Evidence map›Paper›PMID 39543521›Full record

ArticleBMC pediatrics2024

The HYdrocortisone for Bronchopulmonary Dysplasia Respiratory and Developmental (HYBRiD) outcomes study: protocol for a longitudinal cohort study.

Sara B DeMauro, Haresh Kirpalani, Kristina Ziolkowski, Susan Hintz, Kristi Watterberg, Jean Lowe, Seetha Shankaran, Sanjay Chawla, Betty Vohr, Michael Msall and 11 more

Registry-linked trialAbstract readClinical Trial Protocol
In one paragraph

Article in BMC pediatrics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01353313 (A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
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.

NCT01353313 phase3completednot on this map

A Randomized Controlled Trial of the Effect of Hydrocortisone on Survival Without Bronchopulmonary Dysplasia and on Neurodevelopmental Outcomes at 22 - 26 Months of Age in Intubated Infants < 30 Weeks Gestation Age

TypeinterventionalSponsorNICHD Neonatal Research NetworkRan2011 to 2024Enrolled800ConditionsInfant, Newborn, Infant, Small for Gestational Age, Infant, Very Low Birth Weight, Infant, PrematureArmsHydrocortisone, Placebo
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Article
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

21 authors.

Sara B DeMauroChildren's Hospital of Philadelphia, Philadelphia, USA. DeMauro@chop.edu.
Haresh KirpalaniChildren's Hospital of Philadelphia, Philadelphia, USA.
Kristina ZiolkowskiChildren's Hospital of Philadelphia, Philadelphia, USA.
Susan HintzSchool of Medicine, Stanford University, Stanford, USA.
Kristi WatterbergUniversity of New Mexico Health Sciences Center, Albuquerque, USA.
Jean LoweUniversity of New Mexico Health Sciences Center, Albuquerque, USA.
Seetha ShankaranUniversity of Texas at Austin, Austin, USA.
Sanjay ChawlaWayne State University, Detroit, USA.
Betty VohrWomen & Infants Hospital of Rhode Island and Warren Alpert Medical School of Brown University, Providence, USA.
Michael MsallComer Children's Hospital and Kennedy Research Center on Intellectual and Developmental Disabilities of the University of Chicago School of Medicine, Chicago, USA.
Carl D'AngioUniversity of Rochester School of Medicine and Dentistry, Rochester, USA.
Bradley A YoderUniversity of Utah School of Medicine, Salt Lake City, USA.
Khanh LaiUniversity of Utah School of Medicine, Salt Lake City, USA.
Sarah WinterUniversity of Utah School of Medicine, Salt Lake City, USA.
Tarah ColaizyUniversity of Iowa, Iowa City, USA.
Stephanie MerharCincinnati Children's Hospital Medical Center and University of Cincinnati College of Medicine, Cincinnati, USA.
Carla M BannAnalytics Division, RTI International, North Carolina, USA.
Marissa TrottaAnalytics Division, RTI International, North Carolina, USA.
Jamie NewmanAnalytics Division, RTI International, North Carolina, USA.
Aruna NatarajanNational Heart Lung and Blood Institute, Bethesda, USA.
Abhik DasNational Heart Lung and Blood Institute, Bethesda, USA.

