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NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial

Pediatric Research (2024)Cite this article

Surfactant administration for respiratory distress syndrome (RDS) in premature infants has been the standard of care for over the last three decades. While there is much debate on what, when, and how to administer the surfactant, the general consensus in USA has recently provided practical guidance for surfactant administration.1 Noninvasive ventilation (NIV) provided through continuous positive airway pressure (CPAP) or other NIV modes remain the priority in providing respiratory support for the preterm infants. Even the short duration of providing positive pressure ventilation through any invasive method puts these infants at risk for developing bronchopulmonary dysplasia (BPD). Meta-analyses of delivering surfactant via less invasive surfactant administration (LISA) method has shown superiority over more traditional approach with intubation surfactant and extubation (INSURE) especially in avoiding invasive mechanical ventilation and risk for severe intraventricular hemorrhage. Additionally, LISA method has been shown to result in less BPD and or death.2 With increasing use of LISA technique to administer surfactant, there has been much debate about the use of medications prior to the procedure. Some experts have been routinely using fentanyl while others are reluctant to use such a medication which may potentially lead to complications such as bradycardia, desaturations, and frozen chest.3

In the current issue of Pediatric Research, Breindahl et al. present a protocol for NON-pharmacological Approach to Less Invasive Surfactant Administration (NONA-LISA) clinical trial.4 This is a prospective multicenter, blinded, randomized controlled clinical trial comparing premedication for LISA procedure in preterm infants less than 30 weeks of gestational age. The clinical trial will be initiated at multiple Danish level III neonatal intensive care units (NICU) and enroll 324 infants. The infants will be randomized 1:1 in two groups to receive either intravenous fentanyl 0.5–1 mcg/kg (fentanyl group) or isotonic saline (saline group) prior to LISA procedure. The clinical trial will only include preterm infants receiving surfactant via LISA method for the first time with a diagnosis of RDS and needing FiO2 > 0.30 while receiving CPAP pressure ≥6 cm H2O. Intubated infants, infants with pulmonary hypoplasia, other pulmonary complications prior to surfactant administration, and congenital anomalies will be excluded.

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Authors and Affiliations

  1. Professor of Pediatrics, Division of Neonatology, Cedars Sinai Guerin Children’s, Cedars Sinai Medical Center, Los Angeles, California, 90048, USA

    Rangasamy Ramanathan & Manoj Biniwale

  2. Division of Neonatology, Cedars Sinai Guerin Children’s, Cedars Sinai Medical Center, Los Angeles, USA

    Manoj Biniwale

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  1. Rangasamy Ramanathan
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  2. Manoj Biniwale
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Correspondence to Rangasamy Ramanathan.

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Ramanathan, R., Biniwale, M. NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) trial: protocol for a randomised controlled trial. Pediatr Res (2024). https://doi.org/10.1038/s41390-024-03263-8

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