Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lung Ultrasound.
- Who it may be relevant to
- Registry conditions: Bronchopulmonary Dysplasia. Basic parameters: from 0 Days · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Point of Care Lung Ultrasound in Preterm Infants With Respiratory Distress: A Multicenter Prospective Study
Overview
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.
Interventions
- Diagnostic test Lung Ultrasound
Lung ultrasound to be performed at scheduled intervals as described in individual cohorts.
Primary outcome measures
- 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.]
Secondary outcome measures (2)
- 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.]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Phoenix Children's — Phoenix
Identifiers
NCT: NCT05925075 · 22-176