Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
80 participants
INTERVENTIONAL
2016-07-15
2018-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
OTHER
QUADRUPLE
Study Groups
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oxytocin spray
oxytocin nose spray dose 0,4IU/kg, once unique dose
Oxytocin
Single dose oxytocin 45 minutes before the test
placebo
saline nose spray, 0,9 %, once unique dose
placebo
saline solution 0,9% spray nasal
Interventions
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Oxytocin
Single dose oxytocin 45 minutes before the test
placebo
saline solution 0,9% spray nasal
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* age between 3 and 16 years
* stable (3 months with medication maintained or without medication)
Exclusion Criteria
* Use of pituitary hormones, cortisol, androgens and estrogens.
* heart problems: recent AMI, heart failure.
* respiratory problems: pneumonia, respiratory failure, decompensated asthma, acute bronchitis.
3 Years
16 Years
ALL
Yes
Sponsors
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University of Sao Paulo General Hospital
OTHER
Responsible Party
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Helena Paula Brentani
Prof. DRa
Principal Investigators
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Debora Zambori
Role: STUDY_CHAIR
Instituto de Psiquiatria
Locations
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Instituto de Psiquiatria
São Paulo, , Brazil
Countries
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Other Identifiers
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10922213.7.0000.0068-2
Identifier Type: -
Identifier Source: org_study_id
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