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Cow's Milk Allergy in Infants With Obstructive Sleep Apnea (OSA)
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2008 by Soroka University Medical Center.
Recruitment status was: Not yet recruiting
Recruitment status was: Not yet recruiting
Sponsor:
Soroka University Medical Center
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT00659854
First received: April 7, 2008
Last updated: May 5, 2008
Last verified: April 2008
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Purpose
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.
| Condition | Intervention |
|---|---|
| Obstructive Sleep Apnea Syndrome | Dietary Supplement: Non milk or soy based formula Dietary Supplement: milk based formula |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Cow's Milk Allergy in Infants With Obstructive Sleep Apnea |
Resource links provided by NLM:
Further study details as provided by Soroka University Medical Center:
Primary Outcome Measures:
- Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). [ Time Frame: 24 months ]
| Estimated Enrollment: | 50 |
| Study Start Date: | April 2008 |
| Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 2 Months to 24 Months (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659854
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659854
Contacts
| Contact: Aviv D Goldbart, MD | 972-8-624-4465 | avivgold@bgu.ac.il |
Locations
| Israel | |
| Soroka University Medical center | Not yet recruiting |
| Beer Sheva, Israel, 84101 | |
| Contact: Naomi Amichai 972-8-640-3772 | |
Sponsors and Collaborators
Soroka University Medical Center
Investigators
| Principal Investigator: | Aviv D Goldbart, MD | Soroka University Medical Center |
More Information
| Responsible Party: | Aviv D Goldbart MD, Soroka University Medical Center |
| ClinicalTrials.gov Identifier: | NCT00659854 History of Changes |
| Other Study ID Numbers: |
SOR467908CTIL |
| Study First Received: | April 7, 2008 |
| Last Updated: | May 5, 2008 |
Keywords provided by Soroka University Medical Center:
|
obstructive sleep apnea syndrome The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes |
Additional relevant MeSH terms:
|
Syndrome Apnea Sleep Apnea Syndromes Sleep Apnea, Obstructive Milk Hypersensitivity Disease Pathologic Processes Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory |
Signs and Symptoms Sleep Disorders, Intrinsic Dyssomnias Sleep Wake Disorders Nervous System Diseases Food Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
ClinicalTrials.gov processed this record on July 21, 2017