Lung ultrasound to predict breathing problems in late‑preterm babies
Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
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 type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 34 Weeks to 36 Weeks |
| Sex | All |
| Sponsor | Hackensack Meridian Health Academic / other |
| Locations | 1 site (Hackensack, New Jersey) |
| Trial ID | NCT07216053 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hackensack, New Jersey
- Hackensack Univeristy Medical Center — Hackensack, New Jersey, United States (Recruiting)
Study contacts
- Principal investigator: Nicole Spillane — Hackensack Meridian Health
- Study coordinator: Jeanette Haugh
- Email: Jeanette.Haugh@HMHN.org
- Phone: 551-996- 3457
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.