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.
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.
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).
Parallel
Poractant alfa
DrugPoractant 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
DrugCalfactant 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)
Need for endotracheal intubation within the first 72 hours of life
The need for endotracheal intubation within the first 72 hours of life in preterm infants born at 24 1/7-29 6/7 weeks' gestation receiving calfactant or poractant alfa via LISA.
Need for Repeat Surfactant Administration
The requirement for repeat doses of surfactant after the initial LISA procedure in preterm infants treated with calfactant or poractant alfa.
Adverse Events During Surfactant Administration
The occurrence of adverse events during surfactant administration via LISA, including apnea, bradycardia, oxygen desaturation, surfactant reflux, coughing, laryngospasm, and vomiting.
Bronchopulmonary dysplasia
The incidence of bronchopulmonary dysplasia at 36 weeks' postmenstrual age in preterm infants receiving calfactant or poractant alfa via LISA.
Retinopathy of Prematurity
The incidence of retinopathy of prematurity (ROP) in preterm infants receiving calfactant or poractant alfa via LISA.
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