Recruiting

Lung Ultrasound

Sponsor:

Hackensack Meridian Health

Code:

NCT07216053

Conditions

Pre-Term

Respiratory Distress of Newborn

Premature

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

Interventions

Point of care lung ultrasound

Study Details

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.

Conditions

Pre-Term

Respiratory Distress of Newborn

Premature

Study ID

NCT07216053

Start date

Nov 6, 2025

Status verified date

May, 2026

Completion date

Nov, 2027

Anticipated

Primary completion date

Nov, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Point of care lung ultrasound

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

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. ]
  • Compare the predictive accuracy of the three scoring systems [ 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 and Locations

Central contacts

Jeanette Haugh

551-996- 3457Jeanette.Haugh@HMHN.org

Locations

Hackensack Univeristy Medical Center

Recruiting

Hackensack, New Jersey, United States, 07601

More Information

Sponsor

Hackensack Meridian Health

Last update posted

May 22, 2026

Last verified

May, 2026

Keywords

  • Lung Ultrasound
  • Respiratory Decompensation
  • Late Preterm Neonates
  • respiratory distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Hackensack Meridian Health on 2026-05-22.