RecruitingNot ApplicableNCT05609877

The NONA-LISA Trial

NON-pharmacological Approach Less Invasive Surfactant Administration (NONA-LISA) Trial: Protocol for a Randomised Controlled Trial

Sponsor

Rigshospitalet, Denmark

Enrollment

324 participants

Start Date

Jun 1, 2024

Study Type

INTERVENTIONAL

Conditions

Respiratory Distress Syndrome in Premature Infant

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

Min Age: 24 WeeksMax Age: 30 Weeks

Inclusion Criteria1

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 Criteria4

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).

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Interventions

DRUGIsotonic saline

Isotonic saline will be administered intravenously instead of pre-procedure analgesia.

PROCEDURELess Invasive Surfactant Administration (LISA)

All infants will be treated with the Less Invasive Surfactant Administration (LISA) procedure

DRUGFentanyl

Fentanyl 0.5-1.0 mcg/kg will be administered intravenously as pre-procedure analgesia

BEHAVIORALNon-pharmacological standard operating procedure

All infants will receive the same non-pharmacological standard operating procedure.

Locations(4)

Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15

Aalborg, Denmark

Department of Paediatrics (Intensive Care Neonatology) and Perinatal Research Unit

Aarhus, Denmark

Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9

Copenhagen, Denmark

H.C. Andersen Børne- og Ungehospital, Kløvervænget 23C, Indgang 60

Odense, Denmark

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