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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Bronchopulmonary Dysplasia; Lung Ultrasound
• Intervention / Treatment: Diagnostic test: lung ultrasound

• Study Type: Observational
• Enrollment (Estimated): 1620

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Preterm infants with GA <32 weeks

Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: The First Hospital of Jilin University

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: May 30, 2024
• First Submitted That Met QC Criteria: May 30, 2024
• First Posted (Actual): June 5, 2024

Study Record Updates

• Last Update Posted (Actual): June 27, 2024
• Last Update Submitted That Met QC Criteria: June 26, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; Ventilator-Induced Lung Injury; Bronchopulmonary Dysplasia
• Other Study ID Numbers: jddyyy

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No