ZIKAlliance Children Cohort (ZIKAllianceCH)

Zika Virus Clinical Trial

— ZIKAllianceCH  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03393286
• Other study ID #: 734548CH (EC | H2020 | RIA)
• Status: Completed
• Start date: January 15, 2018
• Est. completion date: March 30, 2022

Study information

• Verified date: May 2022
• Source: University of Heidelberg Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1554
• Est. completion date: March 30, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• Born within the Pregnant Woman cohort

• Born to mothers with confirmed ZIKA

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Zika Virus
• Zika Virus Infection

Locations

Country	Name	City	State
Bolivia	Sosecali Ltd. (SOSE)	Guaqui
Brazil	Fundacao Oswaldo Cruz (FIOCRUZ)	Recife
Brazil	Fundacao Oswaldo Cruz (FIOCRUZ)	Rio de Janeiro
Brazil	University of Sao Paulo	São Paulo
Colombia	Industrial University of Santander (UIS)	Bucaramanga
Cuba	Pedro Kouri Institute (IPK)	Havana
Guadeloupe	INSERM	Pointe-à-Pitre
Mexico	IMSS Mexico (IMSS)	Guadalajara
Mexico	National Institute of Public Health (INSP)	Mérida
Venezuela	Universidad de Carabobo / UMC Groningen (UMCG)	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Heidelberg Medical Center

Countries where clinical trial is conducted

Bolivia,  Brazil,  Colombia,  Cuba,  Guadeloupe,  Mexico,  Venezuela, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Congenital Abnormalities detected after birth as defined by the evolving definition of the congenital zika syndrome		Birth
Primary	Hearing abnormalities measured after birth		Between birth and 2 years
Primary	Visual abnormalities measured after birth		Between birth and 2 years
Primary	Developmental / cognitive abnormalities measured by the Ages and Stages 3rd Edition (ASQ3)		Between birth and 2 years
Primary	Developmental / cognitive abnormalities measured by the Bayley Scales of Infant and Toddler Development, Third Edition (BSID-III)		2 years