Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population
Condition: Obstructive Sleep Apnea of Child
MeSH terms: Sleep Apnea, Obstructive; Inflammation
Study type: Interventional

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.
    

Intervention name(s): Cytokine from blood
Intervention type(s): Diagnostic Test
Intervention description(s): Blood draw- one intraoperative, one 3 weeks postoperative
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention 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)
Primary purpose: Diagnostic