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Not Yet RecruitingNCT06443528

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

Status
Not Yet Recruiting
Phase
Study type
Observational
Enrollment
1,620 (estimated)
Sponsor
The First Hospital of Jilin University · Academic / Other
Sex
All
Age
0 Weeks – 32 Weeks
Healthy volunteers

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

Interventions

TypeNameDescription
DIAGNOSTIC_TESTlung ultrasoundAll 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.

Timeline

Start date
2024-09-01
Primary completion
2027-09-30
Completion
2029-09-30
First posted
2024-06-05
Last updated
2024-06-27

Source: ClinicalTrials.gov record NCT06443528. Inclusion in this directory is not an endorsement.