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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress: A Multicenter Prospective Study
- ClinicalTrials.gov ID
- NCT05925075
- Acronym / sponsor ID
- 22-176
- Conditions
- Bronchopulmonary Dysplasia
- Keywords
- lung ultrasound, BPD, bronchopulmonary dysplasia
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Phoenix Children's HospitalUniversity, 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
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 24 Jun 2027 (estimated)
- Study completion
- 24 Jun 2027 (estimated)
- First posted
- 29 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RDS | – | Diagnostic Test: Lung UltrasoundInfant 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. |
| PDA | – | Diagnostic Test: Lung UltrasoundIn 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). |
| Steroid | – | Diagnostic Test: Lung UltrasoundAims 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. |
Who may qualify
- Ages
- 0 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Infants with critical congenital heart and lung conditions and those with genetic anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lung UltrasoundLung ultrasound to be performed at scheduled intervals as described in individual cohorts. | Diagnostic test | PDA, RDS, Steroid |
Primary outcome
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.
2 secondary outcomes
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchopulmonary Dysplasia, run by Phoenix Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.