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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
Soroka University Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

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

2 Months - 24 Months (Child)All SexesDoes not accept healthy volunteers

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.

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

First Posted
April 7, 2008
Last Updated
May 5, 2008
Sponsor
Soroka University Medical Center
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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

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

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