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

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

Recruiting
34-36 years
All
Phase N/A

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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.

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.

Eligibility

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 details
    Pre-Term
    Respiratory Distress of Newborn
    Premature

NCT07216053

Hackensack Meridian Health

1 February 2026

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