Evidence map›Paper›PMID 22271697›Full record

ArticlePediatrics2012

Perioperative methylprednisolone and outcome in neonates undergoing heart surgery.

Sara K Pasquali, Jennifer S Li, Xia He, Marshall L Jacobs, Sean M O'Brien, Matthew Hall, Robert D B Jaquiss, Karl F Welke, Eric D Peterson, Samir S Shah and 2 more

2 registry-linked trialsOpen access · greenAbstract readComparative StudyMulticenter Study
In one paragraph

Article in Pediatrics, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 43 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
43citing papers in PubMed, 5 pooled it
8.5field-weighted citation impact, top 2% 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.

NCT01579513 nacompletednot on this map

Corticosteroid Therapy in Neonates Undergoing Cardiopulmonary Bypass

TypeinterventionalSponsorMedical University of South CarolinaRan2012 to 2018Enrolled190ConditionsCongenital Heart Disease, Disorder of Fetus or NewbornArmsMethylprednisolone, Placebo
NCT03229538 phase3completednot on this mapstarted 2017, after this paper: background citation

STeroids to REduce Systemic Inflammation After Infant Heart Surgery (STRESS)

TypeinterventionalSponsorKevin HillRan2017 to 2022Enrolled1,263ConditionsCongenital Heart Disease in Children, Inflammatory ResponseArmsMethylprednisolone, Isotonic saline
3 · Its place in the literature

Who cites it

43 citing papers in PubMed, 5 syntheses or guidelines pooled it, 110 citations in OpenAlex.

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  9. Intraoperative Steroid Use and Outcomes Following the Norwood Procedure: An Analysis of the Pediatric Heart Network's Public Database.Pediatric critical care medicine : a journal of the Society of Critical Care Medicine and the World Federation of Pediatric Intensive and Critical Care Societies · 2016
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  18. Steroids in paediatric heart surgery: eminence or evidence-based practice?Indian journal of thoracic and cardiovascular surgery · 2018
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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 8 institutions in 1 country.

Sara K PasqualiDepartment of Pediatrics, Duke University Medical Center, Duke Clinical Research Institute, Durham, NC, USA. sara.pasquali@duke.edu
Jennifer S Li
Xia He
Marshall L Jacobs
Sean M O'Brien
Matthew Hall
Robert D B Jaquiss
Karl F Welke
Eric D Peterson
Samir S Shah
J William Gaynor
Jeffrey P Jacobs
Clinical Research Institute · USDuke University · USChild Health Corporation of America · USCincinnati Children's Hospital Medical Center · USCleveland Clinic · USSeattle Children's Hospital · USUniversity of Pennsylvania · USUniversity of South Florida · US

Funding

Comparative Effectiveness of Medications Used in Congenital Heart SurgeryRC1HL099941 · NHLBI · DUKE UNIVERSITY · PI JACOBS, JEFFREY PHILLIP, LI, JENNIFER S · 2009 to 2010
$847k
Predicting adverse outcomes in children with community-acquired pneumoniaK01AI073729 · NIAID · CINCINNATI CHILDRENS HOSP MED CTR · PI SHAH, SAMIR SURESH · 2008 to 2012
$674k
Career Development in Outcomes Assessment in Congenital Heart SurgeryK08HL103631 · NHLBI · UNIVERSITY OF MICHIGAN AT ANN ARBOR · PI PASQUALI, SARA · 2010 to 2014
$502k
NHLBI NIH HHS 1K08HL103631-01NHLBI NIH HHS 1RC1HL099941-01NHLBI NIH HHS K08 HL103631NHLBI NIH HHS RC1 HL099941NIAID NIH HHS K01 AI073729NIAID NIH HHS K01 AI73729
6 · The paper itself

Abstract

backgroundRecent studies have called into question the benefit of perioperative corticosteroids in children undergoing heart surgery, but have been limited by the lack of placebo control, limited power, and grouping of various steroid regimens together in analysis. We evaluated outcomes across methylprednisolone regimens versus no steroids in a large cohort of neonates.

methodsClinical data from the Society of Thoracic Surgeons Database were linked to medication data from the Pediatric Health Information Systems Database for neonates (≤30 days) undergoing heart surgery (2004-2008) at 25 participating centers. Multivariable analysis adjusting for patient and center characteristics, surgical risk category, and within-center clustering was used to evaluate the association of methylprednisolone regimen with outcome.

resultsA total of 3180 neonates were included: 22% received methylprednisolone on both the day before and day of surgery, 12% on the day before surgery only, and 28% on the day of surgery only; 38% did not receive any perioperative steroids. In multivariable analysis, there was no significant mortality or length-of-stay benefit associated with any methylprednisolone regimen versus no steroids, and no difference in postoperative infection. In subgroup analysis by surgical-risk group, there was a significant association of methylprednisolone with infection consistent across all regimens (overall odds ratio 2.6, 95% confidence interval 1.3-5.2) in the lower-surgical-risk group.

conclusionsThis multicenter observational analysis did not find any benefit associated with methylprednisolone in neonates undergoing heart surgery and suggested increased infection in certain subgroups. These data reinforce the need for a large randomized trial in this population.

Indexed as

Perioperative PeriodAnti-Inflammatory AgentsCause of DeathCohort StudiesCombined Modality TherapyCross InfectionDrug Administration ScheduleFemaleHeart Defects, CongenitalHospital Information SystemsHospital MortalityHumansInfant, NewbornInfant, Premature, DiseasesLength of StayMaleAnti-Inflammatory AgentsMethylprednisolone

Identifiers

PMID22271697
PMCPMC3269116
OpenAlexW1983594459

What OpenQuestion holds

Textmetadata
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.