Evidence map›Paper›PMID 31878895›Full record

Observational studyBMC infectious diseases2019

Study protocol for the multicentre cohorts of Zika virus infection in pregnant women, infants, and acute clinical cases in Latin America and the Caribbean: the ZIKAlliance consortium.

Vivian I Avelino-Silva, Philippe Mayaud, Adriana Tami, Maria C Miranda, Kerstin D Rosenberger, Neal Alexander, Luis Nacul, Aluisio Segurado, Moritz Pohl, Sarah Bethencourt and 22 more

3 registry-linked trialsOpen access · goldAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in BMC infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 3 registered trials, which are not on this map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 pooled it
2.2field-weighted citation impact, top 12% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03188731 completednot on this map

Pregnant Women (PW) Cohort for Evaluation of Risks of Congenital Malformations and Other Adverse Pregnancy Outcomes After Zika Virus Infection (Part of ZIKAlliance)

TypeobservationalSponsorUniversity of Heidelberg Medical CenterRan2017 to 2021Enrolled3,852ConditionsZika Virus, Pregnancy Related
NCT03204409 withdrawnnot on this map

Longitudinal Clinical and Virological Study Among Symptomatic Patients With Zika Virus Infection in the City of Sao Paulo, Brazil

TypeobservationalSponsorUniversity of Heidelberg Medical CenterRan2018 to 2021Enrolled0ConditionsZika Virus, Zika Virus Infection
NCT03393286 completednot on this map

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

TypeobservationalSponsorUniversity of Heidelberg Medical CenterRan2018 to 2022Enrolled1,554ConditionsZika Virus
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 1 synthesis or guideline pooled it, 14 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Article
  4. Article
  5. Observational
  6. Review
  7. Article
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

32 authors at 19 institutions in 14 countries.

Vivian I Avelino-SilvaDepartment of Infectious and Parasitic Diseases and Instituto de Medicina Tropical, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Philippe MayaudLondon School of Hygiene and Tropical Medicine, London, UK.
Adriana TamiDepartment of Medical Microbiology, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
Maria C MirandaUniversidad Industrial de Santander, Bucaramanga, Colombia.
Kerstin D RosenbergerDepartment of Infectious Diseases, Section Clinical Tropical Medicine, Heidelberg University Hospital, INF 324, 69120, Heidelberg, Germany.
Neal AlexanderLondon School of Hygiene and Tropical Medicine, London, UK.
Luis NaculLondon School of Hygiene and Tropical Medicine, London, UK.
Aluisio SeguradoDepartment of Infectious and Parasitic Diseases and Instituto de Medicina Tropical, Faculdade de Medicina da Universidade de Sao Paulo, Sao Paulo, Brazil.
Moritz PohlInstitute of Medical Biometry and Informatic, Heidelberg University Hospital, Heidelberg, Germany.
Sarah BethencourtFacultad de Ciencias de la Salud, Universidad de Carabobo, Valencia, Venezuela.
Luis A VillarUniversidad Industrial de Santander, Bucaramanga, Colombia.
Isabelle F T VianaAggeu Magalhães Institute, Oswaldo Cruz Foundation (FIOCRUZ), Recife, Brazil.
Renata RabelloEvandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
Carmen SoriaUniversidad Católica Santiago de Guayaquil, Guayaquil, Ecuador.
Silvia P SalgadoInstituto Nacional de Investigación en Salud Pública "Dr. Leopoldo Izquieta Pérez", (INSPI), Guayaquil, Ecuador.
Eduardo GotuzzoInstituto de Medicina Tropical Alexander von Humboldt, Universidad Peruana Cayetano Heredia, Lima, Peru.
María G GuzmánPedro Kouri Tropical Medicine Institute (IPK), Havana, Cuba.
Pedro A MartínezPedro Kouri Tropical Medicine Institute (IPK), Havana, Cuba.
Hugo López-GatellCentro de Investigación sobre Enfermedades Infecciosas, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.
Jennifer Hegewisch-TaylorCentro de Investigación sobre Enfermedades Infecciosas, Instituto Nacional de Salud Pública, Cuernavaca, Mexico.
Victor H Borja-AburtoMexican Institute of Social Security, Mexico City, Mexico.
Cesar GonzalezMexican Institute of Social Security, Mexico City, Mexico.
Eduardo M NettoFederal University of Bahia, Salvador, Brazil.
Paola M Saba VillarroelCentro Nacional de Enfermedades Tropicales (CENETROP), Santa Cruz, de la Sierra, Bolivia.
Bruno HoenINSERM Centre d'Investigation Clinique 1424, Centre Hospitalier Universitaire de Pointe-à-Pitre, Pointe-à-Pitre, France.
Patrícia BrasilEvandro Chagas National Institute of Infectious Diseases, Oswaldo Cruz Foundation (FIOCRUZ), Rio de Janeiro, Brazil.
Ernesto T A MarquesUniversity of Pittsburgh, Center for Vaccine Research, Pittsburgh, PA, USA.
Barry RockxDepartment of Viroscience, WHO CC Arbovirus and hemorrhagic fever viruses reference and research, Erasmus MC, Rotterdam, The Netherlands.
Marion KoopmansDepartment of Viroscience, WHO CC Arbovirus and hemorrhagic fever viruses reference and research, Erasmus MC, Rotterdam, The Netherlands.
Xavier de LamballerieAix-Marseille University, Marseille, France.
Thomas JaenischDepartment of Infectious Diseases, Section Clinical Tropical Medicine, Heidelberg University Hospital, INF 324, 69120, Heidelberg, Germany. thomas.jaenisch@urz.uni-heidelberg.de.ORCID http://orcid.org/0000-0001-8252-7444
ZIKAlliance Clinical Study Group
Fundação Oswaldo Cruz · BRHeidelberg University · DELondon School of Hygiene & Tropical Medicine · GBErasmus MC · NLHospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo · BRIndustrial University of Santander · COInstituto de Medicina Tropical “Pedro Kourí” · CUInstituto Nacional de Salud Pública · MXMexican Social Security Institute · MXAix-Marseille Université · FRCentro Nacional de Enfermedades Tropicales · BOInserm · FRInstituto Nacional de Investigación en Salud Pública · ECUniversidad Católica de Santiago de Guayaquil · ECUniversidade Federal da Bahia · BRUniversidad Peruana Cayetano Heredia · PEUniversity Medical Center Groningen · NLUniversity of Carabobo · VEUniversity of Pittsburgh · US

