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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:

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.

Condition or disease Intervention/treatment
Obstructive Sleep Apnea Syndrome Dietary Supplement: Non milk or soy based formula Dietary Supplement: milk based formula

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cow's Milk Allergy in Infants With Obstructive Sleep Apnea
Study Start Date : April 2008
Estimated Primary Completion Date : April 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sleep Apnea
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change). [ Time Frame: 24 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
Contacts and Locations

Information from the National Library of Medicine

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, MD 972-8-624-4465 avivgold@bgu.ac.il

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
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
First Posted: April 16, 2008    Key Record Dates
Last Update Posted: May 7, 2008
Last Verified: April 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:
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Milk Hypersensitivity
Pathologic Processes
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Nervous System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases