The NONA-LISA Trial
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Respiratory Distress Syndrome in Premature Infant
In brief
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.
Key facts
- Study ID
- NCT05609877
- Run by
- Rigshospitalet, Denmark
- People needed
- 324
- Starts
- 2024-06-01
- Expected to finish
- 2029-05-31
- Last updated by the study team
- 2024-09-20
Who can join
Age: 0 and older, up to 1. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Infants born at one of the trial sites with a gestational age of 24+0 to 29+6 weeks and meeting the criteria for first-choice surfactant treatment by LISA as described by Sweet et al.: worsening babies with RDS and FiO2 > 0.30 on CPAP pressure ≥6 cm H2O.
You may not qualify if…
- suspicion of lung hypoplasia,
- endotracheal intubation at any time before randomisation,
- suspicion of pneumothorax, pulmonary haemorrhage or pleural effusion before LISA,
- major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT).
Where it is running
- Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit — Aarhus, Denmark (enrolling)
- Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9 — Copenhagen, Denmark (enrolling)
- Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15 — Aalborg, Denmark
- H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60 — Odense, Denmark
Full record on ClinicalTrials.gov
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