Evidence map›Paper›PMID 36071424›Full record

Trial reportBMC pediatrics2022

Impact of tight glycemic control and hypoglycemia after pediatric cardiac surgery on neurodevelopmental outcomes at three years of age: Findings from a randomized clinical trial.

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

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

Trial report in BMC pediatrics, 2022. 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 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 17% 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.

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

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 10 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. 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

10 authors at 4 institutions in 1 country.

Anjali SadhwaniDepartments of Psychiatry and Behavioral Sciences, Boston Children's Hospital and Harvard Medical School, 300 Longwood Ave, Boston, MA, 02115, USA. anjali.sadhwani@childrens.harvard.edu.
Lisa A AsaroDepartment of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Caren S GoldbergDivision of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Janice WareDepartment of Medicine, Boston Children's Hospital and Harvard Medical School, Boston, USA.
Jennifer ButcherDepartment of Pediatrics, University of Michigan Medical School, Ann Arbor, MI, USA.
Michael GaiesDivision of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Cynthia SmithDivision of Cardiology, C.S. Mott Children's Hospital, Ann Arbor, MI, USA.
Jamin L AlexanderDivision of Medical Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.
David WypijDepartment of Cardiology, Boston Children's Hospital, Boston, MA, USA.
Michael S D AgusDivision of Medical Critical Care, Boston Children's Hospital and Harvard Medical School, Boston, MA, USA.
Harvard University · USC. S. Mott Children's Hospital · USBoston Children's Hospital · USUniversity of Michigan–Ann Arbor · US

Funding

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

Abstract

backgroundStudies examining the impact of randomization As per standard instruction, city is required for affiliations; however, this information is missing in affiliation 6. Please check if the provided city is correct and amend if necessary. to tight glycemic control (TGC) and resultant hypoglycemia on later neurodevelopmental outcomes have produced mixed results. Our study examined this association in children undergoing cardiac surgery.

methodsParticipants who were enrolled in the Safe Pediatric Euglycemia after Cardiac Surgery (SPECS) trial returned for neurodevelopmental (ND) follow-up between 30 to 42.5 months of age. ND outcomes were assessed using the Bayley Scales of Infant and Toddler Development, Third Edition. ND scores were compared between the TGC and standard care treatment groups and between patients with moderate to severe and no to mild hypoglycemia. As a secondary analysis, to increase sample size and power, we combined the three-year-old assessments with previously collected assessments done at < 30 months of age to further examine differences between groups longitudinally.

resultsAmong the 269 participants who completed neurodevelopmental evaluation (in-person testing or questionnaires) at three years of age (follow-up rate, 31%), there were no statistically significant differences in ND outcomes according to treatment group or hypoglycemia status. In the combined analysis of all evaluations (from 9 to 42.5 months of age), we found no treatment group differences. However, in these longitudinal analyses, children who experienced moderate to severe hypoglycemia had lower scores on the Bayley-III cognitive and motor domains compared to children with no to mild hypoglycemia.

conclusionsFor infants undergoing cardiac surgery, there was no impact of tight glycemic control on neurodevelopmental outcomes. Moderate to severe hypoglycemia was associated with worse ND outcomes in longitudinal analyses.

trial registrationClinicalTrials.gov NCT00443599. Registered: November 2016.

Indexed as

Cardiac Surgical ProceduresHypoglycemiaChildChild, PreschoolGlycemic ControlHumansInfantBlood glucoseCardiac surgeryGlycemic controlHypoglycemiaNeurodevelopment

Identifiers

PMID36071424
PMCPMC9450419
OpenAlexW4294877222

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.