Point of Care Lung Ultrasound in Preterm Infants with Respiratory Distress

NCT05925075 | Enrolling By Invitation

• 1 other identifier: 22-176
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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?

Conditions

Bronchopulmonary Dysplasia

Keywords

lung ultrasound; BPD; bronchopulmonary dysplasia

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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

  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.

Study Arms (3)

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.

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).

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.

Diagnostic Test: Lung Ultrasound

Interventions

Lung Ultrasound DIAGNOSTIC_TEST

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

PDA; RDS; Steroid

Eligibility Criteria

• Age: 0 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Infants with critical congenital heart and lung conditions and those with genetic anomalies.

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• MedStar Georgetown University Hospital: collaborator
• Baylor Scott and White Health: collaborator
• Children's Hospital Los Angeles: collaborator
• St. Joseph's Hospital and Medical Center, Phoenix: collaborator
• LAC+USC Medical Center: collaborator

Study Sites (1)

Phoenix Children's

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Bronchopulmonary Dysplasia

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung Injury; Lung Injury; Lung Diseases; Respiratory Tract Diseases; Infant, Premature, Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: June 29, 2023
• Study Start: April 17, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)