Comparing calfactant and poractant alfa delivered by a less invasive catheter to treat respiratory distress in very preterm infants

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.