NCT07350018 Calfactant vs Poractant Alfa Using a Less Invasive Technique in Preterm Infants With Respiratory Distress Syndrome

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You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.

This trial targets 234 participants in total. It began in 2026-01-20 with a primary completion date of 2027-02-20.

Brief 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 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.

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