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

NCT ID: NCT06443528

Last Updated: 2024-06-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 1620 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2029-09-30

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.

Conditions

Lung Ultrasound; Bronchopulmonary Dysplasia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Preterm infants with GA <32 weeks

lung ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 0 Weeks
• Maximum Eligible Age: 32 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Hospital of Jilin University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

jddyyy

Identifier Type: -

Identifier Source: org_study_id