NCT06074380 Non Inferiority Trial Investigating Surfactants Administered Via MIST
| NCT ID | NCT06074380 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Endeavor Health |
| Condition | Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 262 participants |
| Start Date | 2024-01-01 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 262 participants in total. It began in 2024-01-01 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
RESEARCH DESIGN Multicenter, randomized, controlled trial. RECRUITMENT Entry 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. Infants who are on NCPAP and FiO2 ≥0.30 will randomized to curosurf or infasurf via MIST. Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress. Babies who require emergent intubation will not be enrolled in the interventions. Parental Consent will be obtained prior to randomization.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06074380 clinical trial?
This trial is open to participants of all sexes, up to 48 Hours, studying Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06074380 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06074380 currently recruiting?
Yes, NCT06074380 is actively recruiting participants. Contact the research team at mderrick@northshore.org for enrollment information.
Where is the NCT06074380 trial being conducted?
This trial is being conducted at Evanston, United States.
Who is sponsoring the NCT06074380 clinical trial?
NCT06074380 is sponsored by Endeavor Health. The trial plans to enroll 262 participants.