Status:
COMPLETED
Premedication Trial for Tracheal Intubation of the NEOnate
Lead Sponsor:
Centre Hospitalier Intercommunal Creteil
Collaborating Sponsors:
Association Clinique Thérapeutique Infantile du val de Marne
Conditions:
Premedication
Endotracheal Intubation
Eligibility:
All Genders
Up to 28 years
Phase:
PHASE2
PHASE3
Brief Summary
Multicenter double blind randomized controlled trial comparing "atropine+propofol" vs "atropine+atracurium+sufentanil" as a premedication prior to endotracheal intubation of the neonate. Primary outc...
Eligibility Criteria
Inclusion
- Corrected age \< 45 weeks of gestational age
- Currently hospitalized in a neonatal intensive care unit
- Requiring semi-urgent or elective intubation
- Equipped with a reliable and permeable IV line
- Parental consent
Exclusion
- Lack of parental consent
- Parental refusal
- Sedative or anesthetic treatment in the previous 24 hours
- Hemodynamic compromise defined as mean blood pressure\< corrected GA and/or refill time \> 3 seconds
- Upper airway malformation
- Life-threatening situation requiring immediate intubation
- Inclusion in another trial not permitting any other participation
- Impossibility to establish venous access
- Any contra-indication to any experimental drug
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 15 2020
Estimated Enrollment :
173 Patients enrolled
Trial Details
Trial ID
NCT01490580
Start Date
May 1 2012
End Date
April 15 2020
Last Update
March 4 2021
Active Locations (6)
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1
Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord
Amiens, France, 80054
2
Hôpital Mère-Enfant
Bron, France, 69677
3
CHU de Caen
Caen, France
4
Centre Hospitalier Intercommunal de Créteil
Créteil, France, 94000