Prophylactic Minimally Invasive Surfactant Evaluation

RESEARCH DESIGN Multicenter, randomized, controlled trial.

Northshore Evanston Hospital will be the primary site. It is hoped that Northwest Community, University of Chicago, Edwards Hospital, Advocate Park Ridge, Advocate Oak Lawn and Advocate Illinois Masonic will also join the study.

RECRUITMENT Entry criteria Inborn preterm infants 22 0/7-29 6/7 weeks' gestation, with be randomized to prophylactic Minimally Invasive Surfactant Therapy (MIST) in the delivery room compared to rescue MIST if fraction of inspired oxygen (FiO2) ≥0.30 at less than 48 hours of age. Babies in both groups will be managed on nasal continuous positive airway pressure (NCPAP) pressures of 5-8 cm water.

Exclusion criteria Infants will be excluded if there is a congenital anomaly or an alternative cause for respiratory distress.

Babies who require emergent intubation in the delivery room will not be enrolled in the interventions.

Parental Consent will be obtained prior to birth. Once delivery is imminent infant will be randomized to immediate versus rescue surfactant administration via MIST. Randomization will be in blocks of 6 and using cards with created by a web based randomizer.

Infants who require emergent intubation in the delivery room will not be enrolled in the interventions but their clinical outcomes will be assessed the same as the babies who receive the intervention.

There will be three gestational age strata (22-23 weeks, 24-26 weeks and 27-29 weeks). Twins and higher order multiples will be randomized independently. Babies in the lowest gestational age strata will not be enrolled at a center until 5 babies at that center have been enrolled in either of the other groups.

INTERVENTION Infants randomized to prophylactic surfactant treatment will receive a dose of poractant alfa (Curosurf) administered under direct laryngoscopy using a surfactant instillation catheter (MIST) 16 Gauge Angiocath (Becton Dickinson, Sandy, UT, USA), at a dosage of 200 mg/kg as soon as possible after delivery (within 15 minutes). The infants will be stabilized and placed on NCPAP or High flow Nasal Cannula (HFNC).

Briefly the MIST procedure is as follows: the angiocath is inserted to an appropriate depth under direct laryngoscopy, the laryngoscope is removed, a carbon dioxide (CO2) detector is placed on the end of the catheter with a endotracheal tube adaptor. If the color changes then adaptor and detector are removed and the surfactant is instilled over about 1 minute and the catheter is removed. The infant is maintained on NCPAP/HFNC during the procedure.