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NCT06443528

Comparison of Lung Ultrasound Scores With Clinical Models for Predicting Bronchopulmonary Dysplasia:A Multi-center Prospective Cohort Study

Sponsor: The First Hospital of Jilin University

View on ClinicalTrials.gov

Summary

This study aimed to fill this knowledge gap and designed a multicentre cohort study to verify the hypothesis that LUS has good reliability to predict BPD in China and to compare the predictive value of LUS and clinical models for the development of BPD at different time points in infants born before and after 28 weeks.

Key Details

Gender

All

Age Range

0 Weeks - 32 Weeks

Study Type

OBSERVATIONAL

Enrollment

1620

Start Date

2024-09-01

Completion Date

2029-09-30

Last Updated

2024-06-27

Healthy Volunteers

Not specified

Interventions

DIAGNOSTIC_TEST

lung ultrasound

All enrolled infants underwent LUS examination performed by two ultrasound physicians. Monitoring included a complete lung scan in the first 24 hours of life (T0) and at day 3 (T1). All neonates underwent weekly ultrasound examinations until 36 weeks postmenstrual age (T2, T3…), so that the T2 scan was carried out at the end of the first week of life. LUS was performed according to a standardized protocol \[13\] when the neonate was in a quiet state, during routine clinical care to minimise discomfort. All ultrasound images and videos were digitally recorded, anonymised, and reviewed by a senior independent ultrasonographer blinded to patients' clinical information. Each lung was divided into three regions according to the anterior and posterior axillary lines and the mammary line. The regions were the upper-anterior, lower-anterior, and latera regions.