Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

Administration of Surfactant Through an Instillation Device Infasurf® (Calfactant) in Neonates- A Pilot Study

A pilot study to explore and determine feasibility and safety of the administration of surfactant through a new supraglottic device in patients from 500 to 5000 grams with RDS.

Surfactant therapy can be life-saving for newborn infants with respiratory distress due to surfactant insufficiency, also known as respiratory distress syndrome (RDS). All commercially available surfactants for clinical use are approved for administration through an endotracheal tube. Placement of an endotracheal tube, a procedure called intubation, is stressful for the infant and associated with significant adverse effects. The proposed supraglottic instillation device allows infants to benefit from surfactant therapy while avoiding the negative effects of intubation.

Patients in this group will have Calfactant at 3ml/kg administered via the supraglottic administration device.

Infants who meet eligibility criteria and have a signed consent form by their parent or guardian will be enrolled in the study. Once enrolled, the surfactant airway device placement and surfactant administration will occur as detailed in the protocol. The infant will be monitored. If the infant meets instillation failure criteria, the procedure will be repeated shortly after the initial procedure. A maximum of two (2) doses will be given during the initial procedure. If the infant meets re-dosing criteria, (s)he may receive up to two (2) additional doses through the surfactant airway device (initial procedure with 1-2 doses and up to two additional doses). If at any time the infant reaches treatment failure criteria, the infant would be intubated and receive a site-specific surfactant through an endotracheal tube. Study outcome data will be followed until discharge from the NICU.

"Treatment failure" defined as requiring intubation and liquid surfactant instillation with or without mechanical ventilation.

Inclusion Criteria: Gestational age at the time of enrollment ≥ 24 0/7 weeks Weight at the time of enrollment 500- 5000 grams Age ≤ 24 hours old Require non-invasive respiratory support (i.e. continuous positive airway pressure, high flow nasal cannula or non-invasive ventilation) Require FiO2 ≤ 40% Clinical diagnosis of RDS Exclusion Criteria: Prior surfactant administration Prior mechanical ventilation Major congenital anomaly Abnormality of the airway Respiratory distress secondary to an etiology other than RDS (suspected pulmonary hypoplasia, pneumothorax, meconium aspiration syndrome, pneumonia, septic or hypovolemia shock, hypoxic ischemic encephalopathy) Apgar score < 5 at 5 minutes of age