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

Soroka University Medical Center

Status: Unknown

Conditions: Obstructive Sleep Apnea Syndrome

Treatments: Dietary Supplement: Non milk or soy based formula; Dietary Supplement: milk based formula

Study type: Interventional

Funder types: Other

Identifiers

NCT00659854

SOR467908CTIL

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 2 to 24 months old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups, including a placebo group

Non milk or soy based formula

Placebo Comparator group

Description:

25 infants , non milk or soy based formula .

Treatment:

Dietary Supplement: Non milk or soy based formula

2

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: milk based formula