Premedication Trial for Tracheal Intubation of the NEOnate

• Status: Completed
• Trial end date: 2020-04-15
• Target enrollment: 0
• Participant gender: All

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 outcome: pulse oxymetry value < 80% for more than 60 seconds. Secondary outcomes:

number of attempts, duration of the procedure, changes in physiologic parameters, short- and long-term neurodevelopmental outcome.

Hypothesis: "atropine + propofol" compared to "atropine+atracurium+sufentanil" will significantly reduce the frequency of severe hypoxemia.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centre Hospitalier Intercommunal Creteil
• Collaborators: ACTIV (Association Clinique et Thérapeutique du Val de Marne); Association Clinique Thérapeutique Infantile du val de Marne; CRC (Centre de Recherche Clinique) du CHIC
• Treatments: Atracurium; Atropine; Propofol; Sufentanil

Criteria

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