NCT03922594

Brief Summary

This study will explore whether ZIKV is currently responsible for neurological complications, and particularly microcephaly, in Aedes-infested regions of Sub-Saharan Africa (SSA) and Asia. This will inform regional public health strategies, such as vaccination of women of child-bearing age. It will also demonstrate the public health impact of ZIKV infection and increase the understanding of other regional infectious (e.g. cytomegalovirus) causes of microcephaly.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Typical duration for all trials

Geographic Reach
5 countries

8 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 17, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 22, 2019

Completed
28 days until next milestone

Study Start

First participant enrolled

May 20, 2019

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2021

Completed
Last Updated

May 20, 2022

Status Verified

March 1, 2022

Enrollment Period

2.3 years

First QC Date

April 17, 2019

Last Update Submit

May 16, 2022

Conditions

MicrocephalyCongenital Infection

Outcome Measures

Primary Outcomes (3)

  • Incidence of microcephaly (per 10,000 live births)

    Incidence of microcephaly (per 10,000 live births)

    At birth

  • Proportion of microcephaly attributable to ZIKV

    Proportion of microcephaly attributable to Zika virus infection

    At birth

  • Proportion of microcephaly linked to other infectious etiologies

    Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)

    At birth

Study Arms (5)

Cameroon

Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

China

Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

Ivory Coast

Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex and severely disproportionate length or weight according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

Sri Lanka

Live newborns with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

Vietnam

Fetuses or newborns (still-born, medical abortions or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns

Diagnostic Test: Differential diagnosis for infectious causes of microcephaly

Interventions

Differential diagnosis for infectious causes of microcephalyDIAGNOSTIC_TEST

Zika virus, cytomegalovirus, rubella, toxoplasmosis

CameroonChinaIvory CoastSri LankaVietnam

Eligibility Criteria

Age0 Days - 2 Days
Sexall
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Fetuses or newborns (still-born, medical abortions \[China and Vietnam only\] or alive) with microcephaly defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex with abnormal ultrasound and/or clinical examination findings for newborns.

You may qualify if:

  • All infants or fetuses with microcephaly, (defined as head circumference ≤-3SD according to INTERGROWTH standards for gestational age and sex, detected during the mother's pregnancy, or at the end of the mother's pregnancy at one of the participating maternities)
  • and with abnormal ultrasound and/or clinical examination findings for newborns.

You may not qualify if:

  • Infants/fetuses with microcephaly whose mothers are under the age of 18 years,
  • or inability or refusal of mothers/ guardians to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Central Hospital Maternity

Yaoundé, Cameroon

Location

Essos Hospital Centre Maternity

Yaoundé, Cameroon

Location

Guangzhou Women's and Children's Hospital

Guangzhou, China

Location

General Hospital Abobo-Sud

Abidjan, Côte d’Ivoire

Location

General Hospital of Yopougon-Attie

Abidjan, Côte d’Ivoire

Location

Castle Street Hospital for Women

Colombo, Sri Lanka

Location

De Soyza Hospital for Women

Colombo, Sri Lanka

Location

Tu Du Hospital

Ho Chi Minh City, Vietnam

Location

MeSH Terms

Conditions

Microcephaly

Interventions

Diagnosis, Differential

Condition Hierarchy (Ancestors)

Craniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesMalformations of Cortical Development, Group IMalformations of Cortical DevelopmentNervous System MalformationsNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Diagnosis

Study Officials

  • Arnaud Fontanet

    Institut Pasteur

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Days
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2019

First Posted

April 22, 2019

Study Start

May 20, 2019

Primary Completion

August 31, 2021

Study Completion

August 31, 2021

Last Updated

May 20, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(2)SR(2)VN(1)CN(1)CÔ(2)