Comparing calfactant and poractant alfa delivered by a less invasive catheter to treat respiratory distress in very preterm infants
Comparison of the Efficacy of Calfactant and Poractant Alfa Surfactants Administered by a Less Invasive Surfactant Administration Technique in Preterm Infants With Respiratory Distress Syndrome
This will see if poractant alfa or calfactant given through a thin catheter (LISA) helps preterm infants under 30 weeks with respiratory distress who are breathing on noninvasive support.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 234 (estimated) |
| Ages | 0 Hours to 6 Hours |
| Sex | All |
| Sponsor | Uludag University Academic / other |
| Locations | 5 sites (Bursa and 4 other locations) |
| Trial ID | NCT07350018 on ClinicalTrials.gov |
What this trial studies
This multicenter, randomized Phase 4 study enrolls infants born before 30 weeks' gestation who develop respiratory distress syndrome and are receiving noninvasive respiratory support. Enrolled infants will receive either poractant alfa or calfactant administered via the Less Invasive Surfactant Administration (LISA) technique through a thin catheter while they breathe spontaneously. The trial compares short-term outcomes including need for intubation, repeat surfactant dosing, and the level of respiratory support required during the first 72 hours of life. Outcomes will determine whether one surfactant provides better early respiratory stability when given by LISA.
Who should consider this trial
Good fit: Ideal candidates are infants born at 24 1/7 to 29 6/7 weeks, within 6 hours of birth, on noninvasive respiratory support with FiO2 >30% at a minimum support pressure of 6 cmH2O, with clinical/radiologic RDS and parental consent.
Not a fit: Infants already intubated before the decision to give surfactant, those with severe birth asphyxia, or major congenital anomalies are excluded and would not be expected to benefit from this protocol.
Why it matters
Potential benefit: If one drug performs better with LISA, babies may avoid intubation and mechanical ventilation and have fewer early respiratory complications.
How similar studies have performed: Less Invasive Surfactant Administration (LISA) has been associated with reduced need for invasive ventilation in prior studies, but direct randomized comparisons of poractant alfa versus calfactant using LISA are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Born at a participating study center hospital. * Gestational age between 24 1/7 and 29 6/7 weeks (\<30 0/7 weeks). * Postnatal age within the first 6 hours of life. * Being on non-invasive respiratory support. * Presence of clinical and radiological findings consistent with respiratory distress syndrome (RDS). * Indication for surfactant therapy defined as a requirement for FiO₂ \>30% to achieve target oxygen saturation (SpO₂ 90-94%) while receiving noninvasive respiratory support with a minimum pressure of 6 cmH₂O. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Infants who were intubated for any reason before the decision to administer surfactant. * Severe birth asphyxia, defined as the need for advanced resuscitation after birth, 10th minute Apgar score ≤5, and arterial blood gas within the first hour of life showing pH \<7.0 and base excess (BE) ≤-12. * Presence of major congenital anomalies. * Respiratory distress due to causes other than respiratory distress syndrome (RDS). * Congenital heart disease. * Congenital diaphragmatic hernia. * Pulmonary hypoplasia. * Chromosomal abnormalities. * Presence of pneumothorax. * Lack of informed consent. * Neonatal seizures presence. * Postnatal age greater than 6 hours. * Infants born outside of gestational weeks 24 1/7 - 29 6/7. * Requirement for invasive mechanical ventilation at enrollment. * Infants receiving noninvasive respiratory support with an FiO₂ requirement \<0.30.
Where this trial is running
Bursa and 4 other locations
- Bursa City Hospital — Bursa, Turkey (Türkiye) (Recruiting)
- Division of Neonatology, Department of Pediatrics, Bursa Uludağ University Faculty of Medicine — Bursa, Turkey (Türkiye) (Recruiting)
- Division of Neonatology, Department of Pediatrics, University of Health Sciences Bursa Yuksek İhtisas Training and Research Hospital — Bursa, Turkey (Türkiye) (Recruiting)
- Dörtçelik Children's Diseases Hospital — Bursa, Turkey (Türkiye) (Recruiting)
- Medicana Bursa Hospital — Bursa, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Salih Çağrı Çakır, Associate professor
- Email: salihcagri@uludag.edu.tr
- Phone: +90 533 3453739
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.