Minimally invasive surfactant treatment for preterm infants
Prophylactic Minimally Invasive Surfactant Evaluation
This study is testing if giving a special lung treatment right after birth using a gentle method can help very premature babies breathe better compared to waiting until they need extra oxygen.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | N/A to 15 Minutes |
| Sex | All |
| Sponsor | Endeavor Health Academic / other |
| Locations | 1 site (Evanston, Illinois) |
| Trial ID | NCT06007547 on ClinicalTrials.gov |
What this trial studies
This study investigates whether administering exogenous surfactant prophylactically in the delivery room using a minimally invasive technique can improve outcomes for preterm infants born between 22 and 29 weeks of gestation. It is a multicenter, randomized, controlled trial comparing this approach to rescue treatment administered if the infant requires additional oxygen support shortly after birth. The trial will involve several hospitals, with Northshore Evanston Hospital as the primary site, and aims to enroll infants who meet specific gestational age criteria while excluding those with congenital anomalies or alternative causes of respiratory distress.
Who should consider this trial
Good fit: Ideal candidates are inborn preterm infants between 22 0/7 and 29 6/7 weeks' gestation.
Not a fit: Patients who require emergent intubation in the delivery room will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve respiratory outcomes for extremely premature infants.
How similar studies have performed: Previous studies have shown promise with similar minimally invasive surfactant therapies, suggesting potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Gestational age \<30 weeks * Antenatal consent from Parent Exclusion Criteria: * Congenital anomalies * Alternate cause of respiratory distress
Where this trial is running
Evanston, Illinois
- Northshore University Healthsystem — Evanston, Illinois, United States (Recruiting)
Study contacts
- Principal investigator: Matthew Derrick, MBBS — Northshore Univ Healthsystem
- Study coordinator: Matthew Derrick, MBBS
- Email: mderrick@northshore.org
- Phone: 8475702920
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.