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The NONA-LISA Trial
Sponsor: Rigshospitalet, Denmark
Summary
The NONA-LISA trial will be an investigator-initiated, multicentre, pragmatic, parallel-group, blinded RCT conducted at four university hospitals across Denmark. A total of 324 inborn premature infants will be included within 36 months at four neonatal intensive care units (NICUs) across Denmark (approximately 2 infants per month per unit). The aim is to compare LISA using a non-pharmacological approach alone with routine analgesic treatment combined with a non-pharmacological approach (according to local guidelines) regarding LISA failure defined as the need for positive pressure ventilation for 30 min or more (cumulated) within 24 hours after the procedure in infants born prior to 30 gestational weeks.
Official title: NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial
Key Details
Gender
All
Age Range
24 Weeks - 30 Weeks
Study Type
INTERVENTIONAL
Enrollment
324
Start Date
2024-06-01
Completion Date
2029-05-31
Last Updated
2024-09-20
Healthy Volunteers
No
Interventions
Isotonic saline
Isotonic saline will be administered intravenously instead of pre-procedure analgesia.
Less Invasive Surfactant Administration (LISA)
All infants will be treated with the Less Invasive Surfactant Administration (LISA) procedure
Fentanyl
Fentanyl 0.5-1.0 mcg/kg will be administered intravenously as pre-procedure analgesia
Non-pharmacological standard operating procedure
All infants will receive the same non-pharmacological standard operating procedure.
Locations (4)
Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15
Aalborg, Denmark
Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit
Aarhus, Denmark
Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9
Copenhagen, Denmark
H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60
Odense, Denmark