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The NONA-LISA Trial

RecruitingNAAges 24 Weeks - 30 WeeksAllCopenhagen University Hospital, Rigshospitalet
NCT05609877 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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. Exclusion Criteria: 1. suspicion of lung hypoplasia, 2. endotracheal intubation at any time before randomisation, 3. suspicion of pneumothorax, pulmonary haemorrhage or pleural effusion before LISA, 4. major congenital anatomical anomalies as described by the European Surveillance of Congenital Anomalies (EUROCAT).
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What it tests

  • Isotonic saline
  • Less Invasive Surfactant Administration (LISA)
  • Fentanyl
  • Non-pharmacological standard operating procedure
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Where

4 sites
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
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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