Body Weight Growth After Birth and Bronchopulmonary Dysplasia

NCT05053269 | Withdrawn DMC

• 1 other identifier: 2020228
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Bronchopulmonary Dysplasia; Preterm

Outcome Measures

Primary Outcomes (1)

• the incidence of BPD

  the infant was diagnosed with BPD

  up to 36 weeks' gestational age

Secondary Outcomes (1)

• body weight growth after birth

  up to 36 weeks' gestational age

Study Arms (2)

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

good body weight growth OTHER

body weight growth after birth is consistent with the growth curve

good body weight growth

poor body weight growth OTHER

body weight growth after birth is inconsistent with the growth curve

poor body weight growth

Eligibility Criteria

• Age: 1 Minute - 1 Day
• Sex: all
• Age Groups: Child (0-17)
• 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

You may qualify if:

• equal to or less than 32 weeks' gestational age

You may not qualify if:

• main congenital malformation
• parents' refusal

Sponsors & Collaborators

• Daping Hospital and the Research Institute of Surgery of the Third Military Medical University: lead
• Children's Hospital of Chongqing Medical University: collaborator

Study Sites (1)

Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400042, China

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia; Premature Birth

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: director

Study Record Dates

• First Submitted: September 12, 2021
• First Posted: September 22, 2021
• Study Start: October 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2023

Record last verified: 2022-10

Locations

CN (1)