Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population
Primary Purpose
Obstructive Sleep Apnea of Child
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cytokine from blood
Sponsored by
About this trial
This is an interventional diagnostic trial for Obstructive Sleep Apnea of Child
Eligibility Criteria
Inclusion Criteria: OSA for adenotonsillectomy -
Exclusion Criteria:
-
Sites / Locations
- Texas Childrens Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Low SES
Normal/high SES
Arm Description
Outcomes
Primary Outcome Measures
Increased cytokines in low SES group
Secondary Outcome Measures
Full Information
NCT ID
NCT03134300
First Posted
April 19, 2017
Last Updated
April 22, 2021
Sponsor
Baylor College of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03134300
Brief Title
Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population
Official Title
Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 29, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The investigators wish to study the role of persistent markers of inflammation in executive function in young children during critical periods of synaptogenesis (ages 2-3). While the role of markers of inflammation have been validated in the pathogenesis in multiple disorders in the adult population, their study in pediatrics is limited. The investigators therefore propose that demonstration of persistent cytokine inflammatory markers in this preliminary study will allow larger studies to proceed.
Detailed Description
Obstructive sleep apnea (OSA) is a common multisystem disorder, affecting up to 10% of the pediatric population. There is scant data about OSA and adenotonsillectomy (AT) outcomes in the very young (ages 1-3). Young children with moderate/severe OSA are often underprivileged, low socioeconomic status (SES) minorities with limited access to care. Further complicating the problem is that African American children may suffer a higher preoperative and post-AT burden of disease, with greater negative consequences to these vulnerable children. Up to 75% of children with OSA continue to have sequelae of the disease post-AT. These include poor school performance, delayed speech, inattention, and long term neurocognitive dysfunction. It has been demonstrated that younger patients (below the age of 3) have larger tonsils and stunted growth on presentation for AT. More telling is that younger children face greater morbidity from the procedure, including respiratory complications, postoperative bleeding, and perioperative anoxic/hypoxic injury as validated by multiple studies. A recent study studied watchful waiting versus early AT in two groups of patients aged 5-9 without severe OSA. The findings indicated that early AT improved respiratory and quality of life indices without corresponding improvement in attention or cognitive function as assessed by neuropsychological testing 7 months post intervention. So it leads to the further question of whether children with severe OSA truly benefit from the procedure at all, and whether there maybe a trend towards harm. In this particular scenario, the investigators are hypothesizing that serum based biomarkers in the form of cytokines are of significant diagnostic benefit in demonstrating ongoing inflammation.
Therefore, the surgical stimulus and consequent stress response in the form of centrally mediated cytokines and inflammatory mediators demands study. These has been well analyzed with adult acute and chronic pain, and have been associated with neurocognitive impairment, but have not been studied as a neurocognitive biomarker in the pediatric population. Children from lower SES, with less stable social environments, or other cultural/linguistic barriers are higher risk and urgently require study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea of Child
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2 groups for the same intervention (AT), one from low SES, one from high SES. Cytokine draw periprocedurally, and 3 weeks post procedure
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low SES
Arm Type
Active Comparator
Arm Title
Normal/high SES
Arm Type
Placebo Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Cytokine from blood
Intervention Description
Blood draw- one intraoperative, one 3 weeks postoperative
Primary Outcome Measure Information:
Title
Increased cytokines in low SES group
Time Frame
3 weeks post operative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: OSA for adenotonsillectomy -
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Arvind Chandrakantan, MD, MBA
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas Childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population
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