCAZ increase from enrollment to pre-SCPC with higher PDI (r = 0.15; P = .049). In multivariable modeling, pre-SCPC HCAZ was an independent predictor of PDI (P = .03), but not MDI.

conclusionIn infants with SV, growth asymmetry was not associated with neurodevelopment at 14 months, but pre-SCPC HCAZ was associated with PDI. Asymmetric growth, important in other high-risk infants, is not a brain-sparing adaptation in infants with SV.

trial registrationClinicaltrials.gov: NCT00113087.

Indexed as

CephalometryAngiotensin-Converting Enzyme InhibitorsCardiovascular AbnormalitiesDouble-Blind MethodEnalaprilFemaleGrowth DisordersHeart Defects, CongenitalHeart VentriclesHumansInfantInfant, NewbornMaleNeurodevelopmental DisordersProspective StudiesAngiotensin-Converting Enzyme InhibitorsEnalapril

Identifiers

PMID26490132
PMCPMC4698012
OpenAlexW2179975033

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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.