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.

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Key information

Conditions

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

Age range

0 week–32 week

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Important dates

Study start: 2024
Primary completion: 2027
Study completion: 2029
First posted: Jun 5, 2024
Registry last updated: Jun 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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