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

Part of paid clinical trials in Hackensack, New Jersey.

Sponsor
Hackensack Meridian Health
Study ID
NCT07216053
Status
Recruiting
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Conditions

  • Pre-Term
  • Premature
  • Respiratory Distress of Newborn

Eligibility Criteria

Sex
ALL
Age
34 Weeks - 36 Weeks
Healthy Volunteers
Not accepted

Interventions

  • Point of care lung ultrasound — DIAGNOSTIC_TEST
    Point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems

Study Details

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.

Key Dates

Start date
Nov 6, 2025
Status verified
May 2026
Primary completion
Nov 30, 2027
Completion
Nov 30, 2027

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: 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.

Primary Outcome Measure

Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants. [ Time Frame: 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. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Hackensack Univeristy Medical CenterHackensackNew Jersey07601-

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