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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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

Первичные конечные точки

• Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants. [Срок оценки: 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 [Срок оценки: 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.]

Вторичные конечные точки (3)

• Correlation between POC LUS and the timing of signs of respiratory distress [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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.]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Hackensack Univeristy Medical Center — Hackensack

Публикации

• 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

Идентификаторы

NCT: NCT07216053 · Pro2025-0102

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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