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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
Information provided by:
Soroka University Medical Center Identifier:
First received: April 7, 2008
Last updated: May 5, 2008
Last verified: April 2008
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


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. 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 identifier: NCT00659854

Contact: Aviv D Goldbart, MD 972-8-624-4465

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 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:
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 processed this record on May 25, 2017