NCT05925075

Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress

Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress: a Multicenter Prospective Study

• Status: Enrolling By Invitation
• Phase: —
• Study type: Observational
• Enrollment: 150 (estimated)
• Sponsor: Phoenix Children's Hospital · Academic / Other
• Sex: All
• Age: 0 Days
• Healthy volunteers: Not accepted

Summary

The goal of this observational study is to learn about the role of bedside lung ultrasound in infants born prematurely with breathing problems. The main question this study aims to answer is: Can bedside lung ultrasound performed in the first month of life predict the development of chronic lung disease in premature infants?

Detailed description

This is a multicenter study including preterm infants born less than 32 weeks gestational age and with a diagnosis of respiratory distress syndrome (RDS). Our primary aim is to determine the ability of lung ultrasounds performed in the first month of life to predict the development of bronchopulmonary dysplasia (BPD) at 36 weeks postmenstrual age. Secondary aims will evaluate the association of lung ultrasound scores with the severity of hemodynamically significant patent ductus arteriosus (PDA) at time of diagnosis, as well as describe lung ultrasound changes pre and post-treatment with systemic steroid course. Hypothesis: 1. LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC\>0.8. 2. Higher LUS scores would correlate with higher severity of hemodynamically significant PDA. 3. LUS scores are expected to be lower after the course of systemic steroids and with lower scores are expected to predict successful extubation following the course of systemic steroids.

Conditions

• Bronchopulmonary Dysplasia

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Lung Ultrasound	Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.

Timeline

• Start date: 2023-04-17
• Primary completion: 2026-04-01
• Completion: 2026-04-01
• First posted: 2023-06-29
• Last updated: 2024-11-29

Locations

1 site across 1 country: United States