ZIKAlliance Children Cohort (ZIKAllianceCH)
ZIKAllianceCH
Children (CH) Cohort for the Evaluation of Developmental and Neurological Abnormalities in Infants Born to Mothers Residing in Areas With Zika Virus Transmission During Pregnancy
1 other identifier
observational
1,554
7 countries
10
Brief Summary
The aim of this proposal is to evaluate the causal relationship between Zika virus (ZIKV) infections in pregnancy and congenital malformations. The study will estimate the absolute and relative risks of congenital malformations and other adverse outcomes of pregnancy among women who become infected with ZIKV during pregnancy compared to uninfected pregnant women, also leading to further validation of the Congenital Zika Syndrome.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2018
Longer than P75 for all trials
10 active sites
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
First Submitted
Initial submission to the registry
December 22, 2017
CompletedFirst Posted
Study publicly available on registry
January 8, 2018
CompletedStudy Start
First participant enrolled
January 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 30, 2022
CompletedMay 18, 2022
May 1, 2022
3.7 years
December 22, 2017
May 17, 2022
Conditions
Outcome Measures
Primary Outcomes (5)
Congenital Abnormalities detected after birth as defined by the evolving definition of the congenital zika syndrome
Birth
Hearing abnormalities measured after birth
Between birth and 2 years
Visual abnormalities measured after birth
Between birth and 2 years
Developmental / cognitive abnormalities measured by the Ages and Stages 3rd Edition (ASQ3)
Between birth and 2 years
Developmental / cognitive abnormalities measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)
2 years
Eligibility Criteria
New born children
You may qualify if:
- Born within the Pregnant Woman cohort
- Born to mothers with confirmed ZIKA
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (10)
Sosecali Ltd. (SOSE)
Guaqui, Bolivia
Fundacao Oswaldo Cruz (FIOCRUZ)
Recife, Brazil
Fundacao Oswaldo Cruz (FIOCRUZ)
Rio de Janeiro, Brazil
University of Sao Paulo
São Paulo, Brazil
Industrial University of Santander (UIS)
Bucaramanga, Colombia
Pedro Kouri Institute (IPK)
Havana, Cuba
INSERM
Pointe-à-Pitre, Guadeloupe
IMSS Mexico (IMSS)
Guadalajara, Mexico
National Institute of Public Health (INSP)
Mérida, Mexico
Universidad de Carabobo / UMC Groningen (UMCG)
Valencia, Venezuela
Related Publications (1)
Avelino-Silva VI, Mayaud P, Tami A, Miranda MC, Rosenberger KD, Alexander N, Nacul L, Segurado A, Pohl M, Bethencourt S, Villar LA, Viana IFT, Rabello R, Soria C, Salgado SP, Gotuzzo E, Guzman MG, Martinez PA, Lopez-Gatell H, Hegewisch-Taylor J, Borja-Aburto VH, Gonzalez C, Netto EM, Saba Villarroel PM, Hoen B, Brasil P, Marques ETA, Rockx B, Koopmans M, de Lamballerie X, Jaenisch T; ZIKAlliance Clinical Study Group. Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium. BMC Infect Dis. 2019 Dec 26;19(1):1081. doi: 10.1186/s12879-019-4685-9.
PMID: 31878895DERIVED
Biospecimen
Blood, Hair, Urine, Vaginal fluids, Saliva, Semen
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PI
Study Record Dates
First Submitted
December 22, 2017
First Posted
January 8, 2018
Study Start
January 15, 2018
Primary Completion
September 30, 2021
Study Completion
March 30, 2022
Last Updated
May 18, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
1. The ZIKAlliance birth cohort is part of the 3 European Commission (EC) funded Zika consortia. The data are intended to be shared after the individual cohort data is analyzed and published. 2. The ZIKAlliance birth cohort is part of the WHO-moderated IPD meta-analysis Consortium. The data are intended to be shared after the individual cohort data is analyzed and published.