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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	24 August 2021
Main ID:	NCT02856984
Date of registration:	20/07/2016
Prospective Registration:	No
Primary sponsor:	RTI International
Public title:	Zika in Infants and Pregnancy (ZIP)
Scientific title:	International Prospective Observational Cohort Study of Zika in Infants
Date of first enrolment:	June 2016
Target sample size:	6461
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02856984
Study type:	Observational
Study design:
Phase:

Countries of recruitment
Brazil	Colombia	Guatemala	Nicaragua	Peru	Puerto Rico

Contacts

Name:	Ana Garces, MD
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Affiliation:	Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)

Name:	Marisa Elisabeth Lopes
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Affiliation:	Instituto Fernandes Figueira - FIOCRUZ

Name:	Eva Harris, PhD
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Affiliation:	University of Californina Berkeley

Name:	Teresa Ochoa Woodell, PhD
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Affiliation:	Universidad Peruana Cayetano Heredia

Name:	Marisa Mussi, MD
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Affiliation:	Ribeirão Preto Medical School, University of São Paulo

Name:	Juan F Arias, MD
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Affiliation:	St. Jude Children's Research Hospital

Name:	Jose Cordero, MD
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Affiliation:	University of Georgia

Name:	Carmen Milagros Velez Vega, PhD
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Affiliation:	University of Puerto Rico

Name:	George Seage, MD
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Affiliation:	Harvard University School of Public Health

Name:	Carmen Zorilla, MD
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Affiliation:	University of Puerto Rico

Name:	Albert Ko, MD
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Affiliation:	Yale University, Laboratory of Epidemiology and Public Health

Name:	Ricardo Ximenes, MD
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Affiliation:	Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE

Name:	Angel Balmaseda
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Affiliation:	MINSA Central

Name:	Jill Lebov, PhD
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Affiliation:	RTI International

Name:	William Britt, MD
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Affiliation:	University of Alabama Birmingham School of Medicine

Name:	Deolinda Scalabrin
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Affiliation:	Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS

Key inclusion & exclusion criteria

Inclusion Criteria:

- Informed consent

- Age >15 years

- Assent and consent as required per local country regulations

- Confirmation of pregnancy by beta human chorionic gonadotropin (hCG) measurement in
blood/urine or ultrasound confirmation of pregnancy with fetal heart tones present

- Pregnant women up to 17 weeks and 6 days gestation and subjects at any gestational age
with acute Zika infection, confirmed by serology or PCR (polymerase chain reaction)
test.

Exclusion Criteria: Pregnant Women

- Women who cannot adhere to proposed testing schedule

- Pregnant women enrolled in other research including other ZIKV research

Inclusion Criteria (newborn)

- All infants born to women enrolled in the observational cohort are eligible for
enrollment

Exclusion Criteria (newborn)

- Mother or custodial parent does not consent to have child participate

- Infants born to mothers that are not part of the ZIP cohort study

Age minimum: 15 Years
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Zika Virus Disease (Disorder)

Intervention(s)

Primary Outcome(s)

Incidence of adverse fetal outcomes for ZIKV infected participants [Time Frame: Time of birth of infant]

Incidence of adverse fetal outcomes for ZIKV infected participants [Time Frame: 3 months of age]

Incidence of congenital malformations for ZIKV symptomatic participants [Time Frame: 6 months of age]

Incidence of adverse fetal outcomes for ZIKV infected participants [Time Frame: 6 months of age]

Incidence of congenital malformations for ZIKV symptomatic participants [Time Frame: 3 months of age]

Incidence of adverse fetal outcomes for ZIKV symptomatic participants [Time Frame: Time of birth of infant]

Incidence of congenital malformations for ZIKV infected participants [Time Frame: 12 months of age]

Incidence of congenital malformations for ZIKV infected participants [Time Frame: 6 months of age]

Incidence of congenital malformations for ZIKV symptomatic participants [Time Frame: 12 months of age]

Incidence of adverse fetal outcomes for ZIKV infected participants [Time Frame: 12 months of age]

Incidence of adverse fetal outcomes for ZIKV symptomatic participants [Time Frame: 12 months of age]

Incidence of adverse fetal outcomes for ZIKV symptomatic participants [Time Frame: 3 months of age]

Incidence of congenital malformations for ZIKV infected participants [Time Frame: 3 months of age]

Incidence of adverse fetal outcomes for ZIKV symptomatic participants [Time Frame: 6 months of age]

Incidence of congenital malformations for ZIKV infected participants [Time Frame: Time of birth of infant]

Incidence of congenital malformations for ZIKV symptomatic participants [Time Frame: Time of birth of infant]

Secondary Outcome(s)

Secondary ID(s)

GN ZIKA

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

National Institute of Environmental Health Sciences (NIEHS)

National Institute of Allergy and Infectious Diseases (NIAID)

Oswaldo Cruz Foundation

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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