Evidence map›Paper›PMID 37012412›Full record

Trial reportPediatric research2023

Evaluation of heterogeneity in effect of therapeutic hypothermia by sex among infants with neonatal encephalopathy.

Elizabeth K Sewell, Seetha Shankaran, Girija Natarajan, Abbot Laptook, Abhik Das, Scott A McDonald, Shannon Hamrick, Michelle Baack, Matthew Rysavy, Rosemary D Higgins and 2 more

Open access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Pediatric research, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed
7.5field-weighted citation impact, top 3% 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

10 citing papers in PubMed, 13 citations in OpenAlex.

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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

12 authors at 9 institutions in 1 country.

Elizabeth K SewellEmory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA. Elizabeth.sewell@emory.edu.
Seetha ShankaranWayne State University, Detroit, MI, USA.
Girija NatarajanWayne State University, Detroit, MI, USA.
Abbot LaptookBrown University, Providence, RI, USA.
Abhik DasRTI International, Rockville, MD, USA.
Scott A McDonaldRTI International, Research Triangle Park, NC, USA.
Shannon HamrickEmory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.
Michelle BaackUniversity of South Dakota - Sanford School of Medicine, Sioux Falls, SD, USA.
Matthew RysavyUniversity of Texas Health Science Center at Houston, Houston, TX, USA.
Rosemary D HigginsFlorida Gulf Coast University, Fort Myers, FL, USA.
Lina ChalakUniversity of Texas Southwestern, Dallas, TX, USA.
Ravi Mangal PatelEmory University School of Medicine and Children's Healthcare of Atlanta, Atlanta, GA, USA.
Emory University · USRTI International · USWayne State University · USBrown University · USChildren's Healthcare of Atlanta · USFlorida Gulf Coast University · USThe University of Texas Health Science Center at Houston · USThe University of Texas Southwestern Medical Center · USUniversity of South Dakota · US

Funding

NICHD Neonatal Research NetworkUG1HD027851 · NICHD · EMORY UNIVERSITY · PI Ravi Mangal Patel · 2016 to 2026
$3.0M
NICHD Neonatal Research NetworkUG1HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI MARON, JILL LAMANNA · 2016 to 2024
$2.1M
NICHD NIH HHS UG1 HD027851NICHD NIH HHS UG1 HD027904
6 · The paper itself

Abstract

backgroundOur objective was to examine heterogeneity in the effect of therapeutic hypothermia by sex in infants with moderate or severe neonatal encephalopathy.

methodsWe conducted a post hoc analysis of the Induced Hypothermia trial, which included infants born at gestational ages ≥36 weeks, admitted at ≤6 postnatal hours with evidence of severe acidosis or perinatal complications and moderate or severe neonatal encephalopathy. Multivariate modified Poisson regression models were used to compare the treatment effect of whole-body hypothermia versus control, with an evaluation of interaction by sex, on the primary outcome of death or moderate or severe disability at 18-22 months of corrected age.

resultsA total of 101 infants (51 male, 50 female) were randomly assigned to hypothermia treatment and 104 infants (64 male, 40 female) to control. The primary outcome occurred in 45% of the hypothermia group and 63% of the control group (RR 0.73; 95% CI 0.56, 0.94). There was no significant difference (interaction P = 0.50) in the treatment effect of hypothermia on the primary outcome between females (RR 0.79; 95% CI 0.54, 1.17) compared to males (RR 0.63; 95% CI 0.44, 0.91).

conclusionWe found no evidence that sex influences the treatment effect of hypothermia in infants with moderate or severe neonatal encephalopathy. IMPACT: Preclinical evidence suggests a differential effect in response to cooling treatment of hypoxic-ischemic injury between males and females. We found no evidence of heterogeneity in the treatment effect of whole-body hypothermia by sex in this post hoc subgroup analysis of infants with moderate or severe neonatal encephalopathy from the National Institute of Child Health and Human Development Neonatal Research Network Induced Hypothermia trial.

Indexed as

HypothermiaHypothermia, InducedHypoxia-Ischemia, BrainInfant, Newborn, DiseasesChildFemaleGestational AgeHumansInfantInfant, NewbornMalePregnancy

Identifiers

PMID37012412
PMCPMC10843889
OpenAlexW4362520758

What OpenQuestion holds

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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.