Cow's Milk Allergy in Infants With Obstructive Sleep Apne... | NCT00659854

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

NCT00659854

Sponsor

Soroka University Medical Center

Status

Unknown status

Last Update Posted

May 7, 2008Estimated

Enrollment

50Estimated

Phase

Not Applicable

Conditions

Obstructive Sleep Apnea Syndrome

Interventions

Non milk or soy based formula
milk based formula

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2010Estimated

Completion Date

Not provided

First Submitted Date

Apr 7, 2008

First Submission Date that Met QC Criteria

Apr 15, 2008

First Posted Date

Apr 16, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 5, 2008

Last Update Posted Date

May 7, 2008Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Non milk or soy based formula	Placebo Comparator	25 infants , non milk or soy based formula .	Dietary Supplement: Non milk or soy based formula
2	Active Comparator	Intervention with milk based formula will be given to 25 infants.	Dietary Supplement: milk based formula

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Non milk or soy based formula	Dietary Supplement	Babies will be given a non milk or soy base formula for 12 weeks	Non milk or soy based formula

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

2 Months

Maximum Age

24 Months

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aviv D Goldbart, MD	Contact	972-8-624-4465		avivgold@bgu.ac.il

Overall Officials

Name	Affiliation	Role
Aviv D Goldbart, MD	Soroka University Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Soroka University Medical center		Beersheba		84101	Israel

Condition Browse Module

MeSH Terms

ID	Term
D020181	Sleep Apnea, Obstructive

Ancestor Terms

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Browse Leaves

Not provided

Browse Branches

Not provided