An observational study in Microcephaly and Congenital Infection, sponsored by Institut Pasteur. Terminated at 8 sites in 5 countries. Open to participants aged 0 Days to 2 Days. Per ClinicalTrials.gov, last updated 2022-05-20.
Sponsored by Institut Pasteur · Observational
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.
This study will last for 2 years, and will include only new cases of microcephaly.
Surveillance will take place in large maternities in urban areas (standard procedure)
Data collection (study activity)
Analysis and reporting (study activity)
o All results will be shared publically through conferences and peer-reviewed publications.
22 studies on the registry are indexed under Microcephaly; 5 are open to participants now.
This study's enrollment of 150 is below the median of 232 across 16 observational studies indexed under Microcephaly.
Browse Microcephaly studies →Institut Pasteur is the lead sponsor of 99 studies on the registry; 41 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
Zika virus, cytomegalovirus, rubella, toxoplasmosis
Incidence of microcephaly (per 10,000 live births)
Incidence of microcephaly (per 10,000 live births)
Time frame: At birth
Proportion of microcephaly attributable to ZIKV
Proportion of microcephaly attributable to Zika virus infection
Time frame: At birth
Proportion of microcephaly linked to other infectious etiologies
Proportion of microcephaly linked to other infectious etiologies (non-ZIKV)
Time frame: At birth
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2019 to primary completion in Aug 2021, 27 months.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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