Predictive Value of Lung Ultrasound for Respiratory Decompensation in Late Preterm Neonates
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age34-36
SponsorHackensack Meridian Health
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Inborn infants born between 34w0d and 36w6d gestational age are admitted to the NICU or Well Baby Nursery.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Point of care lung ultrasound
Diagnostic testPoint-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established scoring systems
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Point of care lung ultrasound1 intervention
Trial outcomes
Primary outcomes
1
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.
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.2
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.
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 outcomes
1
Correlation between POC LUS and the timing of signs of respiratory distress
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).
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.2
Correlation between POC LUS and the severity of respiratory distress as determined by the length of support needed.
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).
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.3
Correlation between POC LUS and the severity of respiratory distress as determined by the need for invasive respiratory support.
Determine if severity of POC LUS score correlates with the need for invasive versus non-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.Sponsors and contacts
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Source ClinicalTrials.gov