The NONA-LISA Trial

Launched by RIGSHOSPITALET, DENMARK · Nov 1, 2022

Keywords

ClinConnect Summary

The NONA-LISA trial is a research study looking at how to treat respiratory distress syndrome (RDS) in premature infants. Specifically, it is comparing two methods: one using a technique called LISA (a way to help the baby breathe) with no additional pain relief, and the other using LISA along with routine pain relief methods. The goal is to see which approach better helps these infants avoid the need for more intensive breathing support within the first day after treatment.

To be eligible for this trial, infants need to be born between 24 and 29 weeks of pregnancy and must show signs of needing surfactant treatment, which is a common therapy for RDS. The study will include 324 newborns across four hospitals in Denmark over the next three years. Parents can expect that their baby will receive either of the two treatment approaches being studied, and researchers will closely monitor their breathing and overall health. It’s important for families to know that certain conditions, like serious lung problems or major congenital anomalies, would prevent a baby from participating in this trial.

Gender

ALL

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).