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

Recruiting

• Conditions: Pre-Term; Respiratory Distress of Newborn; Premature

• Registration Number: NCT07216053
• Lead Sponsor: Hackensack Meridian Health

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.

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.

Study Timeline

• Study First Submitted: 2025-10-09
• Study First Submitted QC: 2025-10-10
• Study First Posted: 2025-10-14
• Status Verified: 2025-11
• Study Start: 2025-11-06
• Last Update Submitted: 2025-11-06
• Last Update Posted: 2025-11-10
• Primary Completion: 2027-11
• Study Completion: 2027-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of POC LUS scoring systems to predict respiratory decompensation in late preterm infants.	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.	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.
Compare the predictive accuracy of the three scoring systems	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.	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.

Secondary Outcome Measures

Name	Time	Method
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.	Determine if severity of POC LUS score correlates with onset of respiratory decompensation (i.e. does a worse LUS score correlate with earlier onset of respiratory decompensation).
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.	Determine if severity of POC LUS score correlates with the length of time infant requires respiratory support in the form of HFNC, CPAP, NIMV or mechanical ventilation (i.e. does a worse LUS score correlate with earlier onset of respiratory decompensation).
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.	Determine if severity of POC LUS score correlates with the need for invasive versus non-invasive respiratory support.

Trial Locations

Locations (1)

Hackensack Univeristy Medical Center; 🇺🇸 Hackensack, New Jersey, United States