Comparing non-pharmacological and analgesic approaches for surfactant treatment in premature infants
NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial
This study is testing if using a non-drug approach during surfactant treatment helps premature infants breathe better compared to using pain relief medication.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 324 (estimated) |
| Ages | 24 Weeks to 30 Weeks |
| Sex | All |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 4 sites (Aalborg and 3 other locations) |
| Trial ID | NCT05609877 on ClinicalTrials.gov |
What this trial studies
The NONA-LISA trial is a multicentre, pragmatic, parallel-group, blinded randomized controlled trial conducted at four university hospitals in Denmark. It aims to compare the effectiveness of Less Invasive Surfactant Administration (LISA) using a non-pharmacological approach versus LISA combined with routine analgesic treatment in premature infants born between 24 and 29 weeks of gestation. A total of 324 infants will be enrolled over 36 months, with the primary outcome being the rate of LISA failure, defined as the need for positive pressure ventilation within 24 hours after the procedure. The study seeks to determine if avoiding pre-procedure analgesia can improve outcomes for these vulnerable infants.
Who should consider this trial
Good fit: Ideal candidates for this study are premature infants born at 24+0 to 29+6 weeks of gestation who require surfactant treatment for respiratory distress syndrome.
Not a fit: Patients who have major congenital anomalies or have been intubated prior to randomization will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the respiratory outcomes of premature infants by optimizing surfactant administration techniques.
How similar studies have performed: Other studies have shown promise in optimizing surfactant administration techniques, but this specific approach is novel.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Aalborg and 3 other locations
- Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15 — Aalborg, Denmark (Withdrawn)
- Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit — Aarhus, Denmark (Recruiting)
- Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9 — Copenhagen, Denmark (Recruiting)
- H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60 — Odense, Denmark (Not_yet_recruiting)
Study contacts
- Principal investigator: Niklas Breindahl, MD — Rigshospitalet, Denmark
- Study coordinator: Lise Aunsholt, MD, PhD
- Email: lise.aunsholt@regionh.dk
- Phone: +4561991137
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.