Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome
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
Uludag University
234 participants
Jan 20, 2026
INTERVENTIONAL
Conditions
Summary
Respiratory distress syndrome (RDS) is a common cause of respiratory failure in preterm infants and is frequently treated with surfactant therapy. With the increasing use of noninvasive ventilation, less invasive methods of surfactant administration have been developed. In the technique known as Less Invasive Surfactant Administration (LISA), surfactant is delivered into the trachea through a thin catheter, without the need for endotracheal intubation. This approach may reduce lung injury and improve respiratory outcomes in spontaneously breathing preterm infants. This multicenter, prospective, randomized study aims to compare the clinical effectiveness of poractant alfa and calfactant when administered using the LISA technique in preterm infants born at less than 30 weeks' gestation with RDS who are not intubated. The study will evaluate short-term outcomes, including the need for intubation, repeat surfactant administration, and respiratory support during the first 72 hours of life, as well as longer-term outcomes such as bronchopulmonary dysplasia and other neonatal morbidities.
Eligibility
Inclusion Criteria7
- 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 Criteria15
- 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.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Poractant alfa will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (200 mg/kg initial dose, 100 mg/kg repeat dose)
Calfactant will be administered using the Less Invasive Surfactant Administration (LISA) technique. A thin catheter will be inserted into the trachea under direct laryngoscopic visualization, without the need for endotracheal intubation, while the infant continues to breathe spontaneously on noninvasive respiratory support. Dosing and administration will follow standard clinical guidelines. (100 mg/kg initial and repeat dose)
Locations(5)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07350018