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ZIKAlliance Children Cohort (ZIKAllianceCH) (ZIKAllianceCH)

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ClinicalTrials.gov Identifier: NCT03393286
Recruitment Status : Recruiting
First Posted : January 8, 2018
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Thomas Jaenisch, University of Heidelberg Medical Center

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.

Condition or disease
Zika Virus

Detailed Description:

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.

The study will also determine the ZIKV maternal to child transmission rate and evaluate co-factors or effect modifiers that account for the large variability seen in the preliminary absolute risk estimates derived from population figures and reporting of microcephaly in different states in Brazil and across Latin America.

The study will carry out a pregnant women (PW) multicentre cohort study in areas across Latin America and the Caribbean. Women will be enrolled early in pregnancy and followed every 4 weeks, in connection with their routine antenatal care visits. At each visit, urine and blood samples will be collected, tested and stored.

Among PW reporting recent or current undifferentiated fever/rash syndrome at any point in time, the acute illness episode will be characterized in greater detail. PW with suspected ZIKV infection (i.e. meeting the Pan American Health Organization (PAHO) clinical case definition) during pregnancy will be managed according to national protocols. Irrespective of symptoms, pregnant women will be followed prospectively and revisited at birth (or after abortion) for a detailed documentation of the outcome of their pregnancy.

Live newborns will receive a detailed neonatal examination. In the course of examination of the newborns, biological samples will be collected and stored. Other potential causes of congenital abnormalities (TORCHS infections in the mother, toxic substances, chromosomal abnormalities), and potential effect modifiers (for example past flavivirus infections/vaccinations, socio-economic status) will also be assessed.

With appropriate counselling and consent, biological samples of newborns with severe abnormalities, deceased newborns, stillborn babies, and aborted foetuses from ZIKV-infected mothers will be collected to help elucidate the aetiological contribution of ZIKV in neurological and other congenital malformations.

Children of women infected with ZIKV during pregnancy - and a subset of the children born to uninfected women - will be followed prospectively after birth for the assessment of neuro-developmental milestones.

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Study Type : Observational
Estimated Enrollment : 5000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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
Actual Study Start Date : January 15, 2018
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : September 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus




Primary Outcome Measures :
  1. Congenital Abnormalities detected after birth as defined by the evolving definition of the congenital zika syndrome [ Time Frame: Birth ]
  2. Hearing abnormalities measured after birth [ Time Frame: Between birth and 2 years ]
  3. Visual abnormalities measured after birth [ Time Frame: Between birth and 2 years ]
  4. Developmental / cognitive abnormalities measured by the Ages and Stages 3rd Edition (ASQ3) [ Time Frame: Between birth and 2 years ]
  5. Developmental / cognitive abnormalities measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III) [ Time Frame: 2 years ]

Biospecimen Retention:   Samples With DNA
Blood, Hair, Urine, Vaginal fluids, Saliva, Semen


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 6 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
New born children
Criteria

Inclusion Criteria:

  • Born within the Pregnant Woman cohort
  • Born to mothers with confirmed ZIKA

Exclusion Criteria:

-


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03393286


Contacts
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Contact: Thomas Jänisch +49 6221 56 38040 thomas.jaenisch@urz.uni-heidelberg.de

Locations
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Bolivia
Sosecali Ltd. (SOSE) Not yet recruiting
Guaqui, Bolivia
Contact: Carmen Soria         
Contact: Eduardo Jurado         
Brazil
Fundacao Oswaldo Cruz (FIOCRUZ) Not yet recruiting
Recife, Brazil
Contact: Ernesto Marques       marques@pitt.edu   
Contact: Isabel Viana       isabelle.viana@cpqam.fiocruz.br   
Fundacao Oswaldo Cruz (FIOCRUZ) Not yet recruiting
Rio de Janeiro, Brazil
Contact: Patricia Brasil       patricia.brasil@ipec.fiocruz.br   
Contact: Renata Rabello       renata.rabello@ini.fiocruz.br   
University of Sao Paulo Recruiting
São Paulo, Brazil
Contact: Vivian Avelino-Silva       vivian87@usp.br   
Contact: Aluisio Cotrim Segurado       segurado@usp.br   
Colombia
Industrial University of Santander (UIS) Recruiting
Bucaramanga, Colombia
Contact: Luis Villar         
Contact: Maria Consuelo Miranda         
Cuba
Pedro Kouri Institute (IPK) Not yet recruiting
Havana, Cuba
Contact: Eric Martinez         
Guadeloupe
INSERM Recruiting
Pointe-à-Pitre, Guadeloupe
Contact: Bruno Hoen         
Mexico
IMSS Mexico (IMSS) Recruiting
Guadalajara, Mexico
Contact: Victor Hugo Borja-Aburto       victor.borja@imss.gob.mx   
Contact: Cesar Gonzalez       Cesar.gonzalezb@imss.gob.mx   
National Institute of Public Health (INSP) Recruiting
Mérida, Mexico
Contact: Hugo Lopez-Gatell       hugo.lopez-gatell@insp.mx   
Contact: Jennifer Hegewitsch       jennifer.hegewisch@insp.mx   
Venezuela
Universidad de Carabobo / UMC Groningen (UMCG) Recruiting
Valencia, Venezuela
Contact: Adriana Tami-Grundmann       a.tami@umcg.nl   
Contact: Sarah Bethencourt         
Sponsors and Collaborators
University of Heidelberg Medical Center
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Jaenisch, PI, University of Heidelberg Medical Center
ClinicalTrials.gov Identifier: NCT03393286    
Other Study ID Numbers: 734548CH (EC | H2020 | RIA)
First Posted: January 8, 2018    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:
  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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Zika Virus Infection
Arbovirus Infections
Virus Diseases
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections