Investigating surfactants for treating respiratory distress in preterm infants
Non Inferiority Trial Investigating Surfactants Administered Via MIST
This study is testing whether two different surfactants can help preterm infants with breathing problems feel better without needing a breathing tube.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 262 (estimated) |
| Ages | N/A to 48 Hours |
| Sex | All |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT06074380 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized, controlled trial aims to evaluate the effectiveness of surfactants administered via a minimally invasive surfactant therapy (MIST) approach in preterm infants diagnosed with respiratory distress syndrome. Eligible infants, aged 28-35 weeks gestation and less than 48 hours old, will be randomized to receive either calfactant (Infasurf) or poractant alfa (Curosurf) while on nasal continuous positive airway pressure (NCPAP) and requiring a minimum of 30% oxygen. The study will assess the outcomes of these interventions in managing respiratory distress without the need for intubation. Parental consent will be obtained prior to randomization.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants between 28 and 35 weeks of gestation who are less than 48 hours old and diagnosed with respiratory distress syndrome.
Not a fit: Patients who may not benefit from this study include those with congenital anomalies or alternative causes for respiratory distress, as well as those requiring emergent intubation.
Why it matters
Potential benefit: If successful, this approach could improve respiratory outcomes in preterm infants with respiratory distress syndrome, potentially reducing the need for intubation.
How similar studies have performed: Other studies have shown promise in using surfactants for respiratory distress syndrome, but this specific MIST approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Preterm infants 28-35 6/7 weeks' gestation and less than 48 hours of age who have a clinical diagnosis of respiratory distress syndrome confirmed by a chest x-ray on nasal continuous positive airway pressure (NCPAP) and FiO2 ≥0.30 Exclusion Criteria: * Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. * Infants who require emergent intubation will not be enrolled in the interventions.
Where this trial is running
Evanston, Illinois
- Northshore University Healthsystem — Evanston, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Matthew Derrick
- Email: mderrick@northshore.org
- Phone: 18475702920
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.