Evidence map›Paper›PMID 26376074›Full record

Trial reportPloS one2015

Neurodevelopmental Outcomes of Extremely Preterm Infants Randomized to Stress Dose Hydrocortisone.

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

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

Trial report in PloS one, 2015. 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 16 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
16citing papers in PubMed, 6 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

16 citing papers in PubMed, 6 syntheses or guidelines pooled it, 29 citations in OpenAlex.

  1. Pooled it
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  3. Pooled it
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  7. Neurodevelopmental Outcome at 20 Months Corrected Age in Extremely Preterm Infants After Exposure to Dexamethasone and Hydrocortisone in the NICU.The journal of pediatric pharmacology and therapeutics : JPPT : the official journal of PPAG · 2025
    Article
  8. Review
  9. Article
  10. [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
    Article
  11. Article
  12. Article
  13. Hydrocortisone and bronchopulmonary dysplasia: variables associated with response in premature infants.Journal of perinatology : official journal of the California Perinatal Association · 2020
    Article
  14. Article
  15. An evaluation of hydrocortisone dosing for neonatal refractory hypotension.Journal of perinatology : official journal of the California Perinatal Association · 2017
    Article
  16. 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

4 authors at 2 institutions in 1 country.

Nehal A ParikhDepartment of Pediatrics, University of Texas Medical School at Houston, Houston, TX, United States of America; Center for Perinatal Research, The Research Institute at Nationwide Children's Hospital, Columbus, OH, United States of America; Department of Pediatrics, The Ohio State University College of Medicine, Columbus, OH, United States of America; Division of Neonatology, Nationwide Children's Hospital, Columbus, OH, United States of America.
Kathleen A KennedyCenter for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
Robert E LaskyCenter for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
Jon E TysonCenter for Clinical Research and Evidence-Based Medicine, University of Texas Medical School at Houston, Houston, TX, United States of America.
Center for Clinical Research (United States) · USNationwide Children's Hospital · US

Funding

Nurological Diseases Research in High Risk NewbornsK23NS048152 · NINDS · UNIVERSITY OF TEXAS HLTH SCI CTR HOUSTON · PI PARIKH, NEHAL A. · 2005 to 2009
$817k
NINDS NIH HHS K23 NS048152NINDS NIH HHS K23-NS048152
6 · The paper itself

Abstract

objectiveTo compare the effects of stress dose hydrocortisone therapy with placebo on survival without neurodevelopmental impairments in high-risk preterm infants. STUDY

designWe recruited 64 extremely low birth weight (birth weight ≤1000 g) infants between the ages of 10 and 21 postnatal days who were ventilator-dependent and at high-risk for bronchopulmonary dysplasia. Infants were randomized to a tapering 7-day course of stress dose hydrocortisone or saline placebo. The primary outcome at follow-up was a composite of death, cognitive or language delay, cerebral palsy, severe hearing loss, or bilateral blindness at a corrected age of 18-22 months. Secondary outcomes included continued use of respiratory therapies and somatic growth.

resultsFifty-seven infants had adequate data for the primary outcome. Of the 28 infants randomized to hydrocortisone, 19 (68%) died or survived with impairment compared with 22 of the 29 infants (76%) assigned to placebo (relative risk: 0.83; 95% CI, 0.61 to 1.14). The rates of death for those in the hydrocortisone and placebo groups were 31% and 41%, respectively (P = 0.42). Randomization to hydrocortisone also did not significantly affect the frequency of supplemental oxygen use, positive airway pressure support, or need for respiratory medications.

conclusionsIn high-risk extremely low birth weight infants, stress dose hydrocortisone therapy after 10 days of age had no statistically significant effect on the incidence of death or neurodevelopmental impairment at 18-22 months. These results may inform the design and conduct of future clinical trials.

trial registrationClinicalTrials.gov NCT00167544.

Indexed as

Dose-Response Relationship, DrugFemaleHumansHydrocortisoneInfantInfant, Extremely PrematureInfant, NewbornMaleNervous SystemPregnancySafetyStress, PhysiologicalSurvival AnalysisHydrocortisone

Identifiers

PMID26376074
PMCPMC4573756
OpenAlexW2175626122

What OpenQuestion holds

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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.