Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment (ZIKVIRUSIFF) (ZIKVIRUSIFF)
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ClinicalTrials.gov Identifier: NCT03255369 |
Recruitment Status : Unknown
Verified August 2017 by Oswaldo Cruz Foundation.
Recruitment status was: Recruiting
First Posted : August 21, 2017
Last Update Posted : May 3, 2018
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Condition or disease | Intervention/treatment |
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ZIKA VIRUS INFECTION Child Development Microcephaly | Other: Child exposed Zika virus proved |

Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 3 Years |
Official Title: | Vertical Exposure to Zika Virus and Its Consequences for Child Neurodevelopment: Cohort Study in Fiocruz/IFF |
Actual Study Start Date : | January 2, 2016 |
Estimated Primary Completion Date : | December 30, 2018 |
Estimated Study Completion Date : | December 30, 2019 |

Group/Cohort | Intervention/treatment |
---|---|
Child exposed Zika virus proved
child born to mothers with proved zika virus in pregnancy by RT-PCR
|
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected |
Child exposed to zika virus suspected
Child born with symptoms similar to babies proved exposed to zika virus but mothers without symptoms or positive RT-PCR
|
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected |
Normal Child
Normal child from mothers without Zika (IgG and IgM negative)
|
Other: Child exposed Zika virus proved
There will be applied Bayley Teste 3rd edition
Other Name: Child exposed Zika virus suspected |
- Microcephaly and/or delay in development [ Time Frame: 36 months of age ]Microcephaly at birth or delay in development in Bayley test 3rd edition at 12, 18 and between 24-36 months of age
- ocular injury and cognitive disorder in Bayley Test 3rd edition [ Time Frame: 36 months of age ]ocular injury in eye exam by indirect ophtalmoscopia registe by RetCam associated with cognitive disorder
- Hearing injury and language delay in Bayley Test 3rd edition [ Time Frame: 36 monthsof age ]deaphness or BERA abnomalities associated to language disorder
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | 2 Days to 3 Years (Child) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
The exposure will be confirmed by the positivity in diagnostic tests (PCR or serological tests).
Women with and without symptoms will have theirblood sampled for serological tests in the three trimesters of pregnancy and at birth.
The pregnant women in the cohort presenting positive results for specifictests (PCR in the acute phase and serological tests later) will be considered exposed to infection whereas pregnant women with negative results will be considered not exposed.
Inclusion Criteria:
The study population will be composed of pregnant women who present symptoms compatible with ZIKAV infection, with skin rash, arthralgia-associated fever, myalgia, non-purulent conjunctivitis, or headache and asymptomatic pregnant women identified at the same time of possibility of exposure. We will include patients with RT- PCR positive.
All pregnant women who are in the prenatal follow up at IFF and CSGSF, irrespective of the gestational age, are elegible as a not exposed in the beginning.
Children born during the outbreak by mothers with confirmed infection, suspected infection and normal pregnancy
Exclusion Criteria:
Pregnant women with chromosomal abnormalities detected during fetal life or birth will be excluded.
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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): NCT03255369
Contact: Maria E Moreira, MD | 552125541918 | bebeth@iff.fiocruz.br | |
Contact: Zilton Vasconcelos, PhD | 552125541919 | zvasconcelos@gmail.com |
Brazil | |
Instituto Fernandes Figueira/Fiocruz | Recruiting |
Rio de Janeiro, RJ, Brazil, 22250020 | |
Contact: Maria E Moreira, MD 552125541918 bebeth@iff.fiocruz.br | |
Contact: Marcos Pone, MD 552125541700 mpone@iff.fiocruz.br |
Principal Investigator: | Maria E Moreira, MD | Fundação Oswaldo Cruz |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Oswaldo Cruz Foundation |
ClinicalTrials.gov Identifier: | NCT03255369 |
Other Study ID Numbers: |
52675616.0.0000.5269 |
First Posted: | August 21, 2017 Key Record Dates |
Last Update Posted: | May 3, 2018 |
Last Verified: | August 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | we will share the data with Brazilian Minister of Health, WHO and European ZikaPlane consortium |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (CSR) Analytic Code |
Time Frame: | 3 years |
Access Criteria: | only the principal investigator |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Zika virus Microcephaly Child pregnancy |
Zika Virus Infection Microcephaly Virus Diseases Infections Arbovirus Infections Vector Borne Diseases Flavivirus Infections Flaviviridae Infections RNA Virus Infections |
Craniofacial Abnormalities Musculoskeletal Abnormalities Musculoskeletal Diseases Malformations of Cortical Development, Group I Malformations of Cortical Development Nervous System Malformations Nervous System Diseases Congenital Abnormalities |