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Enrolling by Invitation

NCT Number: NCT05925075

Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress

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?

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Key information

Conditions

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 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Phoenix Children's

Phoenix, Arizona, 85016, United States

About this study

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:

  • LUS scores would have a predictive ability to identify extreme preterm infants at risk of BPD with AUC>0.8.
  • Higher LUS scores would correlate with higher severity of hemodynamically significant PDA.
  • 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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Lung Ultrasound

Diagnostic Test

Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.

Primary outcomes

  1. Assess predictive ability of lung ultrasound scores in infants at risk of developing bronchopulmonary dysplasia (BPD)

    Time frame: The lung ultrasounds will be performed on day of life 7, 14, 21 and 28 and diagnosis of BPD would be per standard criteria.

    The primary outcome is to assess accuracy measures including specificity, sensitivity and area under ROC of lung ultrasound cut offs for predicting BPD.

Secondary outcomes

  1. Association between lung ultrasound scores and severity of patent ductus arteriosus.

    Time frame: The lung ultrasound would be performed around the time of echocardiographic diagnosis of patent ductus arteriosus and severity determined by standard criteria.

    Secondary outcome is to assess correlation between lung ultrasound scores and severity of patent ductus arteriosus.

  2. Comparison of lung ultrasound scores pre and post systemic steroid course administration

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Collaborators

  • 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

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jun 29, 2023
Registry last updated
May 22, 2026

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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