GER Poses a Potential Risk for Late Complications of BPD

Completed

• Conditions: Gastroesophageal Reflux; Bronchopulmonary Dysplasia

• Registration Number: NCT03014453
• Lead Sponsor: Shengjing Hospital

Brief Summary

Bronchopulmonary dysplasia (BPD) is a common condition in the low birth weight infants. Although most of the BPD symptoms improved after a regular treatment in infancy, there are still a few late complications left such as the frequent respiratory symptoms, a slower weight gain and even sudden death. These late complications have made so much trouble to the healthcare of BPD infants. How to find the risk factors and to reduce the prevalence of these late symptoms becomes necessary. In this study, a cohort of BPD infants was observed with the late complications obtained by a monthly followed up for 18 months after discharge, the prevalence and risk factors of the late complications of BPD were analyzed by logistic regression. As one of the risk factors, GER was verified whether to play a critical role in these late complications.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-05
• Study First Submitted QC: 2017-01-06
• Study Start: 2017-01-09
• Study First Posted: 2017-01-09
• Primary Completion: 2018-06-30
• Study Completion: 2018-07-22
• Results First Submitted: 2019-02-24
• Status Verified: 2020-03
• Results First Submitted QC: 2020-03-25
• Last Update Submitted: 2020-03-25
• Results First Posted: 2020-03-26
• Last Update Posted: 2020-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

• the extremely premature infants with bronchopulmonary dysplasia

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Exclusion Criteria

• other congenital malformations such as gastrointestinal and or neurogenic disease

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the Late Complications of BPD Infants	18 months	In all patients, complications were evaluated via questionnaires at 3, 6, 9 and 12 months corrected for premature age, including respiratory symptoms (including home respiratory support, respiratory medication administration, cough without cold at least once per week, re-hospitalization due to respiratory diseases), vomiting when feeding, hypoxic ischemic injury, retinopathy of prematurity, rehospitalization and sudden death.

Trial Locations

Locations (1)

Shengjing Hospital; 🇨🇳 Shenyang, Liaoning, China