Pediatr Res. 2025 Aug 2. doi: 10.1038/s41390-025-04310-8. Online ahead of print.
ABSTRACT
BACKGROUND: 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.
METHODS: 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).
RESULTS: 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.
CONCLUSIONS: 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.
IMPACT: 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.
PMID:40753114 | DOI:10.1038/s41390-025-04310-8
