NCT00659854

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2008

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

April 7, 2008

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 16, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Last Updated

May 7, 2008

Status Verified

April 1, 2008

Enrollment Period

2 years

First QC Date

April 7, 2008

Last Update Submit

May 5, 2008

Conditions

Obstructive Sleep Apnea Syndrome

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

    24 months

Study Arms (2)

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

Non milk or soy based formulaDIETARY_SUPPLEMENT

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

Non milk or soy based formula
milk based formulaDIETARY_SUPPLEMENT

Babies will be given a milk based formula for 12 weeks

2

Eligibility Criteria

Age2 Months - 24 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Polysomnographically diagnosed OSA
  • Age is 2-24 months
  • Clinical suspicion of milk allergy due to findings in the medical history or physical exam

You may not qualify if:

  • Congenital defects in the pulmonary and gastrointestinal systems
  • Family history of genetic diseases or familial syndromes
  • Infantile asthma.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Soroka University Medical center

Beersheba, 84101, Israel

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea SyndromesApneaRespiration DisordersRespiratory Tract DiseasesSleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System Diseases

Study Officials

  • Aviv D Goldbart, MD

    Soroka University Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aviv D Goldbart, MD

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2008

First Posted

April 16, 2008

Study Start

April 1, 2008

Primary Completion

April 1, 2010

Last Updated

May 7, 2008

Record last verified: 2008-04

Locations

IL(1)