Funding

Neonatal Research Network Data Coordinating Center (DCC)U10HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2008 to 2017
$62.3M
Data Ctr for the Cooperative Neonatal Research NetworkU01HD036790 · NICHD · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 1998 to 2007
$21.8M
NICHD Neonatal Research Network -- Cincinnati Clinical CenterUG1HD027853 · NICHD · CINCINNATI CHILDRENS HOSP MED CTR · PI STEPHANIE L MERHAR · 2016 to 2026
$3.7M
Clinical Center for NICHD/Neonatal Research NetworkUG1HD068244 · NICHD · UNIVERSITY OF PENNSYLVANIA · PI Sara Bonamo DeMauro, Eric C Eichenwald · 2016 to 2026
$3.6M
NICHD Cooperative Multicenter Neonatal Research Network - Utah CenterUG1HD087226 · NICHD · UTAH STATE HIGHER EDUCATION SYSTEM--UNIVERSITY OF UTAH · PI ROBIN K OHLS · 2016 to 2026
$3.3M
NICHD Neonatal Research Network - Stanford UniversityUG1HD027880 · NICHD · STANFORD UNIVERSITY · PI Valerie Chock · 2016 to 2026
$3.3M
NICHD Cooperative Multicenter Neonatal Research NetworkUG1HD053109 · NICHD · UNIVERSITY OF IOWA · PI Tarah Trinity Colaizy · 2016 to 2026
$3.2M
Eunice Kennedy Shriver NICHD Cooperative Multicenter Neonatal ResearchNetworkUG1HD053089 · NICHD · UNIVERSITY OF NEW MEXICO HEALTH SCIS CTR · PI Janell Fuller, Jessie R. Maxwell · 2016 to 2026
$3.2M
2/2 Hydrocortisone for BPD Respiratory and Developmental Outcomes Study (HYBRiD Outcomes Study): Data Coordinating CenterU24HL137729 · NHLBI · RESEARCH TRIANGLE INSTITUTE · PI DAS, ABHIK · 2017 to 2023
$2.7M
NICHD Neonatal Research NetworkUG1HD027904 · NICHD · WOMEN AND INFANTS HOSPITAL-RHODE ISLAND · PI MARON, JILL LAMANNA · 2016 to 2024
$2.1M
1/2 Hydrocortisone for BPD Respiratory and Developmental Outcomes Study (HYBRiD Outcomes Study): Clinical Coordinating CenterUH3HL137872 · NHLBI · CHILDREN'S HOSP OF PHILADELPHIA · PI DEMAURO, SARA BONAMO, HINTZ, SUSAN · 2018 to 2023
$1.9M
Rochester-Buffalo Neonatal Research GroupUG1HD068263 · NICHD · UNIVERSITY OF ROCHESTER · PI BLISS, JOSEPH MARK · 2016 to 2024
$1.6M
Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD21385Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD27853Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD27880Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD27904Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD36790Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD53089Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD53109Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD68244Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD68263Eunice Kennedy Shriver National Institute of Child Health and Human Development UG1HD87226NHLBI NIH HHS U24 HL137729NHLBI NIH HHS U24HL137729NHLBI NIH HHS UG3 HL137872NHLBI NIH HHS UH3 HL137872NHLBI NIH HHS UH3HL137872NICHD NIH HHS U01 HD036790NICHD NIH HHS U10 HD036790NICHD NIH HHS UG1 HD021385NICHD NIH HHS UG1 HD027853NICHD NIH HHS UG1 HD027880NICHD NIH HHS UG1 HD027904NICHD NIH HHS UG1 HD053089NICHD NIH HHS UG1 HD053109NICHD NIH HHS UG1 HD068244NICHD NIH HHS UG1 HD068263NICHD NIH HHS UG1 HD087226
6 · The paper itself

Abstract

backgroundBronchopulmonary dysplasia (BPD) affects up to half of extremely preterm infants, and is associated with adverse long-term respiratory, neurodevelopmental, and educational sequelae and costly health service and family economic outcomes. The NICHD Neonatal Research Network Hydrocortisone for Bronchopulmonary Dysplasia (BPD) Trial evaluated the efficacy and safety of hydrocortisone treatment to prevent BPD in high-risk infants. The trial enrolled 800 very preterm infants with respiratory failure and followed the participants until 2 years corrected age to assess safety of the trial intervention. Longer-term impacts of hydrocortisone exposure and severity of BPD on functional outcomes of high-risk infants remain unknown. The HYdrocortisone for BPD Respiratory and Developmental (HYBRiD) Outcomes Study extends follow-up of all surviving children enrolled in the Hydrocortisone for BPD Trial until early school age. It aims to characterize the childhood functional motor, cognitive, academic, and pulmonary outcomes of this large, well-phenotyped trial cohort.

methodsParents of surviving trial participants complete telephone questionnaires when their children are 3 and 4 years corrected age. A single in-person study visit takes place at early school age (5 years, 0 months to 7 years, 11 months corrected age). Children undergo a multidimensional assessment of functional outcomes and parents complete a battery of questionnaires. In 5 of 19 participating centers, respiratory mechanics are evaluated with impulse oscillometry. DISCUSSION: The HYBRiD Outcomes Study will be the largest and most comprehensive evaluation to date of the functional early school age outcomes of children with a history of severe neonatal lung disease and of children exposed to HC during infancy. This will substantially improve understanding of the longer-term implications of severe neonatal lung disease; provide data to facilitate the development of future randomized intervention trials in this population; and inform public policy by enhancing knowledge about school age resource requirements in children with a history of prematurity and lung disease.

trial registrationclinicaltrials.gov ID NCT01353313. Primary trial registration 5/11/11 modified to include followup through school age 12/13/17. This manuscript reflects version 3 of the trial manuscript, dated 10/12/2020.

Indexed as

Bronchopulmonary DysplasiaHydrocortisoneChildChild DevelopmentChild, PreschoolClinical Trials, Phase III as TopicFemaleFollow-Up StudiesHumansInfantInfant, Extremely PrematureInfant, NewbornLongitudinal StudiesMaleRandomized Controlled Trials as TopicHydrocortisoneBronchopulmonary dysplasiaChild behaviorChild developmentHydrocortisoneNeurodevelopmentOscillometryOutcomesPrematurity

Identifiers

PMID39543521
PMCPMC11562334

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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.