NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial
Research output: Contribution to journal › Journal article › Research › peer-review
Standard
NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial : protocol for a randomised controlled trial. / Breindahl, Niklas; Henriksen, Tine Brink; Heiring, Christian; Bay, Emma Therese; Haaber, Jannie; Salmonsen, Tenna Gladbo; Carlsen, Emma Louise Malchau; Zachariassen, Gitte; Agergaard, Peter; Viuff, Anne Cathrine Finnemann; Bender, Lars; Grønnebæk Tolsgaard, Martin; Aunsholt, Lise.
In: Pediatric Research, 2024.Research output: Contribution to journal › Journal article › Research › peer-review
Harvard
APA
Vancouver
Author
Bibtex
}
RIS
TY - JOUR
T1 - NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial
T2 - protocol for a randomised controlled trial
AU - Breindahl, Niklas
AU - Henriksen, Tine Brink
AU - Heiring, Christian
AU - Bay, Emma Therese
AU - Haaber, Jannie
AU - Salmonsen, Tenna Gladbo
AU - Carlsen, Emma Louise Malchau
AU - Zachariassen, Gitte
AU - Agergaard, Peter
AU - Viuff, Anne Cathrine Finnemann
AU - Bender, Lars
AU - Grønnebæk Tolsgaard, Martin
AU - Aunsholt, Lise
N1 - Publisher Copyright: © 2024, The Author(s).
PY - 2024
Y1 - 2024
N2 - Introduction: Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA. Methods: The 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. Discussion: The 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. Impact: Pre-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.
AB - Introduction: Using pre-procedure analgesia with the risk of apnoea may complicate the Less Invasive Surfactant Administration (LISA) procedure or reduce the effect of LISA. Methods: The 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. Discussion: The 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. Impact: Pre-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.
U2 - 10.1038/s41390-023-02998-0
DO - 10.1038/s41390-023-02998-0
M3 - Journal article
C2 - 38200325
AN - SCOPUS:85182152571
JO - Pediatric Research
JF - Pediatric Research
SN - 0031-3998
ER -
ID: 381890264