NCT03802708

Brief Summary

Urine sample and exhaled Nitric Oxide will analyzed and compared between children diagnosed with Fetal Alcohol Spectrum Disorder and healthy control. Pilot study- 5 children in each group

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2018

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 23, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.3 years

First QC Date

January 8, 2019

Last Update Submit

March 23, 2020

Conditions

Fetal Alcohol Spectrum Disorder

Outcome Measures

Primary Outcomes (1)

  • Nitric Oxide metabolites in urine

    metabolomic analysis

    At time of enrollment

Secondary Outcomes (1)

  • nitric oxide concentration

    At time of enrollment

Study Arms (1)

control

OTHER

control

Diagnostic Test: Metabolomic analysis urine sample

Interventions

Metabolomic analysis urine sampleDIAGNOSTIC_TEST

a urine sample will be anlayzed for metabolic pathways involving Nitric Oxide Nitric Oxide level will be measured at the exhaled air sample

Also known as: NO- Analyzer breath test
control

Eligibility Criteria

Age5 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children ages 5-16
  • Diagnosis of FASD

You may not qualify if:

  • Sinopulmonary anomaly
  • Cardiac anomaly
  • Asthma
  • Previously known Genetic condition
  • Previously known Metabolic condition
  • Polypharmacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glenrose rehabilitation hospital

Edmonton, Alberta, T5G 0B7, Canada

Location

MeSH Terms

Conditions

Fetal Alcohol Spectrum Disorders

Condition Hierarchy (Ancestors)

Fetal DiseasesPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesAlcohol-Induced DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
this is N/A
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Model Details: pilot. 5 children with FASD- 5 healthy children
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 8, 2019

First Posted

January 14, 2019

Study Start

September 1, 2018

Primary Completion

January 1, 2020

Study Completion

March 23, 2020

Last Updated

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

results from analysis will be available

Locations

CA(1)