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Trial record 31 of 42 for:    Microcephaly

Zika in Infants and Pregnancy (ZIP)

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ClinicalTrials.gov Identifier: NCT02856984
Recruitment Status : Recruiting
First Posted : August 5, 2016
Last Update Posted : June 6, 2018
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Environmental Health Sciences (NIEHS)
Oswaldo Cruz Foundation
Information provided by (Responsible Party):
RTI International

Brief Summary:
The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of 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. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.

Condition or disease
Zika Virus Disease (Disorder)

Detailed Description:

The overall objective of this multisite, multicountry Zika in Infants and Pregnancy (ZIP) study is to assess the strength of the association between Zika virus infection (ZIKV) during pregnancy and adverse maternal/fetal outcomes and the risk of vertical transmission. The study will prospectively enroll a cohort of 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. The study will follow these women through their pregnancy to identify for clinical evidence of acute ZIKV, while controlling for potential confounders. Outcomes in the women, the developing fetus, and infants will be assessed. All protocol-specified data will be recorded and entered in a central data management system for the purposes of analysis of composite data from the study.

The study will recruit 10,000 pregnant women in their first trimester from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.


Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Prospective Observational Cohort Study of Zika in Infants
Study Start Date : June 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Zika Virus

Group/Cohort
ZIKV infected women
The study will prospectively enroll pregnant women up to 17 weeks and 6 days gestation and follow them through their pregnancy for clinical evidence of acute ZIKV infection while controlling for potential confounders. All pregnant women will be followed throughout the pregnancy, delivery, and 6 weeks postpartum. Outcomes in women, the developing fetus, and infants will be assessed.
Control (uninfected women)
The women who remain uninfected will serve as the internal comparison group. The infants who remain uninfected at delivery and throughout the follow-up period will serve as the internal comparison group.



Primary Outcome Measures :
  1. Incidence of congenital malformations for ZIKV infected participants [ Time Frame: Time of birth of infant ]
    To measure the incidence of congenital malformations in fetuses/infants.

  2. Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 3 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  3. Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 6 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  4. Incidence of congenital malformations for ZIKV infected participants [ Time Frame: 12 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  5. Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: Time of birth of infant ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  6. Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: 3 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  7. Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: 6 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  8. Incidence of adverse fetal outcomes for ZIKV infected participants [ Time Frame: 12 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, central nervous system (CNS) malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  9. Incidence of congenital malformations for ZIKV symptomatic participants [ Time Frame: Time of birth of infant ]
    To measure the incidence of congenital malformations in fetuses/infants.

  10. Incidence of congenital malformations for ZIKV symptomatic participants [ Time Frame: 3 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  11. Incidence of congenital malformations for ZIKV symptomatic participants [ Time Frame: 6 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  12. Incidence of congenital malformations for ZIKV symptomatic participants [ Time Frame: 12 months of age ]
    To measure the incidence of congenital malformations in fetuses/infants.

  13. Incidence of adverse fetal outcomes for ZIKV symptomatic participants [ Time Frame: Time of birth of infant ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  14. Incidence of adverse fetal outcomes for ZIKV symptomatic participants [ Time Frame: 3 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  15. Incidence of adverse fetal outcomes for ZIKV symptomatic participants [ Time Frame: 6 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.

  16. Incidence of adverse fetal outcomes for ZIKV symptomatic participants [ Time Frame: 12 months of age ]
    To measure the incidence of adverse fetal outcomes (including microcephaly, fetal demise, neonatal death, CNS malformations, hydrops, and ocular abnormalities) in fetuses/infants.


Biospecimen Retention:   Samples Without DNA
maternal samples from urine, blood, genital secretions, saliva, and breast milk, and when available amniotic fluid and tissue; infant urine, blood, and saliva


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
The study will recruit 10,000 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 from ZIKV-endemic regions and follow them longitudinally to study the impact of incident ZIKV during pregnancy on maternal, fetal, and newborn outcomes. Researchers will identify cases of incident ZIKV among pregnant women by monitoring for symptoms of Zika-like illness and performing serial laboratory sampling for diagnosis of seroconversion and viral shedding. After delivery, infants born with evidence of ZIKV or born to mothers diagnosed with incident virus infection will be followed in a prospective longitudinal cohort for at least 1 year. In addition, a control group of infants born to mothers without evidence of ZIKV during pregnancy will be followed.
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

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): NCT02856984


Contacts
Contact: Nahida Chakhtoura,, MD (301) 435-6872 nahida.chakhtoura@nih.gov
Contact: Walla Dempsey, PhD (240) 292-4197 WDEMPSEY@niaid.nih.gov

