| NCT ID | NCT05609877 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Rigshospitalet, Denmark |
| Condition | Respiratory Distress Syndrome in Premature Infant |
| Study Type | INTERVENTIONAL |
| Enrollment | 324 participants |
| Start Date | 2024-06-01 |
| Primary Completion | 2028-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 324 participants in total. It began in 2024-06-01 with a primary completion date of 2028-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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).
Contact & Investigator
Niklas Breindahl, MD
PRINCIPAL INVESTIGATOR
Rigshospitalet, Denmark
Frequently Asked Questions
Who can join the NCT05609877 clinical trial?
This trial is open to participants of all sexes, aged 24 Weeks or older, up to 30 Weeks, studying Respiratory Distress Syndrome in Premature Infant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05609877 currently recruiting?
Yes, NCT05609877 is actively recruiting participants. Contact the research team at lise.aunsholt@regionh.dk for enrollment information.
Where is the NCT05609877 trial being conducted?
This trial is being conducted at Aalborg, Denmark, Aarhus, Denmark, Copenhagen, Denmark, Odense, Denmark.
Who is sponsoring the NCT05609877 clinical trial?
NCT05609877 is sponsored by Rigshospitalet, Denmark. The principal investigator is Niklas Breindahl, MD at Rigshospitalet, Denmark. The trial plans to enroll 324 participants.