NCT05609877View on ClinicalTrials.gov

The NONA-LISA Trial

NARecruitingINTERVENTIONAL
Enrollment

324

Participants

Timeline

Start Date

June 1, 2024

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2029

Conditions
Respiratory Distress Syndrome in Premature Infant
Interventions
DRUG

Isotonic saline

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

PROCEDURE

Less Invasive Surfactant Administration (LISA)

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

DRUG

Fentanyl

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

BEHAVIORAL

Non-pharmacological standard operating procedure

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

Trial Locations (4)

2100

RECRUITING

Department of Neonatal and Pediatric Intensive Care, Blegdamsvej 9, Copenhagen

5000

NOT_YET_RECRUITING

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

8200

RECRUITING

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

9000

WITHDRAWN

Neonatalafsnittet, Børn- og Ungeafdelingen, Reberbansgade 15, Aalborg

All Listed Sponsors
lead

Rigshospitalet, Denmark

OTHER