Clinical trial NCT05925075: Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress
Official title: Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress: a Multicenter Prospective Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Bronchopulmonary Dysplasia
Keywords: lung ultrasound
BPD
bronchopulmonary dysplasia
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
Collaborators: name: MedStar Georgetown University Hospital
name: Baylor Scott and White Health
name: Children's Hospital Los Angeles
name: St. Joseph's Hospital and Medical Center, Phoenix
name: LAC+USC Medical Center
First posted: 2023-06-29
Enrollment: 150
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All infants who are born less than 32 weeks gestation will be enrolled in the study after obtaining parent's consent.

Brief 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 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:

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Assess predictive ability of lung ultrasound scores in infants at risk of developing bronchopulmonary dysplasia (BPD)
timeFrame: 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:
measure: Association between lung ultrasound scores and severity of patent ductus arteriosus.
timeFrame: The lung ultrasound would be performed around the time of echocardiographic diagnosis of patent ductus arteriosus and severity determined by standard criteria.
measure: Comparison of lung ultrasound scores pre and post systemic steroid course administration
timeFrame: 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.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's
state: Arizona
Study officials:
References: