Premedication Trial for Tracheal Intubation of the NEOnate

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

173 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2020-04-15

Brief Summary

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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.

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Detailed Description

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Conditions

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Premedication Endotracheal Intubation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Atropine + Propofol

Group Type EXPERIMENTAL

atropine+ propofol

Intervention Type DRUG

Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg

Atropine + atracurium + sufentanil

Group Type ACTIVE_COMPARATOR

atropine + atracurium + sufentanil

Intervention Type DRUG

Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g

Interventions

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atropine+ propofol

Atropine bolus: 20 µg/kg Propofol injected over 60 seconds: 1 mg/kg for infants \< 1000g - Renewable once 2.5 mg/kg for infants \> 1000G - Possible additional dose of 1 mg/kg

Intervention Type DRUG

atropine + atracurium + sufentanil

Atropine bolus: 20 µg/kg Atracurium: 0.3 mg/kg- Possible additional dose of 0.1 mg/kg Sufentanil: 0.1 µg/kg for infants \< 1000g 0.2 µg/kg for infants \> 1000g

Intervention Type DRUG

Eligibility Criteria

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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

Maximum Eligible Age

28 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

No