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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 7 months
Maximum Age: 8 months
Healthy Volunteers: f
View:

• 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)

Locations
United States
New Jersey
Hackensack Univeristy Medical Center
RECRUITING
Hackensack
Contact Information
Primary
Jeanette Haugh
Jeanette.Haugh@HMHN.org
551-996- 3457
Time Frame
Start Date: 2025-11-06
Estimated Completion Date: 2027-11
Participants
Target number of participants: 300
Treatments
Point of care lung ultrasound
Recruited babies will undergo point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems. Infants will be followed during initial hospitalization. Respiratory decompensation will be determined by 48 hours of life. If respiratory decompensation occurs, the onset of signs of respiratory distress (determined by initiation of respiratory support) and the severity of respiratory distress (determined by length of time on respiratory support) will be measured.
Related Therapeutic Areas
Sponsors
Leads: Hackensack Meridian Health

This content was sourced from clinicaltrials.gov