Less Invasive Beractant Administration in Preterm Infants

NACompletedINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

November 30, 2014

Study Completion Date

March 31, 2015

Conditions
Infant, Premature
Interventions
PROCEDURE

LISA

All infants were supported with nCPAP while breathing spontaneously during instillation. A 5Frenchgamma sterilized multi-access catheter specifically designed to deliver surfactants for Neonates was placed 1-2 cm below the vocal cords by direct laryngoscopy without the use of a Magill forceps. Beractant was used as exogenous natural surfactant, (100mg/kg; 4ml/kg) and administered in two aliquots during 1-3 minutes. Positive pressure inflations were given by a mask and bag only if the infant was apneic or bradycardia develops despite the interruption of the procedure. The surfactant administration catheter was removed after surfactant instillation and nCPAP support was maintained. A second dose of surfactant was administered during the first 3 days of life if more than 40% of FiO2 was needed while on nCPAP with at least 6 cm H2O pressure.

PROCEDURE

INSURE

"The INSURE technique was performed using Beractant (4ml/kg) after endotracheal intubation. A multi-access catheter for Neonates/Pediatrics designed to deliver surfactants (KimVentTrach Care Technology ®, United Kingdom) was pre-connected to the endotracheal tube and used for surfactant administration without having to disconnect the ventilator. While surfactant was administered all infants were connected to pressure support ventilation modality (PSV) combined with volume guarantee (VG), Dräger ventilator). A tidal volume of 4ml/kg was initially adjusted.~After surfactant administration, all infants were to be extubated, in accordance with our institutional extubation guidelines, if FiO2\< 0.35; for a target Oxygen Saturation (SpO2) of \>90%, and if a consistent respiratory effort was present. Extubation was supported with nCPAP in all patients."

All Listed Sponsors
lead

Hospital General Universitario Gregorio Marañon

OTHER

NCT02611284 - Less Invasive Beractant Administration in Preterm Infants | Biotech Hunter | Biotech Hunter