Can non-pharmacological comfort care replace fentanyl in LISA? The NONA-LISA feasibility study.

Abstract

Optimal comfort strategies in LISA remain unclear. This study aimed to evaluate the feasibility of a standardised approach to non-pharmacological comfort care guided by the COMFORTneo score in infants randomised to receive fentanyl or saline as premedication for LISA. Infants born before 30 weeks' gestation were randomised to receive isotonic saline or fentanyl 0.5-1 mcg/kg intravenously as premedication for LISA. Both groups received standardised non-pharmacological comfort care. The outcomes were a modified COMFORTneo score ≥14 during the procedure, need for open-label fentanyl administration during the procedure, and inclusion rate using deferred consent. The NONA-LISA trial was registered on clinicaltrials.gov (NCT05609877). From September 2023 to May 2024, 17 infants were randomised (median gestational age, 28 weeks; 77% male); eight received fentanyl and nine received saline. Modified COMFORTneo score ≥14 occurred in 4/8 (fentanyl) and 3/9 (saline), and most cases were alleviated with improved non-pharmacological comfort care only. Two infants (saline) received open-label fentanyl. Performing LISA with saline and standardised non-pharmacological comfort care guided by the modified COMFORTneo score was feasible. Pausing the procedure and improving non-pharmacological comfort care was sufficient in most cases with a modified COMFORTneo score ≥14 regardless of whether fentanyl or saline was used. The Less Invasive Surfactant Administration (LISA) relies on regular spontaneous breathing to be effective. Analgesic or sedating premedication and a painful or uncomfortable stimulus can cause hypoventilation, which may prevent the LISA method from achieving its full potential. This feasibility study assesses if standardised non-pharmacological comfort care guided by the modified COMFORTneo score is feasible during LISA. Performing LISA with saline and standardised non-pharmacological comfort care guided by the modified COMFORTneo score is feasible and safe. It is possible to blind the use of premedication, and inclusion via deferred consent is feasible.