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Clinical Trials/NCT06446453
NCT06446453
Recruiting
Not Applicable

Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure

Connecticut Children's Medical Center1 site in 1 country52 target enrollmentJune 25, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Respiratory Distress Syndrome, Newborn
Sponsor
Connecticut Children's Medical Center
Enrollment
52
Locations
1
Primary Endpoint
Oxygen Saturation Index
Status
Recruiting
Last Updated
11 months ago

Overview

Brief Summary

Point-of-care ultrasound (POCUS) is the use of ultrasound by the bedside provider in real time to answer a specific question and guide medical management. POCUS can be used to diagnose the severity of neonatal respiratory distress syndrome (RDS) through a lung ultrasound score. Lung ultrasound scores have also been shown to predict if an infant is treated with an initial dose of surfactant. Therefore, using lung ultrasound scores to guide surfactant therapy for RDS will likely lead to earlier surfactant therapy and may improve short-term respiratory outcomes. This study will test this theory by comparing lung ultrasound score-guided surfactant therapy for premature infants with RDS with our current surfactant administration guidelines.

Registry
clinicaltrials.gov
Start Date
June 25, 2024
End Date
June 2026
Last Updated
11 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jacob

Neonatal-Perinatal Fellow

Connecticut Children's Medical Center

Eligibility Criteria

Inclusion Criteria

  • The infant's parent/legal guardian can understand and willingly sign a written informed consent document for this study
  • Birth gestational age between 27w0d-36w6d
  • Diagnosis of respiratory failure secondary to RDS requiring respiratory support with non-invasive positive pressure ventilation

Exclusion Criteria

  • Unable to obtain lung ultrasound between 1-2 hours of life
  • Infants already intubated or received surfactant before the point of care lung ultrasound
  • Infants born with congenital cardiac disease, congenital lung disease, or congenital facial/airway malformations
  • Infants born with chromosomal abnormalities
  • Infants with APGARs ≤ 5 at 10 minutes of life
  • Infants requiring cardiopulmonary resuscitation or therapeutic hypothermia in the first 6 hours of life

Outcomes

Primary Outcomes

Oxygen Saturation Index

Time Frame: At 24 hours of life.

(CPAP Level x FiO2)/(SpO2)

Secondary Outcomes

  • Oxygen Saturation Index(At 48 and 72 hours of life.)

Study Sites (1)

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