Cytokine Persistence as a Marker of Inflammation in the at Risk, Low Socioeconomic Status Pediatric Population

NCT ID: NCT03134300

Last Updated: 2021-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-29
• Study Completion Date: 2020-12-31

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.

Conditions

Obstructive Sleep Apnea of Child

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Low SES

Group Type: ACTIVE_COMPARATOR

Cytokine from blood

Intervention Type: DIAGNOSTIC_TEST

Blood draw- one intraoperative, one 3 weeks postoperative

Normal/high SES

Group Type: PLACEBO_COMPARATOR

Cytokine from blood

Intervention Type: DIAGNOSTIC_TEST

Blood draw- one intraoperative, one 3 weeks postoperative

Interventions

Cytokine from blood

Blood draw- one intraoperative, one 3 weeks postoperative

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Exclusion Criteria

-

• Minimum Eligible Age: 5 Years
• Maximum Eligible Age: 10 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Arvind Chandrakantan

Assistant Professor of Anesthesiology & Pediatrics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Arvind Chandrakantan, MD, MBA

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas Childrens Hospital

Houston, Texas, United States

Countries

United States

Other Identifiers

H-39874

Identifier Type: -

Identifier Source: org_study_id