Comparing two methods of surfactant administration in preterm infants with respiratory distress
Comparison of "IN-REC-SUR-E" and LISA in Preterm Neonates With Respiratory Distress Syndrome: a Randomized Controlled Trial (IN-REC-LISA Trial)
This study is testing two different ways to give surfactant to preterm babies with breathing problems to see which method helps them survive better without lung complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 381 (estimated) |
| Ages | 24 Weeks to 27 Weeks |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT05711966 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of two surfactant administration techniques, INtubate-RECruit-SURfactant-Extubate (IN-REC-SUR-E) and Less Invasive Surfactant Administration (LISA), in preterm infants suffering from Respiratory Distress Syndrome (RDS). The primary hypothesis is that the IN-REC-SUR-E method, which includes a recruitment maneuver before surfactant delivery, will improve survival rates without bronchopulmonary dysplasia (BPD) at 36 weeks' gestational age compared to LISA. The study will enroll infants born between 24 and 27 weeks' gestation who are failing non-invasive respiratory support within the first 24 hours of life. Written parental consent will be required for participation.
Who should consider this trial
Good fit: Ideal candidates for this study are preterm infants born at 24+0 to 27+6 weeks' gestation who are breathing independently but failing nasal CPAP or NIPPV.
Not a fit: Patients with severe birth asphyxia, major congenital abnormalities, or those who have been intubated prior to the study will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved survival rates and reduced incidence of BPD in extremely preterm infants.
How similar studies have performed: Previous studies have shown promising results with similar surfactant administration techniques, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Infants satisfying the following inclusion criteria will be eligible to participate: 1. Born at 24+0-27+6 in a tertiary neonatal intensive care unit participating in the trial (and) 2. Breathing independently and sufficiently with only nasal CPAP or NIPPV for respiratory support (and) 3. Written parental consent has been obtained (and) 4. Failing nasal CPAP or NIPPV during the first 24 hours of life Exclusion Criteria: 1. Severe birth asphyxia or a 5-minute Apgar score less than 3 2. Prior endotracheal intubation for resuscitation or insufficient respiratory drive 3. Prolonged (\>21 days) premature rupture of membranes 4. Presence of major congenital abnormalities 5. Hydrops fetalis 6. Inherited disorders of metabolism
Where this trial is running
Roma
- Fondazione Policlinico Agostino Gemelli IRCCS — Roma, Italy (Recruiting)
Study contacts
- Study coordinator: Giovanni Vento, MD
- Email: giovanni.vento@unicatt.it
- Phone: +39 0630153237
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.