NCT03134300

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 28, 2017

Completed
1.8 years until next milestone

Study Start

First participant enrolled

January 29, 2019

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

April 26, 2021

Status Verified

April 1, 2021

Enrollment Period

1.9 years

First QC Date

April 19, 2017

Last Update Submit

April 22, 2021

Conditions

Obstructive Sleep Apnea of Child

Outcome Measures

Primary Outcomes (1)

  • Increased cytokines in low SES group

    3 weeks post operative

Study Arms (2)

Low SES

ACTIVE COMPARATOR
Diagnostic Test: Cytokine from blood

Normal/high SES

PLACEBO COMPARATOR
Diagnostic Test: Cytokine from blood

Interventions

Cytokine from bloodDIAGNOSTIC_TEST

Blood draw- one intraoperative, one 3 weeks postoperative

Low SESNormal/high SES

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas Childrens Hospital

Houston, Texas, 77030, United States

Location

Study Officials

  • Arvind Chandrakantan, MD, MBA

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Model Details: 2 groups for the same intervention (AT), one from low SES, one from high SES. Cytokine draw periprocedurally, and 3 weeks post procedure
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology & Pediatrics

Study Record Dates

First Submitted

April 19, 2017

First Posted

April 28, 2017

Study Start

January 29, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

April 26, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)