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Inflammatory Markers in Infants With Obstructive Sleep Apnea

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Soroka University Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Soroka University Medical Center
ClinicalTrials.gov Identifier:
NCT01058590
First received: January 27, 2010
Last updated: NA
Last verified: January 2010
History: No changes posted
  Purpose

Obstructive sleep apnea syndrome (OSAS) is a common disorder in children (2-3%). OSAS in turn, is associated with significant behavioral, learning, and heart problems. Adenotonsillectomy (T&A, meaning the removal of tonsils and adenoids) is the most common treatment for the problem .Diagnosis of OSAS in children is based on overnight polysomnography (sleep study). Recent studies suggest that upper airway and systemic inflammatory changes exists in school-age children and adults with OSAS, and that anti inflammatory therapy can improve respiratory parameters during sleep and reduce adenoid size, similar to surgery. However, there are no data in the literature on inflammatory changes in infants with the disorder.

Healthcare resources utilization, a sensitive marker for diseases is consumed by young children (<3y) with OSAS more then healthy children, from their first year of life We hypothesize that infants and young children with OSAS present local inflammatory changes of the airways as well as systemic inflammation (in the blood or urine) that contribute to the learning, growing and heart associated medical problems. The Aims of the present study are to characterize the local and systemic inflammatory changes of young children with OSAS, and to evaluate their associated medical problems at diagnosis and after therapy (T&A) If indeed inflammation is "responsible" for the development of OSAS at such a young age it should be reduced following therapy (i.e. T&A). In such a case bio-markers may become a part of the algorithms for diagnosis and follow up of such patients.


Condition
Obstructive Sleep Apnea Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Inflammatory Markers in Infants With Obstructive Sleep Apnea

Resource links provided by NLM:


Further study details as provided by Soroka University Medical Center:

Primary Outcome Measures:
  • Analysis of average change in inflammatory markers, before -to-after T%A. [ Time Frame: February 2011 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum and urine will be obtained before therapy (T%A) snd 3 months afterwards. The serum will be stored at -70 throughout the study in the PI's Lab (DR.Goldbart) At the end of the study the sampled will be assessed for the presence of inflammatory markers (cytokines).


Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: February 2012
Estimated Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Detailed Description:

Specific Aims:

  1. To conduct a trial evaluating the effect of Adenonsillectomy in infants (1-36 months of age), with OSA. Outcome measures will include polysomnographic findings conducted prior to and 12 weeks following surgery.
  2. To identify the presence of inflammatory markers (such as, but not only Leukotriene B4, Leukotriene C4/D4/E4, Isoprostane-8, IL-6, TNF-alpha, and other pro inflammatory cytokines) in the peripheral blood (prior and after therapy), and urine (Leukotriene E-4, and others) and correlate their local and systemic expression prior and after therapy to the magnitude of therapy-associated response.

Study Duration: Two years (initial recruitment will be completed within the initial 12 months of the study). Assessment of the samples obtained throughout the study will be done at the latter part of the study.

Setting: Soroka University Hospital . The Sleep Laboratory in Soroka UMC, is the only pediatric one in the city of Beer Sheva and surroundings, evaluates over 1,000 children/year for a variety of sleep disorders, among which >700 are referred for suspected OSAS, among them 100 infants< 2 years/ year.

All children referred for surgery are admitted in the Dept. of Pediatrics where the PI works. We intend to approach all the children prior to surgery and offer them to participate in this study. Those who are interested will gain a sleep study following surgery to validate (or to rull out) the presence of residual OSA and if there is a need, to continue follow up in the pediatric sleep outpatient clinic in Soroka UMC.

  Eligibility

Ages Eligible for Study:   1 Month to 3 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Children aged 0-3 years diagnosed with obstructive sleep apnea syndrome, refferred to removal of tonsills and adenoids

Criteria

Inclusion Criteria:

  • Children aged 1 month-3 years
  • Diagnosis of obstructive sleep apnea syndrome(according to a sleep study)

Exclusion Criteria:

  • Congenital disorders of the respiratory system
  • Congenital craniofacial disorders (retrognathia, Trisomy 21)
  • Use of anti inflammatory medications (like: montelukast, budesonide) up to 4 weeks prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01058590

Contacts
Contact: Aviv D Goldbart, MD 97286244465 avivgold@bgu.ac.il

Locations
Israel
Soroka UMC Not yet recruiting
Beer Sheva, Israel, 84101
Contact: Aviv Goldbart    97286244465      
Sponsors and Collaborators
Soroka University Medical Center
Investigators
Principal Investigator: Aviv D Goldbart, MD Soroka UMC
  More Information

Publications:
Responsible Party: Aviv Goldbart MD, Soroka UMC
ClinicalTrials.gov Identifier: NCT01058590     History of Changes
Other Study ID Numbers: SOR494810ctil
Study First Received: January 27, 2010
Last Updated: January 27, 2010
Health Authority: Israel: The Israel National Institute for Health Policy Research and Health Services Research

Keywords provided by Soroka University Medical Center:
Inflammation
Adenotonsillectomy

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Dyssomnias
Nervous System Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms
Signs and Symptoms, Respiratory
Sleep Disorders
Sleep Disorders, Intrinsic

ClinicalTrials.gov processed this record on November 27, 2014