Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
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|ClinicalTrials.gov Identifier: NCT00659854|
Recruitment Status : Unknown
Verified April 2008 by Soroka University Medical Center.
Recruitment status was: Not yet recruiting
First Posted : April 16, 2008
Last Update Posted : May 7, 2008
|Condition or disease||Intervention/treatment||Phase|
|Obstructive Sleep Apnea Syndrome||Dietary Supplement: Non milk or soy based formula Dietary Supplement: milk based formula||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Cow's Milk Allergy in Infants With Obstructive Sleep Apnea|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2010|
Placebo Comparator: Non milk or soy based formula
25 infants , non milk or soy based formula .
Dietary Supplement: Non milk or soy based formula
Babies will be given a non milk or soy base formula for 12 weeks
Active Comparator: 2
Intervention with milk based formula will be given to 25 infants.
Dietary Supplement: milk based formula
Babies will be given a milk based formula for 12 weeks
- Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). [ Time Frame: 24 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659854
|Contact: Aviv D Goldbart, MDfirstname.lastname@example.org|
|Soroka University Medical center||Not yet recruiting|
|Beer Sheva, Israel, 84101|
|Contact: Naomi Amichai 972-8-640-3772|
|Principal Investigator:||Aviv D Goldbart, MD||Soroka University Medical Center|