Premedication practices for less invasive surfactant administration — results from a nationwide cohort study

Abstract

Background and aims

There are no established premedication schemes for less invasive surfactant administration (LISA) in neonatal RDS. The aim was to describe "real-world" practices and to assess the safety of premedication and its impact on the technical ease of the LISA procedure.

Methods

Data from the prospective LISA cohort study conducted in 31 tertiary neonatal units were evaluated for premedication practices. Infants who received analgesics and/or sedatives before LISA and those receiving non-pharmacological sedation with sublingual 30% glucose were compared versus nonpremedicated neonates, acting as a reference. Safety of premedication was assessed with the rate of adverse events during LISA, changes in oxygenation status, the need for rescue intubation, and mechanical ventilation in the first 24 h of life. Ease of conducting LISA was an efficacy endpoint.

Results

Of 500 enrolled newborns, 102 (20.4%) received premedication for LISA; 88 infants were given analgesics/sedatives and 14 sublingual glucose. Pharmacological sedation was most often performed with ketamine (51/88; 57.9%), midazolam (16/88; 18.2%) and propofol (8/88; 1.6%). Compared to non-premedication, the use of analgesics/sedatives was associated with a significant increase in the rate of apnea (9.1 vs 2.6%; p = 0.009) and a significantly higher decrease in SpO₂/FiO₂ (−55 ± 62 vs −32 ± 50; p < 0.001). However, the rates of rescue intubation and the need for early mechanical ventilation were not significantly different. Sedation with glucose did not affect the frequency of adverse events. LISA procedures had a similar level of ease regardless of the premedication used and were rated as easy or very easy in 69% of non-premedicated infants, 65.9% of the analgesics/sedatives group and 78.5% of the glucose group (p = ns).

Conclusion

Analgesics/sedatives prior to LISA increased the rate of apnea and decreased blood oxygenation but did not lead to tracheal intubation and early mechanical ventilation. Trials addressing the impact on LISA-related stress are necessary to determine the ultimate usefulness of premedication.

Keywords:

• Preterm infant
• sedation
• premedication
• surfactant
• less invasive

Acknowledgments

The authors wish to thank all the investigators who collected the data that were presented in this analysis.

Disclosure statement

No potential conflict of interest was reported by the author(s). P. Krajewski received honoraria from Chiesi Poland for scientific presentations and participation on advisory boards. D. Szpecht received compensation from Chiesi Poland as site investigator for this study. R. Hożejowski is employed by Chiesi Poland, the sponsor of the study.

Additional information

Funding

This study was supported by Chiesi Poland, a subsidiary of Chiesi Farmaceutici, Italy.