Funding

Yale Clinical and Translational Science Award (U Component)UL1TR001863 · NCATS · YALE UNIVERSITY · PI John H. Krystal, LUCILA OHNO-MACHADO · 2016 to 2026
$102.9M
Horizon 2020 734548NCATS NIH HHS UL1 TR001863
6 · The paper itself

Abstract

backgroundThe European Commission (EC) Horizon 2020 (H2020)-funded ZIKAlliance Consortium designed a multicentre study including pregnant women (PW), children (CH) and natural history (NH) cohorts. Clinical sites were selected over a wide geographic range within Latin America and the Caribbean, taking into account the dynamic course of the ZIKV epidemic.

methodsRecruitment to the PW cohort will take place in antenatal care clinics. PW will be enrolled regardless of symptoms and followed over the course of pregnancy, approximately every 4 weeks. PW will be revisited at delivery (or after miscarriage/abortion) to assess birth outcomes, including microcephaly and other congenital abnormalities according to the evolving definition of congenital Zika syndrome (CZS). After birth, children will be followed for 2 years in the CH cohort. Follow-up visits are scheduled at ages 1-3, 4-6, 12, and 24 months to assess neurocognitive and developmental milestones. In addition, a NH cohort for the characterization of symptomatic rash/fever illness was designed, including follow-up to capture persisting health problems. Blood, urine, and other biological materials will be collected, and tested for ZIKV and other relevant arboviral diseases (dengue, chikungunya, yellow fever) using RT-PCR or serological methods. A virtual, decentralized biobank will be created. Reciprocal clinical monitoring has been established between partner sites. Substudies of ZIKV seroprevalence, transmission clustering, disabilities and health economics, viral kinetics, the potential role of antibody enhancement, and co-infections will be linked to the cohort studies. DISCUSSION: Results of these large cohort studies will provide better risk estimates for birth defects and other developmental abnormalities associated with ZIKV infection including possible co-factors for the variability of risk estimates between other countries and regions. Additional outcomes include incidence and transmission estimates of ZIKV during and after pregnancy, characterization of short and long-term clinical course following infection and viral kinetics of ZIKV. STUDY REGISTRATIONS: clinicaltrials.gov NCT03188731 (PW cohort), June 15, 2017; clinicaltrials.gov NCT03393286 (CH cohort), January 8, 2018; clinicaltrials.gov NCT03204409 (NH cohort), July 2, 2017.

Indexed as

AdultArbovirusesCaribbean RegionChildChild, PreschoolCohort StudiesCoinfectionFemaleFollow-Up StudiesHumansInfantLatin AmericaMicrocephalyPregnancyPregnancy Complications, InfectiousPrenatal CareArbovirusesCaribbeanChildrenCohortCongenital abnormalitiesLatin AmericaMosquito-borne virusesNatural historyPregnant womenRiskVector-borne virusesZika

Identifiers

PMID31878895
PMCPMC6933915
OpenAlexW2997629651

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.