Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress

Bronchopulmonary Dysplasia Clinical Trial

Official title:

Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress: A Multicenter Prospective Study

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05925075
• Other study ID #: 22-176
• Status: Enrolling by invitation
• Start date: April 17, 2023
• Est. completion date: April 1, 2025

Study information

• Verified date: November 2023
• Source: Phoenix Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 150
• Est. completion date: April 1, 2025
• Est. primary completion date: April 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Days and older

Eligibility

Inclusion Criteria:

Infants born less than 32 weeks gestation and meet one or more of the below criteria A) Diagnosis of Respiratory Distress Syndrome B) Diagnosis of PDA C) Post-natal steroid treatment for the purpose of weaning off ventilation support

Exclusion Criteria:

Infants with critical congenital heart and lung conditions and those with genetic anomalies.

Related Conditions & MeSH terms

• Bronchopulmonary Dysplasia

Intervention

Diagnostic Test:
• Lung Ultrasound
Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.

Locations

Country	Name	City	State
United States	Phoenix Children's	Phoenix	Arizona

Sponsors (6)

Lead Sponsor	Collaborator
Phoenix Children's Hospital	Baylor Scott and White Health, Children's Hospital Los Angeles, LAC+USC Medical Center, MedStar Georgetown University Hospital, St. Joseph's Hospital and Medical Center, Phoenix

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess predictive ability of lung ultrasound scores in infants at risk of developing bronchopulmonary dysplasia (BPD)	The primary outcome is to assess accuracy measures including specificity, sensitivity and area under ROC of lung ultrasound cut offs for predicting BPD.	The lung ultrasounds will be performed on day of life 7, 14, 21 and 28 and diagnosis of BPD would be per standard criteria.
Secondary	Association between lung ultrasound scores and severity of patent ductus arteriosus.	Secondary outcome is to assess correlation between lung ultrasound scores and severity of patent ductus arteriosus.	The lung ultrasound would be performed around the time of echocardiographic diagnosis of patent ductus arteriosus and severity determined by standard criteria.
Secondary	Comparison of lung ultrasound scores pre and post systemic steroid course administration	Comparison of lung ultrasound scores prior to and after course of systemic steroid administration would be analyzed using paired T-test or the signed Wilcoxon rank sum test.	The lung ultrasound would be performed prior to steroid administration, 24 hours, 72 hours, 7 days, 10 days and 17 days after the first dose of 10 day course of systemic steroid administration.