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.
Who can participate
Age range
0 Hours – 6 Hours
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 requir…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Need for endotracheal intubation within the first 72 hours of life