Evidence map›Paper›PMID 23140612›Full record

Trial reportThe Journal of pediatrics2013

Pilot randomized trial of hydrocortisone in ventilator-dependent extremely preterm infants: effects on regional brain volumes.

Nehal A Parikh, Kathleen A Kennedy, Robert E Lasky, Georgia E McDavid, Jon E Tyson

2 registry-linked trialsOpen access · greenAbstract readRandomized Controlled Trial
In one paragraph

Trial report in The Journal of pediatrics, 2013. 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 28 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 9 pooled it
2.2field-weighted citation impact, top 12% 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.

NCT00167544 phase2completednot on this map

A Randomized Trial of Hydrocortisone in Very Preterm Infants at High Risk for Neurologic and Pulmonary Impairments

TypeinterventionalSponsorNationwide Children's HospitalRan2005 to 2012Enrolled64ConditionsBronchopulmonary Dysplasia, Encephalomalacia, Premature BirthArmsHydrocortisone, Placebo
NCT04971694 completednot on this mapstarted 2021, after this paper: background citation

A Retrospective Chart Review Evaluating the Impact of Steroid, Diuretic, and Fluid Use Practice Trends in Extreme Premature Infants At Risk for Bronchopulmonary Dysplasia (BPD) At a Single Center Neonatal Intensive Care Unit

TypeobservationalSponsorPediatrixRan2021 to 2024Enrolled175ConditionsBPD - Bronchopulmonary DysplasiaArmsNo interventions or procedures
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 9 syntheses or guidelines pooled it, 58 citations in OpenAlex.

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  16. [Association between early parenteral nutrition and the development of bronchopulmonary dysplasia in preterm infants].Zhongguo dang dai er ke za zhi = Chinese journal of contemporary pediatrics · 2023
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  19. Optimizing respiratory management in preterm infants: a review of adjuvant pharmacotherapies.Journal of perinatology : official journal of the California Perinatal Association · 2021
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 4 institutions in 2 countries.

Nehal A ParikhDepartment of Pediatrics, Neonatal-Perinatal Medicine, University of Texas Medical School at Houston, Houston, TX, USA. Nehal.Parikh@NationwideChildrens.org
Kathleen A Kennedy
Robert E Lasky
Georgia E McDavid
Jon E Tyson
Memorial Hermann · USCenter for Clinical Research (United States) · USThe Ohio State University · USThe University of Texas Health Science Center at Houston · US

Funding

U OF TEXAS HLTH SCI CTR HOUSTON CENTER FOR CLINICAL AND TRANSLATIONAL SCIENCESUL1RR024148 · NCRR · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI MCPHERSON, DAVID D · 2006 to 2010
$27.9M
NICHD Cooperative Multicenter Neonatal Research NetworkU10HD021373 · NICHD · UNIVERSITY OF TEXAS SW MED CTR/DALLAS · PI KENNEDY, KATHLEEN A · 1991 to 2015
$6.1M
Nurological Diseases Research in High Risk NewbornsK23NS048152 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI PARIKH, NEHAL A. · 2005 to 2009
$817k
NCRR NIH HHS UL1 RR024148NCRR NIH HHS UL1RR024148NICHD NIH HHS U10 HD021373NINDS NIH HHS K23 NS048152NINDS NIH HHS K23-NS048152
6 · The paper itself

Abstract

objectiveTo test the hypothesis that high-risk ventilator-dependent extremely low birth weight (birth weight ≤1000 g) infants treated with 7 days of hydrocortisone will have larger total brain tissue volumes than placebo treated infants. STUDY

designA predetermined sample size of 64 extremely low birth weight infants, between 10-21 days old and ventilator-dependent with a respiratory index score ≥2, were randomized to systemic hydrocortisone (17 mg/kg cumulative dose) or saline placebo. Primary outcome was total brain tissue volume. Volumetric magnetic resonance imaging was performed at 38 weeks postmenstrual age; brain tissue regions were segmented and quantified automatically with a high degree of accuracy and 9 structures were segmented manually. All analyses of regional brain volumes were adjusted by postmenstrual age at magnetic resonance imaging scan.

resultsThe study groups were similar at baseline and 8 infants died in each arm. Unadjusted total brain tissue volume (mean ± SD) in the hydrocortisone (N = 23) and placebo treated infants (N = 21) was 272 ± 40.3 cm(3) and 277.8 ± 59.1 cm(3), respectively (adjusted mean difference: 6.35 cm(3) (95% CI: (-20.8, 32.5); P = .64). Three of the 31 hydrocortisone treated infants and 5 of the 33 placebo treated infants survived without severe bronchopulmonary dysplasia (relative risk 0.62, 95% CI: 0.13, 2.66; P = .49). No significant differences were noted in prespecified secondary outcomes of regional structural volumes or days on respiratory support. No adverse effects of hydrocortisone were observed.

conclusionsLow dose hydrocortisone in high-risk ventilator-dependent infants after a week of age had no discernible effect on regional brain volumes or pulmonary outcomes prior to neonatal intensive care unit discharge.

Indexed as

Infant, PrematureAnthropometryBrainBrain InjuriesBronchopulmonary DysplasiaFemaleHumansHydrocortisoneInfant, Extremely Low Birth WeightInfant, NewbornMagnetic Resonance ImagingMalePlacebosReproducibility of ResultsRespiration, ArtificialRiskHydrocortisonePlacebos

Identifiers

PMID23140612
PMCPMC3609889
OpenAlexW2004966322

What OpenQuestion holds

Textmetadata
LicenceTDM
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.