Health TrialsbyHealthPanel

The NONA-LISA Trial

ConditionRespiratory Distress Syndrome in Premature Infant
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age24-30
SponsorRigshospitalet, Denmark

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Isotonic saline

    Drug

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

  • Less Invasive Surfactant Administration (LISA)

    Procedure/Surgery

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

  • Fentanyl

    Drug

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

  • Non-pharmacological standard operating procedure

    Behavioral

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

Treatment groups

324 Participants
are divided into 2 treatment groups
Group A: Fentanyl groupActive comparator 3 interventions
Group B: Saline groupSham comparator 3 interventions

Trial outcomes

Primary outcomes

1

LISA failure within 24 hours.

The primary outcome will be LISA failure in terms of the need for endotracheal intubation and mechanical ventilation for at least 30 minutes (cumulated) within 24 hours after the procedure.

Time frame
24 hours after procedure.

Secondary outcomes

1

Incidence of additional fentanyl administration

This will include the number of injection(s), dosage, cumulated dose, and indications defined as pain/discomfort/sedation/other.

Time frame
During the procedure, an average of 5-10 minutes.
2

Pain or discomfort during the procedure (according to COMFORTneo score >14).

This will include a numerical and a categorical variable (COMFORTneo score \>/\< 14).

Time frame
24 hours after procedure
3

Bradycardia <100 BPM for a minimum duration of 4 seconds.

This is a categorical variable (yes/no).

Time frame
24 hours after procedure.
4

Need for a second dose of surfactant

This is a categorical variable (yes/no).

Time frame
24 hours after procedure.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Rigshospitalet, Denmark

Lead sponsor

Source ClinicalTrials.gov
Apply now