Evidence map›Paper›PMID 27112038›Full record

Trial reportThe Journal of pediatrics2016

Impact of Tight Glycemic Control on Neurodevelopmental Outcomes at 1 Year of Age for Children with Congenital Heart Disease: A Randomized Controlled Trial.

Anjali Sadhwani, Lisa A Asaro, Caren Goldberg, Janice Ware, Jennifer Butcher, Michael Gaies, Cynthia Smith, Jamin L Alexander, David Wypij, Michael S D Agus

Registry-linked trialAbstract readRandomized 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 NCT00443599 (Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery), which is not on this map. Cited by 20 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
20citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

NCT00443599 nacompletednot on this map

Maintaining Normal Blood Sugar Levels in Children Undergoing Heart Surgery to Reduce the Risk of Infections and Improve Recovery (The SPECS Study)

TypeinterventionalSponsorBoston Children's HospitalRan2006 to 2014Enrolled989ConditionsHeart Defects, Congenital, HyperglycemiaArmsInsulin, Usual Care
3 · Its place in the literature

Who cites it

20 citing papers in PubMed, 4 syntheses or guidelines pooled it.

  1. Pooled it
  2. Guideline
  3. Pooled it
  4. Pooled it
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Article
  10. Article
  11. Review
  12. Observational
  13. Review
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  16. Review
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  18. Pediatric Multiple Organ Dysfunction Syndrome: Promising Therapies.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2017
    Review
  19. Optimizing nutrition of the preterm infant.Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2017
    Article
  20. 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

10 authors.

Anjali SadhwaniCardiac Neurodevelopmental Program, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston, MA. Electronic address: anjali.sadhwani@childrens.harvard.edu.
Lisa A AsaroDepartment of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Caren GoldbergDivision of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Janice WareCardiac Neurodevelopmental Program, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Psychiatry, Boston Children's Hospital and Harvard Medical School, Boston, MA.
Jennifer ButcherDepartment of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Division of Pediatric Psychology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Michael GaiesDivision of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Cynthia SmithDivision of Cardiology, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI; Department of Pediatrics and Communicable Diseases, C.S. Mott Children's Hospital and University of Michigan Medical School, Ann Arbor, MI.
Jamin L AlexanderDivision of Medicine Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA.
David WypijDepartment of Cardiology, Boston Children's Hospital and Harvard Medical School, Boston, MA; Department of Biostatistics, Harvard T.H. Chan School of Public Health, Boston, MA.
Michael S D AgusDivision of Medicine Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA.

Funding

SPECS: Safe Pediatric Euglycemia in Cardiac SurgeryR01HL088448 · NHLBI · BOSTON CHILDREN'S HOSPITAL · PI AGUS, MICHAEL SD · 2007 to 2011
$4.0M
ARRA NIH HHSNHLBI NIH HHS R01 HL088448
6 · The paper itself

Abstract

objectiveTo assess the association of postoperative tight glycemic control and hypoglycemia in children undergoing cardiac surgery with neurodevelopmental outcomes at 1 year of age. STUDY

designA 2-center, prospective, randomized trial of postoperative tight glycemic control vs standard care was conducted in 980 children undergoing cardiac surgery. Neurodevelopmental outcomes were assessed at nine to 18 months using the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III), the Adaptive Behavior Assessment System, Second Edition, the Ages and Stages Questionnaire, Third Edition, and the Brief Infant Toddler Social-Emotional Assessment.

resultsNeurodevelopmental follow-up was performed on 237 patients with a mean age of 13 months. No significant treatment group differences were found in the Bayley-III and Adaptive Behavior Assessment System, Second Edition composite scores or percentage at risk based on the Ages and Stages Questionnaire, Third Edition and the Brief Infant Toddler Social-Emotional Assessment. Patients who experienced moderate to severe hypoglycemia (n = 8) had lower Bayley-III composite scores compared with patients with no to mild hypoglycemia, even after controlling for factors known to be associated with poorer neurodevelopmental outcomes.

conclusionFor infants undergoing cardiac surgery, tight glycemic control did not impact neurodevelopmental outcomes compared with standard care. These data suggest a possible association between moderate to severe hypoglycemia and poorer neurodevelopmental outcomes at 1 year of age.

trial registrationClinicalTrials.gov: NCT00443599.

Indexed as

AlgorithmsBlood GlucoseCardiopulmonary BypassFemaleFollow-Up StudiesHeart Defects, CongenitalHumansHyperglycemiaHypoglycemiaInfantMaleNeurodevelopmental DisordersPostoperative CarePostoperative ComplicationsProspective StudiesTreatment OutcomeBlood Glucosecardiaccardiac surgeryglycemic control/blood glucosehypoglycemianeurodevelopment

Identifiers

PMID27112038
PMCPMC4925287

What OpenQuestion holds

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Read underepoch 390

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.