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

NCT07216053 | Recruiting

• 1 other identifier: Pro2025-0102
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.

  The binary outcome of escalation vs non-escalation of respiratory support will be used to predict the accuracy of the three established POC LUS scoring systems (Three type-of-lung, Full LUS, high-risk pattern assessment) for identifying late preterm infants who experience respiratory decompensation. Respiration decompensation is defined by need for respiratory support in the form of HFNC (high flow nasal cannula), CPAP (continuous positive airway pressure), NIMV (non-invasive mechanical ventilation), mechanical ventilation or surfactant administration in infants initially in room air (RA) or nasal cannula (NC). Sensitivity, specificity, and area under ROC curve can be used to calculate the predictive accuracy. Escalation of respiratory support determined in the first 48 hours of life.

  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

  Comparison of the three POC LUS scoring systems performed in the first 4 hours of life to determine accuracy in predicting respiratory decompensation in the first 48 hours of life in late preterm infants. All three scores will be compared to the ultrasound results.

  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.

Secondary Outcomes (3)

• Correlation between POC LUS and the timing of signs of respiratory distress

  Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.

• Correlation between POC LUS and the severity of respiratory distress as determined by the length of support needed.

  Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.

• Correlation between POC LUS and the severity of respiratory distress as determined by the need for invasive respiratory support.

  Initial POCl LUS will be performed within the first 4 hours of life. Respiratory decompensation will be determined in the first 48 hours of life.

Study Arms (1)

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.

Diagnostic Test: Point of care lung ultrasound

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

Point of care lung ultrasound

Eligibility Criteria

• Age: 34 Weeks - 36 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Inborn infants born between 34w0d and 36w6d gestational age are admitted to the NICU or Well Baby Nursery.

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Hackensack Meridian Health: lead

Study Sites (1)

Hackensack Univeristy Medical Center

Hackensack, New Jersey, 07601, United States

RECRUITING

Related Publications (5)

• Raimondi F, Migliaro F, Sodano A, Ferrara T, Lama S, Vallone G, Capasso L. Use of neonatal chest ultrasound to predict noninvasive ventilation failure. Pediatrics. 2014 Oct;134(4):e1089-94. doi: 10.1542/peds.2013-3924. Epub 2014 Sep 1.

  PMID: 25180278 BACKGROUND

• Poerio A, Galletti S, Baldazzi M, Martini S, Rollo A, Spinedi S, Raimondi F, Zompatori M, Corvaglia L, Aceti A. Lung ultrasound features predict admission to the neonatal intensive care unit in infants with transient neonatal tachypnoea or respiratory distress syndrome born by caesarean section. Eur J Pediatr. 2021 Mar;180(3):869-876. doi: 10.1007/s00431-020-03789-z. Epub 2020 Sep 19.

  PMID: 32949291 BACKGROUND

• Xi G, Dai J, Wang X, Luo F, Lu C, Yang Y, Wang J. Ultrasound performed shortly after birth can predict the respiratory support needs of late preterm and term infants: A diagnostic accuracy study. Pediatr Pulmonol. 2021 Jul;56(7):2155-2163. doi: 10.1002/ppul.25389. Epub 2021 Apr 12.

  PMID: 33768734 BACKGROUND

• Brat R, Yousef N, Klifa R, Reynaud S, Shankar Aguilera S, De Luca D. Lung Ultrasonography Score to Evaluate Oxygenation and Surfactant Need in Neonates Treated With Continuous Positive Airway Pressure. JAMA Pediatr. 2015 Aug;169(8):e151797. doi: 10.1001/jamapediatrics.2015.1797. Epub 2015 Aug 3.

  PMID: 26237465 BACKGROUND

• Carnazzo SM, Nasikas S, Comisi FF. Lung Ultrasound in Neonates: A Narrative Review Along With Diagnostic Insights and Early Postnatal Applications. Cureus. 2024 Sep 30;16(9):e70487. doi: 10.7759/cureus.70487. eCollection 2024 Sep.

  PMID: 39479113 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Pulmonary Atelectasis; Dyspnea

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nicole Spillane

  Hackensack Meridian Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeanette Haugh

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2025
• First Posted: October 14, 2025
• Study Start: November 6, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: November 10, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)