EUCTR2018-003233-14-FR
Active, not recruiting
Phase 1
Evaluation of the neonatal autonomic stress during intubations under Propofol in a population of premature infants under 33 w’GA - PROPOSURF
CHU de Saint Etienne0 sites30 target enrollmentAugust 23, 2018
Conditionspopulation of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactantMedDRA version: 20.0Level: LLTClassification code 10003969Term: Baby prematureSystem Organ Class: 100000004868MedDRA version: 20.0Level: LLTClassification code 10020477Term: Hyaline membrane diseaseSystem Organ Class: 100000004855MedDRA version: 20.1Level: LLTClassification code 10002321Term: AnesthesiaSystem Organ Class: 100000004852Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- population of premature infants under 33 w’GA requiring intubation for the administration of exogenous surfactant
- Sponsor
- CHU de Saint Etienne
- Enrollment
- 30
- Status
- Active, not recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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