Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates

This study is looking at how well a diagnostic test called point-of-care lung ultrasound (POC LUS) can predict breathing problems in late preterm babies. These are babies born between 34 and 36 weeks of pregnancy. Researchers will use POC LUS within the first 4 hours of a baby's life and score the results using three different systems. The goal is to see how accurate these scoring systems are at predicting if a baby will need more breathing support within the first 48 hours. This study aims to help doctors better understand and prepare for potential respiratory issues in these vulnerable newborns.

Study design
This is an observational study planning to enroll 300 participants. It will compare the accuracy of three different lung ultrasound scoring systems.
What's involved
Your baby would have a point-of-care lung ultrasound (POC LUS) within the first 4 hours of life. Researchers will then monitor for escalation of respiratory support in the first 48 hours.
Compensation
Not stated in the trial record.
Follow-up
The primary outcomes are measured within the first 48 hours of life after the initial lung ultrasound.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07216053

Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates

Recruiting
Not specifiedAges 34–36Observational
Hackensack Meridian Health
~300 participants
Updated 2026-05-22 on ClinicalTrials.gov
What's tested:Point of care lung ultrasound

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.
Measured over Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.
+1 more outcome measured
Pre-Term
Respiratory Distress of Newborn
Premature
1 sites across 1 states
New Jersey1
  • Nicole Spillane · PRINCIPAL_INVESTIGATOR · Hackensack Meridian Health

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

Inborn infants born between 34w0d and 36w6d gestational age
In RA or 1 Litre per minute 1LPM NC (room air (RA) or nasal cannula (NC))
Admitted to NICU or Well Baby Nursery (WBN)

Exclusion

Patients born \<34 weeks or \>36w6d
Major genetic anomaly or syndromic condition
Cardiac or pulmonary structural defects
Cord pH \<7.0 or 5 minute APGAR 5 or less
Suspected fetal hemorrhage or other source of significant anemia at birth
  • Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.Initial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.

    The binary outcome of escalation vs non-escalation of respiratory support will be used to predict the accuracy of the three established POC LUS scoring systems (Three type-of-lung, Full LUS, high-risk pattern assessment) for identifying late preterm infants who experience respiratory decompensation. Respiration decompensation is defined by need for respiratory support in the form of HFNC (high flow nasal cannula), CPAP (continuous positive airway pressure), NIMV (non-invasive mechanical ventilation), mechanical ventilation or surfactant administration in infants initially in room air (RA) or nasal cannula (NC). Sensitivity, specificity, and area under ROC curve can be used to calculate the predictive accuracy. Escalation of respiratory support determined in the first 48 hours of life.

  • Compare the predictive accuracy of the three scoring systemsInitial POC LUS will be performed within the first 4 hours of life. Escalation of respiratory support determined in the first 48 hours of life.

    Comparison of the three POC LUS scoring systems performed in the first 4 hours of life to determine accuracy in predicting respiratory decompensation in the first 48 hours of life in late preterm infants. All three scores will be compared to the ultrasound results.