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COMPLETEDPhase 2/3NCT01490580

Premedication Trial for Tracheal Intubation of the NEOnate

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...

Lead sponsor: Centre Hospitalier Intercommunal Creteil•6 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Centre Hospitalier Intercommunal Creteil

Collaborators

Association Clinique Thérapeutique Infantile du val de Marne

Age

0 - 0 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•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 Criteria

•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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: March 4, 2021Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE2/PHASE3

Enrollment173

Start dateMay 2012

Last updatedMar 4, 2021

Condition

Premedication Endotracheal Intubation

Locations shown

Médecine Néonatale et Réanimation Pédiatrique Polyvalente, CHU Amiens Nord

Amiens

Hôpital Mère-Enfant

Bron

CHU de Caen

Caen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2021Data synced to Clareo: July 13, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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