The NONA-LISA Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-30
SponsorRigshospitalet, Denmark
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
Trial design
Treatments tested in this trial
- Isotonic saline
- Less Invasive Surfactant Administration (LISA)
- Fentanyl
- Non-pharmacological standard operating procedure
Treatment groups
324 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov