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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01075490 |
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Date of registration:
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12/05/2009 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine
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Scientific title:
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Neonatal Spinal Anesthesia: Effects of the Addition of Clonidine |
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Date of first enrolment:
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November 2006 |
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Target sample size:
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120 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01075490 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Xavier Capdevila, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Montpellier, France |
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Name:
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Alain Rochette, MD |
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Address:
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Telephone:
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(33)467338256 |
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Email:
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a-rochette@chu-montpellier.fr |
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Affiliation:
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Name:
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Alain Rochette, MD |
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Address:
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Telephone:
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(33)467338256 |
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Email:
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a-rochette@chu-montpellier.fr |
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Affiliation:
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Name:
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Alain Rochette, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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CHU de Montpellier, France |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Newborns less than 60 weeks old post-conceptional, former premature or not
- Newborns requiring inguinal hernia or lower limbs surgery,
- infants needing no more critical care assistance
- Informed consent of parents
Exclusion Criteria:
- Spinal malformation,
- Coagulopathy,
- critical hemodynamics,
- uncontrolled neurologic or metabolic pathology.
- infection at injection point.
Age minimum:
N/A
Age maximum:
60 Weeks
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Neonates
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Spinal Anesthesia
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Intervention(s)
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Drug: clonidine
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Primary Outcome(s)
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number of "rescue" general anesthesia
[Time Frame: end of surgery]
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Secondary Outcome(s)
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apnea and desaturation occurrence
[Time Frame: during 24h]
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duration of spinal anesthesia
[Time Frame: during 24h]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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