Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Primary Purpose
Obstructive Sleep Apnea Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Non milk or soy based formula
milk based formula
Sponsored by
About this trial
This is an interventional treatment trial for Obstructive Sleep Apnea Syndrome focused on measuring obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
Eligibility Criteria
Inclusion Criteria:
- Polysomnographically diagnosed OSA
- Age is 2-24 months
- Clinical suspicion of milk allergy due to findings in the medical history or physical exam
Exclusion Criteria:
- Congenital defects in the pulmonary and gastrointestinal systems
- Family history of genetic diseases or familial syndromes
- Infantile asthma.
Sites / Locations
- Soroka University Medical center
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Non milk or soy based formula
2
Arm Description
25 infants , non milk or soy based formula .
Intervention with milk based formula will be given to 25 infants.
Outcomes
Primary Outcome Measures
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
Secondary Outcome Measures
Full Information
NCT ID
NCT00659854
First Posted
April 7, 2008
Last Updated
May 5, 2008
Sponsor
Soroka University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT00659854
Brief Title
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
Official Title
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
April 2010 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Soroka University Medical Center
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea Syndrome
Keywords
obstructive sleep apnea syndrome, The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non milk or soy based formula
Arm Type
Placebo Comparator
Arm Description
25 infants , non milk or soy based formula .
Arm Title
2
Arm Type
Active Comparator
Arm Description
Intervention with milk based formula will be given to 25 infants.
Intervention Type
Dietary Supplement
Intervention Name(s)
Non milk or soy based formula
Intervention Description
Babies will be given a non milk or soy base formula for 12 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
milk based formula
Intervention Description
Babies will be given a milk based formula for 12 weeks
Primary Outcome Measure Information:
Title
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
24 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Polysomnographically diagnosed OSA
Age is 2-24 months
Clinical suspicion of milk allergy due to findings in the medical history or physical exam
Exclusion Criteria:
Congenital defects in the pulmonary and gastrointestinal systems
Family history of genetic diseases or familial syndromes
Infantile asthma.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aviv D Goldbart, MD
Phone
972-8-624-4465
Email
avivgold@bgu.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aviv D Goldbart, MD
Organizational Affiliation
Soroka University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Soroka University Medical center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naomi Amichai
Phone
972-8-640-3772
12. IPD Sharing Statement
Learn more about this trial
Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
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