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Recruiting NCT07216053

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

— Observational Pre-Term Respiratory Distress of Newborn Premature

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An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Point of care lung ultrasound.
Who it may be relevant to
Registry conditions: Pre-Term, Respiratory Distress of Newborn, Premature. Basic parameters: 34 Weeks — 36 Weeks · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Detailed description

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.

Point of care (POC) lung ultrasound (LUS) is a relatively new and potentially underused method of assessing a neonate's respiratory status. The imaging modality has long been used to assess for common pulmonary pathologies such as pleural effusion and pneumothorax, but recent studies have begun to examine the utility of POC LUS for predicting a patient's clinical course, and potential need for escalation of respiratory support or NICU admission.

Existing studies regarding POC LUS as a predictor of need for respiratory support have focused primarily on either extremely or moderately premature or term infants, showing that three different scoring systems have been effective in predicting need for future respiratory support. Some studies have included late preterm infants, but this population reflected only a small portion of total study participants, and others did not include them at all. Given that late preterm neonates are a unique and at-risk population, the paucity of data in the existing knowledge presents a gap that should be addressed.

This study proposes conducting a prospective observational study that focuses on late preterm infants, which will assess whether the existing POC LUS scoring methodologies are useful in this population and will compare the efficacy of these scoring systems. It is proposed to recruit any infant born in the late preterm period who is initially on room air (RA) or nasal cannula (NC), conducting POC LUS and assigning scores per each of the three scoring systems, and assessing their respective predictive values for respiratory decompensation/escalation of support.

Interventions

  • Diagnostic test 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 measures

  • 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.]
Secondary outcome measures (3)
  • Correlation between POC LUS and the timing of signs of respiratory distress [Time frame: 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. [Time frame: 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. [Time frame: 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.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Hackensack Univeristy Medical Center — Hackensack

Publications

  • 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
  • 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
  • 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
  • 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
  • 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

Identifiers

NCT: NCT07216053 · Pro2025-0102

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