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Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress

NCT ID: NCT05925075

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-17

Study Completion Date

2026-04-01

Brief Summary

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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

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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.

Conditions

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Bronchopulmonary Dysplasia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lung Ultrasound

Intervention Type DIAGNOSTIC_TEST

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).

Lung Ultrasound

Intervention Type DIAGNOSTIC_TEST

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.

Lung Ultrasound

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Lung Ultrasound

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

0 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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MedStar Georgetown University Hospital

OTHER

Sponsor Role collaborator

Baylor Scott and White Health

OTHER

Sponsor Role collaborator

Children's Hospital Los Angeles

OTHER

Sponsor Role collaborator

St. Joseph's Hospital and Medical Center, Phoenix

OTHER

Sponsor Role collaborator

LAC+USC Medical Center

OTHER

Sponsor Role collaborator

Phoenix Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hemananda Muniraman

Staff Physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Phoenix Children's

Phoenix, Arizona, United States

Site Status

Countries

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United States

Other Identifiers

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22-176

Identifier Type: -

Identifier Source: org_study_id