No intervention in Chronic Diseases in Children - Clinical Trials Registry

Study Overview

Status

Active, not recruiting

Conditions

Chronic Diseases in Children

Intervention / Treatment

Other: No intervention

Detailed Description

Role of the exposome and epigenetics on allergy, caries, and neurophysiological development in childhood as studied in a birth cohort of 650 trioses. The exposome includes repeated measures of nutrition, micronutritients, microbiota, toxic agents and the clinical outcomes, diagnoses of allergy, caries and neurophysiological functions/dysfunctions.

Study Type

Observational

Enrollment (Actual)

1950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Sweden
- Norrbotten County
  - Luleå, Norrbotten County, Sweden, 97180
    - Sunderby Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

650 families (mother/father/child).

Description

Inclusion Criteria:

Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018

Exclusion Criteria:

Parents not able to speak or write Swedish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with excema Time Frame: Outcome at one year	Excema	Outcome at one year
Number of participants with food allergy Time Frame: Outcome at one year	Food allergy	Outcome at one year
Number of participants with frhino-conjuctivitis Time Frame: Outcome at one year	Rhino-conjunctivitis	Outcome at one year
Number of participants with asthma Time Frame: Outcome at one year	Asthma	Outcome at one year
Number of participants with excema Time Frame: Outcome at four years	Excema	Outcome at four years
Number of participants with food allergy Time Frame: Outcome at four years	Food allergy	Outcome at four years
Number of participants with rhino-conjunctivitis Time Frame: Outcome at four years	Rhino-conjuctivitis	Outcome at four years
Number of participants with asthma Time Frame: Outcome at four years	Asthma	Outcome at four years
Number of participants with excema Time Frame: Outcome at six years	Excema	Outcome at six years
Number of participants with food allergy Time Frame: Outcome at six years	Food allergy	Outcome at six years
Number of participants with rhino-conjunctivitis Time Frame: Outcome at six years	Rhino-conjunctivitis	Outcome at six years
Number of participants with asthma Time Frame: Outcome at six years	Asthma	Outcome at six years
Numbers of caries lesions (DeMFS = decayed, enamel included, missed, filled, tooth surfaces, in each child Time Frame: Outcome at four years	Cariesfree individuals have a DeMFS = 0 and increasing scores means increasing degree of caries. Maximum DeMFS = 148, minumum DeMFS = 0.	Outcome at four years
Child cognition as measured by Wechsler Preschool and Primary Scale of Intelligence Time Frame: Outcome at four years	Cognitive development will be tested face-to-face with Wechsler Preschool and Primary Scale of Intelligence. Increasing scores means increasing intelligence.	Outcome at four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Collaborators

Karolinska Institutet

The Swedish Research Council

Göteborg University

Chalmers University of Technology

Forte

The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)

Region Norrbotten

Investigators

Principal Investigator: Anna Sandin, Ass Prof, Umeå University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2015

Primary Completion (Anticipated)

June 1, 2024

Study Completion (Anticipated)

June 1, 2030

Study Registration Dates

First Submitted

March 14, 2023

First Submitted That Met QC Criteria

March 28, 2023

First Posted (Actual)

April 12, 2023

Study Record Updates

Last Update Posted (Actual)