Using ultrasound to guide surfactant therapy for preterm infants with breathing difficulties
Echography-guided Surfactant THERapy (ESTHER) For Preterm Infants With Respiratory Failure
This study is testing if using ultrasound to help give surfactant treatment can improve breathing for preterm infants with respiratory problems compared to the usual methods.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 52 (estimated) |
| Ages | 0 Hours to 2 Hours |
| Sex | All |
| Sponsor | Connecticut Children's Medical Center Academic / other |
| Locations | 1 site (Hartford, Connecticut) |
| Trial ID | NCT06446453 on ClinicalTrials.gov |
What this trial studies
This study investigates the use of point-of-care ultrasound (POCUS) to assess the severity of respiratory distress syndrome (RDS) in preterm infants and guide surfactant therapy. By employing lung ultrasound scores, the study aims to determine if earlier surfactant administration can improve respiratory outcomes compared to standard treatment protocols. The trial will compare the effectiveness of ultrasound-guided surfactant therapy against current guidelines in a neonatal intensive care setting.
Who should consider this trial
Good fit: Ideal candidates are preterm infants born between 27 and 36 weeks of gestation who are experiencing respiratory failure due to RDS and require non-invasive ventilation.
Not a fit: Patients who are already intubated, have received surfactant prior to the ultrasound, or have significant congenital abnormalities may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved respiratory outcomes for preterm infants suffering from respiratory distress syndrome.
How similar studies have performed: While the use of ultrasound in neonatal care is gaining traction, this specific approach to guiding surfactant therapy is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hartford, Connecticut
- Connecticut Children's — Hartford, Connecticut, United States (Recruiting)
Study contacts
- Principal investigator: Jacob Kelner — Connecticut Children's
- Study coordinator: Jacob Kelner
- Email: jkelner@connecticutchildrens.org
- Phone: 860-545-9720
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.