Health Trials

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 groups

Locations

4
Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 159000, Aalborg Denmark
Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit8200, Aarhus Denmark
Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 92100, Copenhagen Denmark
H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 605000, Odense Denmark

Sponsors and collaborators

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov