Actively Recruiting
The NONA-LISA Trial
Led by Rigshospitalet, Denmark · Updated on 2024-09-20
324
Participants Needed
4
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
The NONA-LISA Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at one of the trial sites with a gestational age of 24+0 to 29+6 weeks
- Worsening respiratory distress syndrome with FiO2 > 0.30 on CPAP pressure 6 cm H2O
- Meeting criteria for first-choice surfactant treatment by LISA as described by Sweet et al.
You will not qualify if you...
- Suspected lung hypoplasia
- Endotracheal intubation at any time before randomisation
- Suspected pneumothorax, pulmonary haemorrhage, or pleural effusion before LISA
- Major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT)
AI-Screening
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Trial Site Locations
Total: 4 locations
1
Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15
Aalborg, Denmark, 9000
Withdrawn
2
Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit
Aarhus, Denmark, 8200
Actively Recruiting
3
Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9
Copenhagen, Denmark, 2100
Actively Recruiting
4
H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60
Odense, Denmark, 5000
Not Yet Recruiting
Research Team
L
Lise Aunsholt, MD, PhD
CONTACT
N
Niklas Breindahl, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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