Sedation during minimal invasive surfactant therapy: a randomised controlled trial.

BACKGROUND AND AIMS: Although sedation for endotracheal intubation of infants is widely adopted, there is no consensus whether sedation should be used for minimal invasive surfactant therapy (MIST). We compared, in a randomised controlled setting, the level of stress and comfort of preterm infants during MIST with and without receiving low-dose sedation.
METHODS: Infants between 26 and 36 weeks gestational age were randomised to receive either low-dose sedation (1 mg/kg propofol intravenous) or no premedication during MIST procedure. Standard comfort care was given in both groups, which consisted of administering sucrose in the cheek pouch of the infant and containment. Primary end point was the percentage of infants assessed to be comfortable during the procedure (COMFORTneo-score <14). Secondary parameters included complications of both the MIST procedure and low-dose sedation administration.
RESULTS: In total, 78 infants were randomised and analysed, with a median (IQR) gestational age of 29+0 (28+0-32+0) weeks. The percentage of infants with a COMFORTneo score <14 during MIST was significantly higher in the sedated group (32/42 (76%) vs 8/36 (22%), p<0.001). The incidence of desaturation (SpO2 <85%) during the procedure was significantly higher in the sedated group (38/42 (91%) vs 25/36 (69%), p=0.023), and infants needed more often nasal intermittent mandatory ventilation during the procedure (39/42 (93%) vs 17/36 (47%), p<0.001). There were no differences in incidence of hypotension, bradycardia, intubation or pneumothoraxes.
CONCLUSION: Low-dose sedation increased comfort during MIST procedure in preterm infants, but the need for transient non-invasive ventilation was increased. TRIAL REGISTRATION NUMBER: NTR5010, pre-results. © Author(s) (or their employer(s)) 2019. No commercial re-use. See rights and permissions. Published by BMJ.

RCT Entities:   Population Interventions Outcomes