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Clinical trial Recruiting at 1 site Observational Ages 34 Weeks to 36 Weeks

Lung ultrasound to predict breathing problems in late‑preterm babies

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

Run by Hackensack Meridian Health · NCT07216053 · Data updated 2026-11-12

We will test whether early point‑of‑care lung ultrasound can predict which late‑preterm newborns will have breathing problems in the first 48 hours of life.

Quick facts

Study typeObservational
Ages34 Weeks to 36 Weeks
SexAll
Enrollment300 (estimated)
SponsorHackensack Meridian Health
Academic / other
Locations1 site (Hackensack, New Jersey)
StatusRecruiting
StartedNovember 6, 2025
Main results expectedNovember 2027
Study endsNovember 2027
Registry record updatedMay 22, 2026
Trial IDNCT07216053 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Inborn infants born between 34w0d and 36w6d who are in room air or on ≤1 L/min nasal cannula and are admitted to the well baby nursery or NICU without major anomalies are ideal candidates.

Probably not a fit

Infants born before 34 weeks or after 36w6d, or those with major genetic syndromes, structural cardiac or pulmonary defects, severe birth acidosis or very low Apgar scores, are excluded and would not receive benefit from this protocol.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study enrolls inborn late‑preterm infants (34w0d–36w6d) who are in room air or on low‑flow nasal cannula and admitted to the well baby nursery or NICU. Each infant will receive point‑of‑care lung ultrasound shortly after birth and investigators will apply three published lung ultrasound scoring systems (type‑of‑lung, high‑risk pattern, and total LUS) to the images. The primary outcome is respiratory decompensation within the first 48 hours, defined by need for escalation of respiratory support or NICU transfer. Results will compare the predictive performance of the three scoring approaches in this specific late‑preterm population while excluding infants with major anomalies, structural cardiac/pulmonary defects, severe birth acidosis, or suspected significant hemorrhage.

Why it matters

Potential benefit: If successful, earlier identification of babies at high risk for respiratory decline could prompt timely transfer or escalation of care and reduce unexpected decompensations.

How similar studies have gone: Previous studies in extremely or moderately preterm and term infants have shown lung ultrasound scoring can predict later need for respiratory support, but data specifically focused on late‑preterm infants are limited.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

  • Hackensack Univeristy Medical Center
    Hackensack, New Jersey, United States     Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.