Comparing the effectiveness between fentanyl, remifentanil and propofol in preterm newborns undergoing INSURE procedure: a randomized controlled trial

Abstract

Objectives: the aim of this study is to compare the effectiveness of fentanyl, remifentanil and propofol as a premedication for INSURE procedure, to treat preterm newborns suffering from respiratory distress syndrome (RDS) Design: non-placebo controlled, double blind, randomized controlled clinical trial. Setting: multicenter clinical trial, involving 22 centers from Catalonia and Madrid. Hospital Universitari Josep Trueta (Girona) will be the reference center. Participants: preterm newborns, below 32 GW or 1,500 grams of birth weight, suffering from RDS Interventions: patients will be randomized in three groups and each group will receive one of the three premedications. Secondly they will undergo INSURE procedure, response and adverse effects will be recorded. Infants will be followed-up during two years, and long-term effects development will be collected. Main outcome measures: primary outcome measure is the time to succesful extubation. Secondary outcome measures include appearance of complications during the procedure, and development long-term secondary effects