NCT01006668

Brief Summary

Endotracheal intubation is a painful and stressful procedure, which is associated with acute increases of blood pressure, intracranial pressure, bradycardia and hypoxemia with high morbidity. The aim of the study is to compare recovery time, efficacy and tolerance in a randomized controlled study, between sevoflurane and propofol for intubation in neonates in Neonatal Intensive Care Unit.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at below P25 for phase_3

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 19, 2009

Completed
13 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 3, 2009

Completed
5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

5 years

First QC Date

October 19, 2009

Last Update Submit

August 28, 2014

Conditions

Endotracheal Intubation

Keywords

NeonatesIntensive careEndotracheal intubationNeonates in intensive care

Outcome Measures

Primary Outcomes (1)

  • To compare recovery time between sevoflurane and propofol for intubation of neonates.

    18 months

Secondary Outcomes (1)

  • To compare efficacy and tolerance between sevoflurane and propofol for intubation of neonates.

    18 months

Study Arms (2)

Sevoflurane

EXPERIMENTAL

Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.

Drug: Administration of sevoflurane

Propofol

ACTIVE COMPARATOR

Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary

Drug: Administration of propofol

Interventions

Administration of sevofluraneDRUG

Administration of sevoflurane (SEVORANE) by inhalation until a maximal concentration of 4% of inspired gas.

Sevoflurane
Administration of propofolDRUG

Administration of propofol (DIPRIVAN) by intravenous injection (1 mg/kg to turn over twice if necessary.

Propofol

Eligibility Criteria

AgeUp to 28 Days
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Neonates
  • Hospitalized in neonatal intensive care unit
  • Needing of an endotracheal intubation

You may not qualify if:

  • Emergency state
  • Predictable difficult endotracheal intubation
  • Decrease of blood pressure
  • Neurological disorders
  • Morphinic treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique - Hôpitaux de Marseille

Marseille, France

RECRUITING

Study Officials

  • Fabrice MICHEL

    Assistance Publique - Hôpitaux de Marseille

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabrice MICHEL

CONTACT

fabrice.michel@ap-hm.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 19, 2009

First Posted

November 3, 2009

Study Start

November 1, 2009

Primary Completion

November 1, 2014

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

FR(1)