NICE - Nutritional Impact on Immunological Maturation During Childhood in Relation to the Environment
NICE
1 other identifier
observational
1,950
1 country
1
Brief Summary
Role of the exposome on allergy, caries, and neurophysiological development in childhood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2015
Longer than P75 for all trials
1 active site
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
Study Start
First participant enrolled
June 1, 2015
CompletedFirst Submitted
Initial submission to the registry
March 14, 2023
CompletedFirst Posted
Study publicly available on registry
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2030
ExpectedApril 12, 2023
March 1, 2023
9 years
March 14, 2023
March 28, 2023
Conditions
Outcome Measures
Primary Outcomes (14)
Number of participants with excema
Excema
Outcome at one year
Number of participants with food allergy
Food allergy
Outcome at one year
Number of participants with frhino-conjuctivitis
Rhino-conjunctivitis
Outcome at one year
Number of participants with asthma
Asthma
Outcome at one year
Number of participants with excema
Excema
Outcome at four years
Number of participants with food allergy
Food allergy
Outcome at four years
Number of participants with rhino-conjunctivitis
Rhino-conjuctivitis
Outcome at four years
Number of participants with asthma
Asthma
Outcome at four years
Number of participants with excema
Excema
Outcome at six years
Number of participants with food allergy
Food allergy
Outcome at six years
Number of participants with rhino-conjunctivitis
Rhino-conjunctivitis
Outcome at six years
Number of participants with asthma
Asthma
Outcome at six years
Numbers of caries lesions (DeMFS = decayed, enamel included, missed, filled, tooth surfaces, in each child
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
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
Interventions
No intervention
Eligibility Criteria
650 families (mother/father/child).
You may qualify if:
- Born at Sunderby hospital, Region Norrbotten, during time period 2015-2018
You may not qualify if:
- Parents not able to speak or write Swedish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Umeå Universitylead
- Göteborg Universitycollaborator
- Chalmers University of Technologycollaborator
- Karolinska Institutetcollaborator
- Region Norrbottencollaborator
- The Swedish Research Councilcollaborator
- Fortecollaborator
- The Swedish Research Council for Environment, Agricultural Sciences and Spatial Planning (FORMAS)collaborator
Study Sites (1)
Sunderby Hospital
Luleå, Norrbotten County, 97180, Sweden
Biospecimen
Saliva, faeces, blood, placenta, hair, breast milk.
Study Officials
- PRINCIPAL INVESTIGATOR
Anna Sandin, Ass Prof
Umeå University
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2023
First Posted
April 12, 2023
Study Start
June 1, 2015
Primary Completion
June 1, 2024
Study Completion (Estimated)
June 1, 2030
Last Updated
April 12, 2023
Record last verified: 2023-03
Data Sharing
- IPD Sharing
- Will not share