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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
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
  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 ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
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

No publications provided

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
Health Authority: Israel:clalit Health Services

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:
Milk Hypersensitivity
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases
Food Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 21, 2014