Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress

Phoenix Children's Hospital

Status: Invitation-only

Conditions: Bronchopulmonary Dysplasia

Treatments: Diagnostic Test: Lung Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT05925075

22-176

Details and patient eligibility

About

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?

Full 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.

Enrollment: 150 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

RDS

Description:

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.

Treatment:

Diagnostic Test: Lung Ultrasound

PDA

Description:

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).

Treatment:

Diagnostic Test: Lung Ultrasound

Steroid

Description:

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.

Treatment:

Diagnostic Test: Lung Ultrasound