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

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?

Study Overview

• Status: Enrolling by invitation
• Conditions: Bronchopulmonary Dysplasia
• Intervention / Treatment: Diagnostic test: Lung Ultrasound

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.

• Study Type: Observational
• Enrollment (Estimated): 150

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All infants who are born less than 32 weeks gestation will be enrolled in the study after obtaining parent's consent.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
RDS; Infant born less than 32 weeks gestation with diagnosis of respiratory distress syndrome. Lung ultrasounds will be performed on day of life 7, 14, 21, 28 and at corrected gestational age of 36 weeks.	Diagnostic test: Lung Ultrasound; Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.
PDA; In addition to being less than 32 weeks gestation, subject can qualify for study and receive a lung ultrasound scan at time of echo diagnosis of patent ductus arteriosus (PDA).	Diagnostic test: Lung Ultrasound; Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.
Steroid; Aims are : A: To evaluate changes in LUS scores pre and post treatment with systemic steroid course. B: To evaluate the predictive ability of LUS for successful extubation following course of systemic steroids. Lung ultrasound scans will be done prior to initiation of post-natal steroid, day 1, day 3, day 7, day 10 of treatment and 1 week after steroid is discontinued.	Diagnostic test: Lung Ultrasound; Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.
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.

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): April 1, 2025
• Study Completion (Estimated): April 1, 2025

Study Registration Dates

• First Submitted: June 21, 2023
• First Submitted That Met QC Criteria: June 21, 2023
• First Posted (Actual): June 29, 2023

Study Record Updates

• Last Update Posted (Estimated): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 6, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: lung ultrasound; bronchopulmonary dysplasia; BPD
• 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: 22-176

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