Body Weight Growth After Birth and Bronchopulmonary Dysplasia

April 28, 2023 updated by: Chen Long,MD, Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Association of Body Weight Growth After Birth and Bronchopulmonary Dysplasia(BPD)

Bronchopulmonary dysplasia (BPD) is one of the most common, complex, and severe diseases in preterm infants. BPD was first described as chronic pulmonary disease in survivors of severe respiratory distress syndrome (RDS) in 1967, which was also called as the "old" BPD. In recent years, the definition for BPD has developed a lot. The National Institute of Child Health and Human Development (NICHD) workshop in 2018 assessed BPD at 36 post-menstrual age (PMA) along with radiographic confirmation and used a severity grading of I-III. Although with effective surfactant supplement and oxygen support, BPD brings a great challenge to neonatologists.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Besides persistent inflammation, prolonged invasive ventilation and oxidative damage. body weight is the one of the most important factors to induce BPD. Poor extrauterine growth is commonly described in extremely preterm infants. But, the relationship of postnatal growth with BPD and respiratory morbidity is not entirely understood.

The aim of the present study is to assess whether body weight growth after birth is the risk factor for BPD.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400042
        • Children's Hospital of Chongqing Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 minute to 1 day (Child)

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

the preterm infants' gestational age is equal to or less than 32 weeks will be included in the study

Description

Inclusion Criteria:

  • equal to or less than 32 weeks' gestational age

Exclusion Criteria:

  • main congenital malformation
  • parents' refusal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
good body weight growth
body weight growth after birth is consistent with the growth curve
Other: good body weight growth
body weight growth after birth is consistent with the growth curve
poor body weight growth
body weight growth after birth is inconsistent with the growth curve
Other: poor body weight growth
body weight growth after birth is inconsistent with the growth curve

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the incidence of BPD
Time Frame: up to 36 weeks' gestational age
the infant was diagnosed with BPD
up to 36 weeks' gestational age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
body weight growth after birth
Time Frame: up to 36 weeks' gestational age
to assess whether body weight growth after birth is consistent with the growth curve
up to 36 weeks' gestational age

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daping Hospital and the Research Institute of Surgery of the Third Military Medical University

Collaborators

Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2021

Primary Completion (Anticipated)

December 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

September 12, 2021

First Submitted That Met QC Criteria

September 15, 2021

First Posted (Actual)

September 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 1, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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