Bronchopulmonary DysplasiaNCT05925075
Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress
An observational study of Bronchopulmonary Dysplasia, run by Phoenix Children's Hospital at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 0 days and older
- Conditions the study is for
- Bronchopulmonary Dysplasia
- What is being tested?
- Lung Ultrasound
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Apr 2023to 24 Jun 2027
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All infants who are born less than 32 weeks gestation will be enrolled in the study after obtaining parent's consent.
Who may be able to join
- 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
Who cannot join
- Infants with critical congenital heart and lung conditions and those with genetic anomalies.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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?
Read the 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:
- 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.
- Conditions
- Bronchopulmonary Dysplasia
- Being tested
- Lung Ultrasound
- Keywords
- lung ultrasound, BPD, bronchopulmonary dysplasia
- Medical subject headings
- Bronchopulmonary Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lung UltrasoundDiagnostic test
Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Lung Ultrasound | |
| 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). Receives: Diagnostic Test: Lung Ultrasound | |
| 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. Receives: Diagnostic Test: Lung Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start17 Apr 2023
- Primary completion24 Jun 2027 (estimated)
- Study completion24 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchopulmonary DysplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Phoenix Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- MedStar Georgetown University Hospital, Baylor Scott and White Health, Children's Hospital Los Angeles, St. Joseph's Hospital and Medical Center, Phoenix, LAC+USC Medical Center
- Responsible party
- Principal investigator, Hemananda Muniraman, Phoenix Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05925075
- Sponsor's protocol ID
- 22-176
- Status last verified
- May 2026
- First submitted
- 21 Jun 2023
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No