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

Soroka University Medical Center50 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Non milk or soy based formulaDIETARY_SUPPLEMENT

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

milk based formulaDIETARY_SUPPLEMENT

Babies will be given a milk based formula for 12 weeks

Eligibility

Sex: ALLMin age: 2 MonthsMax age: 24 Months

Medical Language ↔ Plain English

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.

Locations (1)

Soroka University Medical center

Beersheba, Israel

Outcomes

Primary Outcomes

Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).

Time frame: 24 months

Central Contacts

Aviv D Goldbart, MD

CONTACT

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

Data from ClinicalTrials.gov

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