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

Status: Recruiting
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Maximum Age: Newborn
Healthy Volunteers: f
View:

• 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

Locations
United States
Connecticut
Connecticut Children's
RECRUITING
Hartford
Contact Information
Primary
Jacob Kelner
jkelner@connecticutchildrens.org
860-545-9720
Time Frame
Start Date: 2024-06-25
Estimated Completion Date: 2026-06
Participants
Target number of participants: 52
Treatments
No_intervention: Control
The control group will receive surfactant therapy based on our unit's current surfactant guidelines, including but not limited to a FiO2 requirement ≥ 0.3 on non-invasive positive pressure ventilation.
Experimental: Treatment
The treatment group will receive surfactant therapy if the initial LUS at 1-2 hours of life is \> 9 or if they meet our unit's current surfactant therapy guidelines (irrespective of the LUS).
Sponsors
Leads: Connecticut Children's Medical Center

This content was sourced from clinicaltrials.gov