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NCT00659854 Clinical Trial

Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)

Obstructive Sleep Apnea Syndrome Clinical Trial

Official title:
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT00659854
Other study ID # SOR467908CTIL
Secondary ID
Status Not yet recruiting
Phase N/A
First received April 7, 2008
Last updated May 5, 2008
Start date April 2008

Study information
Verified date April 2008
Source Soroka University Medical Center
Contact Aviv D Goldbart, MD
Phone 972-8-624-4465
Email avivgold@bgu.ac.il
Is FDA regulated No
Health authority Israel:clalit Health Services
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 50
Est. completion date
Est. primary completion date April 2010
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 24 Months
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Non milk or soy based formula
Babies will be given a non milk or soy base formula for 12 weeks
• milk based formula
Babies will be given a milk based formula for 12 weeks

Locations
Country Name City State
Israel Soroka University Medical center Beer Sheva

Sponsors (1)
Lead Sponsor Collaborator
Soroka University Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). 24 months No
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