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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT01349205 |
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Date of registration:
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03/05/2011 |
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Primary sponsor: |
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Public title:
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Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study
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Scientific title:
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Caffeine in Children With Obstructive Sleep Apnea, Dose Response Study |
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Date of first enrolment:
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March 2010 |
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Target sample size:
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123 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01349205 |
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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: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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United States
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Contacts
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Name:
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Mohammed Ali, MD |
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Address:
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Telephone:
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713-500-6194 |
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Email:
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Mohammed.ali@uth.tmc.edu |
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Affiliation:
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Name:
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Mohammed Ali, MD |
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Address:
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Telephone:
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7135006194 |
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Email:
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mohammed.ali@uth.tmc.edu |
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Affiliation:
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Name:
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samia Khalil, 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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Memorial Hermann Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Children with OSA and/or increased end tidal C02 (sleep related hypoventilation,
obstructive hypoventilation or sustained alveolar hypoventilation), 2-12 years of
age, and both genders will be eligible to be part of the study. OSA and its severity
will be diagnosed by a preoperative polysomnography.
Exclusion Criteria:
- Children with compromised cardiovascular, pulmonary or renal function, those with
congenital syndromes, sickle cell disease, history of seizures and those receiving
theophylline will be excluded.
Age minimum:
2 Years
Age maximum:
12 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Enlargement of Tonsil or Adenoid
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Obstructive Sleep Apnea
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Intervention(s)
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Drug: 0.9 NS Saline
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Drug: Caffeine and sodium Benzoate 10 mg/kg IV
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Drug: Caffeine and Sodium Benzoate 20 mg/kg IV
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Primary Outcome(s)
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Effects of Caffeine
[Time Frame: Immediately after drug administration upto 24 hours]
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Secondary Outcome(s)
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Caffeine Drug Effects
[Time Frame: Immediately after drug administration to 24 hours]
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Secondary ID(s)
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HSC-MS-09-0457
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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