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

NCT06443528 | Not Yet Recruiting

• 1 other identifier: jddyyy
• Study Type: observational
• Target: 1,620
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• bronchopulmonary dysplasia

  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

  2024.06.01-2027.06.30

Study Arms (1)

Preterm infants with GA <32 weeks

Diagnostic Test: lung ultrasound

Interventions

lung ultrasound 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.

Preterm infants with GA <32 weeks

Eligibility Criteria

• Age: 0 Weeks - 32 Weeks
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Infants who meet all of the inclusion and exclusion criteria will be included

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The First Hospital of Jilin University: lead

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029
• Last Updated: June 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share