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The NONA-LISA Trial

NCT05609877 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 324

Last updated 2024-09-20

No results posted yet for this study

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.

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.

Sponsors & Collaborators

  • Rigshospitalet, Denmark

    lead OTHER

Principal Investigators

  • Niklas Breindahl, MD · Rigshospitalet, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
24 Weeks
Max Age
30 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2028-05-31
Completion
2029-05-31

Countries

  • Denmark

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05609877 on ClinicalTrials.gov