Evaluation of the neonatal autonomic stress during intubations under Propofol in a population of premature infants under 33 w’GA

Phase 1

• Conditions: population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant; MedDRA version: 20.0Level: LLTClassification code 10003969Term: Baby prematureSystem Organ Class: 100000004868; MedDRA version: 20.0Level: LLTClassification code 10020477Term: Hyaline membrane diseaseSystem Organ Class: 100000004855; MedDRA version: 20.1Level: LLTClassification code 10002321Term: AnesthesiaSystem Organ Class: 100000004852; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2018-003233-14-FR
• Lead Sponsor: CHU de Saint Etienne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-23
• Last Update Posted: 12 March 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

•Preterm neonates (< 33 weeks GA) requiring in the first week of life, an elective tracheal intubation for surfactant administration by INSURE or LISA methods.
•Collected Consent from parents

Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

•Preterm neonates with Intraventricular hemorrhage grade III & IV
•Preterm neonates with hemodynamic instability
•Preterm neonates with congenital heart disease
•Preterm neonates with severe congenital malformation
•Preterm neonates already sedated and/or under invasive mechanical ventilation

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified