NCT03850457

Brief Summary

This study will establish a nationwide cohort of very preterm infants in China, to investigate the epidemiological characteristics and short-term outcomes of BPD in different NICUs around the country.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 28, 2019

Completed
24 days until next milestone

First Posted

Study publicly available on registry

February 21, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2024

Completed
Last Updated

February 25, 2025

Status Verified

February 1, 2025

Enrollment Period

3.9 years

First QC Date

January 28, 2019

Last Update Submit

February 24, 2025

Conditions

Bronchopulmonary Dysplasia

Keywords

bronchopulmonary dysplasiapreterm infantsepidemiologic characteristicsrisk factorsmortality

Outcome Measures

Primary Outcomes (2)

  • Bronchopulmonary dysplasia

    Diagnosis by the standard criteria developed by NICHD in 2016 and 2000.

    36 weeks of postmenstrual age

  • Mortality in NICU

    The preterm infants who dies owing to persistent parenchymal lung disease or other diseases in NICUs.

    through study completion, an average of 3 months

Secondary Outcomes (3)

  • NICU length of stay (LOS)

    through study completion, an average of 3 months

  • Hospital costs

    through study completion, an average of 3 months

  • Other complications

    through study completion, an average of 1 year

Interventions

No interventionOTHER

The treatments will be determined by their neonatologists and no additional investigational drugs will be applied to the infants included in this study.

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

All neonates of gestational age less than 32 weeks

You may qualify if:

  • Infants with GA less than 32 weeks;
  • Admitted to member neonatology centers during the period of recruitment;
  • Age at admission less than 28 days.

You may not qualify if:

  • Infants with major congenital anomalies, which include but not limited to serious congenital heart defects, chromosomal abnormalities, gastrointestinal atresias, brain malformations, congenital diaphragmatic hernia, renal agenesis or dysplastic kidneys;
  • Infants with inborn errors of metabolism;
  • Infants with severe heritable disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, 201102, China

Location

Related Publications (5)

  • Ehrenkranz RA, Walsh MC, Vohr BR, Jobe AH, Wright LL, Fanaroff AA, Wrage LA, Poole K; National Institutes of Child Health and Human Development Neonatal Research Network. Validation of the National Institutes of Health consensus definition of bronchopulmonary dysplasia. Pediatrics. 2005 Dec;116(6):1353-60. doi: 10.1542/peds.2005-0249.

    PMID: 16322158BACKGROUND

  • Jobe AH, Bancalari E. Bronchopulmonary dysplasia. Am J Respir Crit Care Med. 2001 Jun;163(7):1723-9. doi: 10.1164/ajrccm.163.7.2011060. No abstract available.

    PMID: 11401896BACKGROUND

  • Higgins RD, Jobe AH, Koso-Thomas M, Bancalari E, Viscardi RM, Hartert TV, Ryan RM, Kallapur SG, Steinhorn RH, Konduri GG, Davis SD, Thebaud B, Clyman RI, Collaco JM, Martin CR, Woods JC, Finer NN, Raju TNK. Bronchopulmonary Dysplasia: Executive Summary of a Workshop. J Pediatr. 2018 Jun;197:300-308. doi: 10.1016/j.jpeds.2018.01.043. Epub 2018 Mar 16. No abstract available.

    PMID: 29551318BACKGROUND

  • Krishnan U, Feinstein JA, Adatia I, Austin ED, Mullen MP, Hopper RK, Hanna B, Romer L, Keller RL, Fineman J, Steinhorn R, Kinsella JP, Ivy DD, Rosenzweig EB, Raj U, Humpl T, Abman SH; Pediatric Pulmonary Hypertension Network (PPHNet). Evaluation and Management of Pulmonary Hypertension in Children with Bronchopulmonary Dysplasia. J Pediatr. 2017 Sep;188:24-34.e1. doi: 10.1016/j.jpeds.2017.05.029. Epub 2017 Jun 20. No abstract available.

    PMID: 28645441BACKGROUND

  • Dai Y, Sheng K, Hu L. Diagnostic efficacy of targeted high-throughput sequencing for lower respiratory infection in preterm infants. Am J Transl Res. 2022 Nov 15;14(11):8204-8214. eCollection 2022.

    PMID: 36505277DERIVED

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Chao Chen, MD,PhD

    Children's Hospital of Fudan University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2019

First Posted

February 21, 2019

Study Start

January 1, 2020

Primary Completion

November 30, 2023

Study Completion

March 31, 2024

Last Updated

February 25, 2025

Record last verified: 2025-02

Locations

CN(1)