NCT04186949

Brief Summary

Birth cohort study with recruitment during pregnancy to determine prenatal and perinatal conditions, as well as genetic and epigenetic factors, that participate in the early setting of immune responses, and the role of these in the later determination of the risk of allergic diseases, asthma, and metabolic conditions in the offspring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
273

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

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

October 9, 2018

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 3, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 5, 2019

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

February 7, 2024

Status Verified

March 1, 2023

Enrollment Period

4.2 years

First QC Date

December 3, 2019

Last Update Submit

February 5, 2024

Conditions

AllergyAsthmaFood AllergyAllergic SensitisationAtopic Dermatitis

Keywords

birth cohortChile

Outcome Measures

Primary Outcomes (1)

  • Development of allergic diseases in offspring

    Atopic dermatitis, food allergy, allergic sensitization, predicted increased risk of asthma

    2 years

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women living in Chile's central regions (i.e. mothers), their partners (i.e. fathers), and their offspring.

You may qualify if:

  • Pregnant women living in Chile's central regions
  • Offspring of women recruited in the cohort study

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pontificia Universidad Católica de Chile

Santiago, RM, 8330077, Chile

Location

Related Publications (1)

  • Hernandez CD, Casanello P, Harris PR, Castro-Rodriguez JA, Iturriaga C, Perez-Mateluna G, Farias M, Urzua M, Hernandez C, Serrano C, Sandoval M, Hoyos-Bachiloglu R, Uauy R, Borzutzky A. Early origins of allergy and asthma (ARIES): study protocol for a prospective prenatal birth cohort in Chile. BMC Pediatr. 2020 Apr 15;20(1):164. doi: 10.1186/s12887-020-02077-x.

    PMID: 32293348BACKGROUND

MeSH Terms

Conditions

HypersensitivityAsthmaFood HypersensitivityDermatitis, Atopic

Condition Hierarchy (Ancestors)

Immune System DiseasesBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateSkin Diseases, GeneticGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDermatitisSkin DiseasesSkin and Connective Tissue DiseasesSkin Diseases, Eczematous

Study Officials

  • Arturo Borzutzky, M.D.

    Pontificia Universidad Catolica de Chile

    STUDY DIRECTOR

  • Paul Harris, M.D.

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • Paola Casanello, PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

  • José A Castro-Rodriguez, M.D. PhD

    Pontificia Universidad Catolica de Chile

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2019

First Posted

December 5, 2019

Study Start

October 9, 2018

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

February 7, 2024

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CL(1)