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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
Sponsor:
Information provided by:
Soroka University Medical Center

April 7, 2008
April 16, 2008
May 7, 2008
April 2008
April 2010   (Final data collection date for primary outcome measure)
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). [ Time Frame: 24 months ]
Same as current
Complete list of historical versions of study NCT00659854 on ClinicalTrials.gov Archive Site
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Not Provided
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Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
Cow's milk allergy may be involved in the evolution of sleep apnea in infants. The study will assess the effects of specifies diet changes (i.e. non-milk based formula) on the infant. Specifically , infants will be investigated by sleep studies in order to test this hypothesis.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Obstructive Sleep Apnea Syndrome
  • Dietary Supplement: Non milk or soy based formula
    Babies will be given a non milk or soy base formula for 12 weeks
  • Dietary Supplement: milk based formula
    Babies will be given a milk based formula for 12 weeks
  • Placebo Comparator: Non milk or soy based formula
    25 infants , non milk or soy based formula .
    Intervention: Dietary Supplement: Non milk or soy based formula
  • Active Comparator: 2
    Intervention with milk based formula will be given to 25 infants.
    Intervention: Dietary Supplement: milk based formula
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
50
Same as current
Not Provided
April 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Polysomnographically diagnosed OSA
  2. Age is 2-24 months
  3. Clinical suspicion of milk allergy due to findings in the medical history or physical exam

Exclusion Criteria:

  1. Congenital defects in the pulmonary and gastrointestinal systems
  2. Family history of genetic diseases or familial syndromes
  3. Infantile asthma.
Sexes Eligible for Study: All
2 Months to 24 Months   (Child)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT00659854
SOR467908CTIL
Yes
Not Provided
Not Provided
Aviv D Goldbart MD, Soroka University Medical Center
Soroka University Medical Center
Not Provided
Principal Investigator: Aviv D Goldbart, MD Soroka University Medical Center
Soroka University Medical Center
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP