Body Weight Growth After Birth and Bronchopulmonary Dyspl... | NCT05053269

Studies
Body Weight Growth After Birth and Bronchopulmonary Dysplasia

NCT05053269

Sponsor

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

Status

Withdrawn

Last Update Posted

May 1, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Bronchopulmonary Dysplasia
Preterm

Interventions

good body weight growth
poor body weight growth

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2022

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

none was included

Expanded Access Info

Start Date

Oct 1, 2021Actual

Primary Completion Date

Dec 31, 2024Estimated

Completion Date

Dec 31, 2024Estimated

First Submitted Date

Sep 12, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 22, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 28, 2023

Last Update Posted Date

May 1, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Chen Long,MD, director, Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversityPrincipal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Children's Hospital of Chongqing Medical University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
good body weight growth		body weight growth after birth is consistent with the growth curve	Other: good body weight growth
poor body weight growth		body weight growth after birth is inconsistent with the growth curve	Other: poor body weight growth

Interventions

Name	Type	Description	Arm Group Labels	Other Names
good body weight growth	Other	body weight growth after birth is consistent with the growth curve	good body weight growth

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

equal to or less than 32 weeks' gestational age

Exclusion Criteria:

main congenital malformation
parents' refusal

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Minute

Maximum Age

1 Day

Standard Ages

Child

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Chongqing Medical University		Chongqing	Chongqing Municipality	400042	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D001997	Bronchopulmonary Dysplasia
D047928	Premature Birth

Ancestor Terms

ID	Term
D055397	Ventilator-Induced Lung Injury
D055370	Lung Injury
D008171	Lung Diseases
D012140	Respiratory Tract Diseases

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Browse Branches

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