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Clinical Trials/NCT06443528
NCT06443528
Not yet recruiting
Not Applicable

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

The First Hospital of Jilin University0 sites1,620 target enrollmentSeptember 1, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lung Ultrasound
Sponsor
The First Hospital of Jilin University
Enrollment
1620
Primary Endpoint
bronchopulmonary dysplasia
Status
Not yet recruiting
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2024
End Date
September 30, 2029
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Complex congenital malformations or chromosomal abnormalities
  • Congenital lung diseases or congenital heart defects
  • Infants with enrollment after 24 hours from birth

Outcomes

Primary Outcomes

bronchopulmonary dysplasia

Time Frame: 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

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