Hackensack Univeristy Medical Center
Hackensack, New Jersey, 07601, United States
Location status: Recruiting
NCT Number: NCT07216053
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.
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Request Info34 week–36 week
All sexes
Observational
Hackensack, New Jersey, 07601, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Point-of-care lung ultrasound (POC LUS) in their first 4 hours of life and be scored based on three established 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.
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.
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 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).
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.
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.
Determine if severity of POC LUS score correlates with the need for invasive versus non-invasive respiratory support.
Contact information is provided by the study sponsor or research team.
Hackensack Meridian Health
Other
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