Locations
Brazil
Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS; Rue Waldemar Falcao Recruiting
Salvador, Bahia, Brazil, 40296-710
Contact: Deolinda Scalabrin       deolindascalabrin@gmail.com   
Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE Recruiting
Recife, PE, Brazil, CEP: 50670-901
Contact: Ricardo Ximenes, MD       raaximenes@uol.com.br   
Instituto Fernandes Figueira - FIOCRUZ Recruiting
Rio de Janeiro, RJ, Brazil, 22250-020
Contact: Maria E Lopes       bebeth@iff.fiocruz.br   
Ribeirão Preto Medical School, University of São Paulo, Av. Bandeirantes, 3900 - Monte Alegre Recruiting
Ribeirão Preto, SP, Brazil, 14049-900
Contact: Marisa M Mussi, MD       mmmpinha@fmrp.usp.br   
Colombia
Universidad de Antioquia Recruiting
Medellín, Colombia
Contact: Alexander Martinez       alexander.martinez@imbanaco.com.co   
Guatemala
Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP) Recruiting
Guatemala, Guatemala
Contact: Ana Garces, MD       agarces@incap.int   
Nicaragua
MINSA Central Recruiting
Managua, Nicaragua, 16064
Contact: Angel Balmaseda       abalmaseda@minsa.gob.ni   
Peru
Universidad Peruana Recruiting
Lima, Peru
Contact: Theresa O Woodell       theresa.ochoa@upch.pe   
Puerto Rico
University of Puerto Rico Medical Sciences Campus Recruiting
San Juan, Puerto Rico, 00921
Contact: Carmen Milagros Velez Vega       carmen.velez2@upr.edu   
University of Puerto Rico - Recinto de Río Piedras Recruiting
San Juan, Puerto Rico, 00936
Contact: Carmen Zorilla       carmen.zorrilla@upr.edu   
Sponsors and Collaborators
RTI International
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institute of Allergy and Infectious Diseases (NIAID)
National Institute of Environmental Health Sciences (NIEHS)
Oswaldo Cruz Foundation
Investigators
Principal Investigator: Ricardo Ximenes, MD Departamento de Medicina Tropical da Universidade Federal de Pernambuco-UFPE
Principal Investigator: William Britt, MD University of Alabama Birmingham School of Medicine
Principal Investigator: Marisa Mussi, MD Ribeirão Preto Medical School, University of São Paulo
Principal Investigator: Albert Ko, MD Yale University, Laboratory of Epidemiology and Public Health
Principal Investigator: Deolinda Scalabrin Centro de Pesquisas Gonçalo Moniz, Fundação Oswaldo Cruz/MS
Principal Investigator: Marisa Elisabeth Lopes Instituto Fernandes Figueira - FIOCRUZ
Principal Investigator: Ana Garces, MD Fundación para la Alimentación y Nutrición de Centro América y Panamá (INCAP)
Principal Investigator: Jose Cordero, MD University of Georgia
Principal Investigator: Carmen Milagros Velez Vega University of Puerto Rico
Principal Investigator: George Seage, MD Harvard University School of Public Health
Principal Investigator: Carmen Zorilla University of Puerto Rico
Principal Investigator: Eva Harris University of Californina Berkeley
Principal Investigator: Angel Balmaseda MINSA Central
Principal Investigator: Ivan Dario Velez Universidad de Antioquia
Principal Investigator: Jill Leboov, PhD RTI International
Principal Investigator: Alexander Martinez Universidad de Antioquia
Principal Investigator: Teresa O Woodell Universidad Peruana

Publications of Results:

Other Publications:
WHO statement on the first meeting of the International Health Regulations (2005) (IHR 2005) Emergency Committee on Zika virus and observed increase in neurological disorders and neonatal malformations; 1 February 2016. Available at http://www.who.int/ mediacentre/news/statements/2016/1st-emergency-committee-zika/en/
CDC. Chikungunya virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/chikungunya/hc/clinicalevaluation.html
CDC Zika Virus; Areas with Zika http://www.cdc.gov/zika/geo/index.html
CDC. West Nile virus: insect repellent use & safety. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/westnile/faq/repellent.html.
CDC. Zika virus. Atlanta, GA: US Department of Health and Human Services, CDC; 2015. http://www.cdc.gov/zika/index.html
http://www.salud.gov.pr/Estadisticas-Registros-y-Publicaciones/Informes %20Arbovirales/Reporte%20ArboV%20semana%204-2016.pdf
Julie A Boom; Microcephaly in infants and children: Etiology and evaluation UpToDate http://www.uptodate.com/contents/microcephaly-in-infants-and-children- etiology-and-evaluation?source=machineLearning&search=microcephaly+in +pregnacy&selectedTitle=2~130§ionRank=3&anchor=H55603463#H55603463 Accessed on February 16, 2016
Medscape Medical News; FDA Issues Guidance to Protect Blood Supply From Zika Virus http://www.medscape.com/viewarticle/858976? nlid=100283_3901&src=wnl_newsalrt_160216_MSCPEDIT&uac=17333MK&impID=993653&faf=1

Responsible Party: RTI International
ClinicalTrials.gov Identifier: NCT02856984     History of Changes
Other Study ID Numbers: GN ZIKA
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: June 6, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: de-identified participant data will be entered into the National Institute of Child Health and Human Development (NICHD) Data and Specimen Hub (N-DASH) system.

Keywords provided by RTI International:
Pregnancy
Infant

Additional relevant MeSH terms:
Virus Diseases
Zika Virus Infection
Disease
Arbovirus Infections
Flavivirus Infections
Flaviviridae Infections
RNA Virus Infections
Pathologic Processes