Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03134300 |
| Other study ID # |
H-39874 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2019 |
| Est. completion date |
December 31, 2020 |
Study information
| Verified date |
April 2021 |
| Source |
Baylor College of Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
