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

Not yet recruiting

• Conditions: Bronchopulmonary Dysplasia; Lung Ultrasound
• Interventions: Diagnostic Test: lung ultrasound

• Registration Number: NCT06443528
• Lead Sponsor: The First Hospital of Jilin University

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-05-30
• Study First Submitted QC: 2024-05-30
• Study First Posted: 2024-06-05
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27
• Study Start: 2024-09-01
• Primary Completion: 2027-09-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 1620

Inclusion Criteria

1. Preterm infants with GA <32 weeks.
2. Infants with enrollment within 24 hours from birth
3. Parental written consent is obtained.

Exclusion Criteria

1. Complex congenital malformations or chromosomal abnormalities
2. Congenital lung diseases or congenital heart defects
3. Infants with enrollment after 24 hours from birth

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Preterm infants with GA <32 weeks	lung ultrasound	-

Primary Outcome Measures

Name	Time	Method
bronchopulmonary dysplasia	2024.06.01-2027.06.30	The outcome was bronchopulmonary dysplasia, as defined by the NIH in 2001 and Jensen in 2019：（1）no BPD as not receiving supplemental oxygen (O2) for 28 days or at 36 weeks;mild BPD as receiving O2 for greater than or equal to 28 days but not at 36 weeks; moderate BPD as receiving O2 for greater than or equal to28 days plus treatment with less than 30% O2 at 36 weeks; and severe BPD as receiving O2 for greater than or equal to 28 days plus greater than or equal to 30% O2 or positive pressure at 36 weeks；（2）No BPD was defined as breathing in room air at 36 weeks' PMA; grade 1 BPD as receipt of nasal cannula ≤2L/min (or hood O2); grade 2 BPD as nasal cannula \>2L/min, nasal continuous positive airway pressure (CPAP), or nasal intermittent positive pressure ventilation;and grade 3 BPD as invasive mechanical ventilation