NCT07216053 Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
| NCT ID | NCT07216053 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hackensack Meridian Health |
| Condition | Pre-Term |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-11-06 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-11-06 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Respiratory morbidity presents a significant clinical challenge in the neonatal period, and an individual patient's clinical course is often difficult to predict. This is especially true for late-preterm infants, who share some of the same risks of premature babies in terms or respiratory morbidity, but whose births may not always be attended by a neonatologist, or who may be born at hospitals with lower level Neonatal Intensive Care Units (NICUs) and require transfer if they decompensate. With this study, the aim is to 1) determine the efficacy of early point of care lung ultrasound (LUS) to predict respiratory decompensation in the first 48 hours of life in late preterm infants and 2) to compare the performance of three lung ultrasound scoring systems, 3 type-of-lung, high risk pattern and total LUS scoring systems.
Eligibility 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
Contact & Investigator
Nicole Spillane
PRINCIPAL INVESTIGATOR
Hackensack Meridian Health
Frequently Asked Questions
Who can join the NCT07216053 clinical trial?
This trial is open to participants of all sexes, aged 34 Weeks or older, up to 36 Weeks, studying Pre-Term. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07216053 currently recruiting?
Yes, NCT07216053 is actively recruiting participants. Contact the research team at Jeanette.Haugh@HMHN.org for enrollment information.
Where is the NCT07216053 trial being conducted?
This trial is being conducted at Hackensack, United States.
Who is sponsoring the NCT07216053 clinical trial?
NCT07216053 is sponsored by Hackensack Meridian Health. The principal investigator is Nicole Spillane at Hackensack Meridian Health. The trial plans to enroll 300 participants.