Respiratory Effect of the LISA Method With Sedation by Propofol Versus Absence of Sedation.

  • STATUS
    Recruiting
  • End date
    Oct 7, 2024
  • participants needed
    542
  • sponsor
    University Hospital, Grenoble
Updated on 23 January 2021

Summary

The investigators propose to evaluate premedication with Propofol compared to a control strategy including a placebo with a possible rescue treatment with ketamine to ensure pain control before LISA Procedure . Investigators hypothesize that sedation with Propofol is safe and non-inferior to placebo for the risk of Mechanical Ventilation in the 72 hours following the procedure.

Description

Non-inferiority trial comparing Propofol versus placebo during the intra tracheal Less Invasive Surfactant Administration (LISA) in preterm babies < 32 weeks of gestation for the need for mechanical ventilation after the procedure. An open-label ketamine treatment as rescue is possible in each group.

In each participating unit, information will be given to parents of preterm babies <32 wGA upon their admission to the delivery room or to the NICU (neonatal intensive care unit), and informed consent will be sought as soon as possible. Eligible babies presenting a RDS (respiratory distress syndrome) will be included and randomized to the control (placebo) group or Propofol group. While benefiting from Nasal Intermittent Positive Pressure Ventilation (NIPPV) the newborn will be prepared as usual for tracheal intubation. Trialists will be blinded to treatment allocation.

The drug administration in the two groups will be titrated according to weight (0.5mg/kg per dose of Propofol or a similar volume of placebo). After each dose, a pain score (FANS) will be quickly evaluated within 2 minutes of the injection, to assess the need for a supplementary dose (up to a predefined limit) or rescue treatment by Ketamine.

After the steps of sedation, the LISA procedure will be performed, with detailed data collection of per procedure events up to 72 hours of life. Babies will be subsequently managed as usual in each NICU and data will be collected about respiratory, neurological and hemodynamic outcomes during the hospital stay, and especially at discharge, 28 days, and 36 weeks. At two years of corrected age, a final examination will be performed to evaluate neurodevelopmental outcomes.

Details
Condition Respiratory Distress Syndrome in Premature Infant
Treatment placebos, Propofol-Lipuro
Clinical Study IdentifierNCT04016246
SponsorUniversity Hospital, Grenoble
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Gender: Male or Female
Do you have Respiratory Distress Syndrome in Premature Infant?
Do you have any of these conditions: Do you have Respiratory Distress Syndrome in Premature Infant??
Preterm Infants < 32 wGA (weeks of gestational age)
Presenting a RDS (respiratory distress syndrome)
in the first 48 hours of life
treated by CPAP (continuous positive airway pressure) or BiPAP (Bilevel Positive Airway Pressure)
requiring surfactant
FIO2 : (fraction of inspired oxygen)
if 28 - 31 SA : FiO2 30% for a duration 10mn
if <28 SA FIO2 25% for a duration 10mn
SpO2 (arterial oxygen saturation) : to obtain a SpO2 between 88 and 95%
Available IntraVenous line (peripheral, umbilical or central catheter)
Recipient of the French Social Security
Informed consent form signed

Exclusion Criteria

Congenital and/or major malformations
FIO2 >60%
Silverman score >6
Contraindication to the use of Propofol
Low Blood Pressure with 2 successive measurements (Mean < Gestational Age expressed in Weeks of Gestation) persisting after one volume expansion
Use of inotropic medication to maintain a normal blood pressure
Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h
Coma, convulsions, areactivity at neurological examination
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