Article, Early Access,
NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial
Contributors
Breindahl, Niklas
0000-0003-3016-3567
(Corresponding author)
[1]
[2]
Heiring, Christian
0000-0001-5690-3725
[1]
[2]
Zachariassen, Gitte
0000-0003-4440-2362
[4]
[5]
Viuff, A. C.
0000-0002-4850-0616
[6]
[7]
Affiliations
- [1] Copenhagen Univ Hosp, Copenhagen Acad Med Educ & Simulat CAMES, Rigshosp, Copenhagen, Denmark [NORA names: Capital Region of Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
- [2] Copenhagen Univ Hosp, Copenhagen Acad Med Educ & Simulat CAMES, Rigshosp, Copenhagen, Denmark [NORA names: KU University of Copenhagen; University; Denmark; Europe, EU; Nordic; OECD];
- [3] Aarhus Univ Hosp, Dept Clin Med, Perinatal Epidemiol Res Unit, Aarhus, Denmark [NORA names: AU Aarhus University; University; Denmark; Europe, EU; Nordic; OECD];
- [4] Odense Univ Hosp, Hans Christian Andersen Childrens Hosp, Odense, Denmark [NORA names: Region of Southern Denmark; Hospital; Denmark; Europe, EU; Nordic; OECD];
- [5] Odense Univ Hosp, Hans Christian Andersen Childrens Hosp, Odense, Denmark [NORA names: SDU University of Southern Denmark; University; Denmark; Europe, EU; Nordic; OECD];
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Abstract
IntroductionUsing pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA.MethodsThe NONA-LISA trial (ClinicalTrials.gov, NCT05609877) is a multicentre, blinded, randomised controlled trial aiming at including 324 infants born before 30 gestational weeks, meeting the criteria for surfactant treatment by LISA. Infants will be randomised to LISA after administration of fentanyl 0.5-1 mcg/kg intravenously (fentanyl group) or isotonic saline solution intravenously (saline group). All infants will receive standardised non-pharmacological comfort care before and during the LISA procedure. Additional analgesics will be provided at the clinician's discretion. The primary outcome is the need for invasive ventilation, meaning mechanical or manual ventilation via an endotracheal tube, for at least 30 min (cumulated) within 24 h of the procedure. Secondary outcomes include the modified COMFORTneo score during the procedure, bronchopulmonary dysplasia at 36 weeks, and mortality at 36 weeks.DiscussionThe NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice.ImpactPre-procedure analgesia is associated with apnoea and may complicate procedures that rely on regular spontaneous breathing, such as Less Invasive Surfactant Administration (LISA).This randomised controlled trial addresses the effect of analgesic premedication in LISA by comparing fentanyl with a placebo (isotonic saline) in infants undergoing the LISA procedure. All infants will receive standardised non-pharmacological comfort.The NONA-LISA trial has the potential to provide evidence for a standardised approach to relief from discomfort or pain in preterm infants during LISA and to reduce invasive ventilation. The results may affect future clinical practice regarding analgesic treatment associated with the LISA procedure.
