A Randomized Controlled Trial in Low-Dose Sedation during Minimal Invasive Surfactant Therapy

Introduction: 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 the level of stress and comfort of preterm infants during MIST with and without receiving low-dose sedation.

Materials and Methods: Infants born between 26 and 36 weeks’ gestational age (GA) were randomized 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 during the procedure. The primary end point was the percentage of infants who were scored to be comfortable during the procedure (COMFORTneo-score  <  14). Secondary study parameters included complications of both the MIST procedure and low-dose sedation administration.

Results: In total, 84 infants were randomized, with a median (interquartile) GA of 29⁺⁰ (28⁺⁰–32⁺⁰) weeks, of which 42 received sedation and 42 did not receive sedation. There were no differences in GA and birth weight between the groups. The percentage of infants with a COMFORTneo score  <  14 during MIST was significantly higher in the sedated group (32 out of 42 (76%) vs. 8 out of 36 (22%), p  <  0.001). The incidence of desaturation (SpO₂  <  85%) during the procedure was significantly higher in the sedated group (38 out of 42 (91%) vs. 25 out of 36 (69%), p = 0.023), and infants needed more often nIMV during the procedure (39 out of 42 [93%] vs. 17 out of 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 more often noninvasive ventilation was temporarily needed.