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

NCT ID: NCT00659854

Last Updated: 2008-05-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Obstructive Sleep Apnea Syndrome

Keywords

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obstructive sleep apnea syndrome The study examines the response of infants diagnosed with obstructive sleep apnea syndrome to diet changes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Non milk or soy based formula

25 infants , non milk or soy based formula .

Group Type PLACEBO_COMPARATOR

Non milk or soy based formula

Intervention Type DIETARY_SUPPLEMENT

Babies will be given a non milk or soy base formula for 12 weeks

2

Intervention with milk based formula will be given to 25 infants.

Group Type ACTIVE_COMPARATOR

milk based formula

Intervention Type DIETARY_SUPPLEMENT

Babies will be given a milk based formula for 12 weeks

Interventions

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Non milk or soy based formula

Babies will be given a non milk or soy base formula for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

milk based formula

Babies will be given a milk based formula for 12 weeks

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

2 Months

Maximum Eligible Age

24 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Soroka University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Soroka University Medical Center

Principal Investigators

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Aviv D Goldbart, MD

Role: PRINCIPAL_INVESTIGATOR

Soroka University Medical Center

Locations

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Soroka University Medical center

Beersheba, , Israel

Site Status

Countries

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Israel

Central Contacts

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Aviv D Goldbart, MD

Role: CONTACT

Phone: 972-8-624-4465

Email: [email protected]

Facility Contacts

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Naomi Amichai

Role: primary

Other Identifiers

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SOR467908CTIL

Identifier Type: -

Identifier Source: org_study_id