Premedication Trial for Tracheal Intubation of the NEOnate (PRETTINEO)

Centre Hospitalier Intercommunal Creteil

Status and phase

Completed

Phase 3

Phase 2

Conditions

Premedication

Endotracheal Intubation

Treatments

Drug: atropine+ propofol

Drug: atropine + atracurium + sufentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT01490580

PRETTINEO

Details and patient eligibility

About

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.

Enrollment

173 patients

Sex

All

Ages

Under 28 days old

Volunteers

No Healthy Volunteers

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