Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
Purpose
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.
Conditions
- Respiratory Distress Syndrome, Newborn
- Pulmonary Surfactants
- Intensive Care Units, Neonatal
Eligibility
- Eligible Ages
- Between 0 Hours and 2 Hours
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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). |
|
Recruiting Locations
Connecticut Children's
Hartford, Connecticut 06106
Hartford, Connecticut 06106
Contact:
Little
Little
More Details
- NCT ID
- NCT06446453
- Status
- Recruiting
- Sponsor
- Connecticut Children's Medical Center