Respiratory effect of the LISA (Less Invasive surfactant administration) method with sedation by propofol versus absence of sedation: Double-blind comparative randomized clinical trial

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Centre Hospitalier Universitaire Grenoble Alpes

Participant type

Pediatric, Patients

Age range

0-17 years

Gender

Male and Female

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

Trial duration

7 Oct 2019 → ongoing

Decision date (initial)

2024-12-02

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

Funding sources

DGOS (French Health Ministry) and Centre Hospitalier Universitaire Grenoble Alpes

External identifiers

EU CT number

2024-518836-36-00

EudraCT number

2018-002876-41

ClinicalTrials.gov

NCT04016246

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety

In a population of preterm babies less than<32 wGA, our objective is to perform a double-blind, non-inferiority trial comparing sedation by propofol versus placebo during the LISA procedure, evaluating the need for MV within 72 hours of life.

Secondary objectives 7

1. To compare sedation by Propofol versus placebo during the LISA procedure, evaluating the need for MV within 72hours of life, in each class of GA (<28, 28-31wGA)
2. To assess comfort and reduction of pain in the intervention versus control group, during the LISA procedure and at 1 hour after it
3. To assess the rate of ketamine administration for rescue in each group
4. To assess the quality conditions of the procedure: per procedure events (tolerance) and the clinician’s satisfaction (efficacy) during the LISA procedure
5. To assess BPD at 36wGA
6. To assess in-hospital neonatal morbidity and mortality
7. To evaluate the neurodevelopmental outcome at two years corrected age among survivors.

Conditions and MedDRA coding

Respiratory Distress Syndrome of preterm babies born < 32 weeks of gestational age

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 5

1. Preterm Infants < 32 wGA
2. Presenting a RDS  in the first 48 hours of life  treated by CPAP or BiPAP  requiring surfactant :  FIO2 : - if 28 - 31 SA : FiO2 ≥30% for a duration ≥ 10mn - if <28 SA FIO2 ≥25% for a duration ≥10mn  SpO2 : To obtain a SpO2 between ≥88 and ≤ 95%
3. Available Intra-Venous line (peripheral, umbilical or central catheter)
4. Covered by French Social Security
5. Informed consent form signed

Exclusion criteria 6

1. Congenital and/or major malformations
2. FIO2> 60% at the time of the inclusion
3. Silverman score > 6
4. 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 normal blood pressure.
5. Use of sedative or analgesic drugs (except paracetamol and ibuprofen) in the previous 24h
6. Coma, convulsions, areactivity at neurological examination

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Rate of MV from the start of the LISA procedure up to 72 hours of life in each group.

Secondary endpoints 7

1. Rate of MV from the start of the LISA procedure up to 72 hours of life in each class of GA (<28, 28-31wGA)
2. Faceless Acute Neonatal Scale (FANS) assessed during the LISA: this scale evaluates behavioral items (limb movements, vocal expression) and physiological items (heart rate variation, bradycardia or desaturation), on a scale from 0 (no pain) to 10 (maximal pain).
3. Rate of ketamine administration for rescue: This administration will be indicated after two (< 28 wGA) or 3 (28 – 31 wGA) administrations of the drug, if adequate comfort is not achieved (FANS≥6 or baby not comfortable)
4. Quality conditions
5. To assess BPD at 36wGA
6. In-hospital neonatal morbidity and mortality
7. At two years : ASQ questionnaire, Gross Motor Function Classification Scale in cases of motor impairment, Visual and hearing function

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Centre Hospitalier Universitaire Grenoble Alpes

Sponsor organisation

Centre Hospitalier Universitaire Grenoble Alpes

Address

Boulevard De La Chantourne, Cs 10217, La Tronche Cs 10217 La Tronche

City

Grenoble Cedex 9

Postcode

38043

Country

France

Scientific contact point

Organisation

Centre Hospitalier Universitaire Grenoble Alpes

Contact name

DEBILLON Thierry

Public contact point

Organisation

Centre Hospitalier Universitaire Grenoble Alpes

Contact name

DEBILLON Thierry

Locations

1 EU/EEA country · 15 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Application history

3 submissions — initial application plus substantial / non-substantial modifications