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

Not Applicable

• Conditions: Obstructive Sleep Apnea Syndrome
• Interventions: Dietary Supplement: milk based formula; Dietary Supplement: Non milk or soy based formula

• Registration Number: NCT00659854
• Lead Sponsor: Soroka University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-04
• Study Start: 2008-04
• Study First Submitted: 2008-04-07
• Study First Submitted QC: 2008-04-15
• Study First Posted: 2008-04-16
• Last Update Submitted: 2008-05-05
• Last Update Posted: 2008-05-07
• Primary Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	milk based formula	Intervention with milk based formula will be given to 25 infants.
Non milk or soy based formula	Non milk or soy based formula	25 infants , non milk or soy based formula .

Primary Outcome Measures

Name	Time	Method
Polysomnographic variables following 12 weeks of non-milk based formula, in comparison to baseline(prior to diet change).	24 months

Trial Locations

Locations (1)

Soroka University Medical center; 🇮🇱 Beer Sheva, Israel