MicrocephalyZENINCT02943304
Neurodevelopment Outcome of Newborns Exposed to Zika Virus (ZIKV) in Utero
An observational study of Microcephaly and Mental Retardation, run by Universidad Industrial de Santander at 1 site in Colombia.
Trial summary
This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Read more about this study
- Who is it for?
- Ages 13 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Microcephaly, Mental Retardation
- What is being tested?
- Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
- How many people
- 284 participants
- Where
- 1 siteColombia
- Study dates
- 1 May 2016to 20 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia
Who may be able to join
- Pregnant women who on their first prenatal visit (independent of gestational age) confirm through a pre-designed questionnaire that they have had any symptom(s) compatible with ZIKV infection (rash [exanthema or sprout], conjunctivitis, arthralgia or myalgia, fever). Pregnant women with an affirmative response will be categorized in two groups:
- Acute Infection: symptoms of ZIKV infection that occurred within the previous 14 days of the day the pregnant women attended her prenatal visit.
- Late Infection: symptoms of ZIKV infection that occurred more then 14 days from her prenatal visit. Gestational age of onset of symptomatology will be documented at this time.
- Pregnant women without symptoms of ZIKV infection who have a negative RT-PCR for ZIKV and a negative specific serologic test for ZIKV at initial prenatal visit with normal prenatal evaluation. These pregnant women will be selected from non high-risk delivery services.
Who cannot join
- Eligible pregnant women that refuse to sign consent for participation in the ZEN Initiative.
- Enrolled pregnant women that withdraw their consent to participate at any time in the study.
Trial locations and contacts
1 site in 1 country.
Colombia1 site
Hospital Universitario de Santander
Bucaramanga, Santander Department, 68001
About this study
Official title: Risk Evaluation of Fetal Nervous System and Neurodevelopment Disorders in Infants of Women Exposed to Zika Virus Infection During Pregnancy
This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.
Read the detailed description
Infection with Zika Virus (ZIKV) is an emerging disease in South America and a serious public health problem due to a high prevalence of one of the vectors that transmit the virus, Aedes Aegypti, and the severe and sometimes fatal complications that can be generated in the fetus of women infected by the virus during their pregnancy. Retrospective studies have shown an association with microcephaly, cerebral calcifications, dysgenesis of the corpus callosum, and other anomalies of the central nervous system (CNS). The high risk of neurodevelopmental impairment in the exposed newborn is a major concern.
The epidemiologic and neurobiological evidence supporting the link between infection of pregnant women, trimester of infection, and the development of such anomalies in the fetus is growing to the extent that the Center for Disease Control has officially made a statement supporting this association. Although the dimension of the public health impact is still unknown, limited prospective data makes counseling of pregnant women difficult, especially when they are considering termination of pregnancy.
Given that evidence supporting the neurotropic quality of ZIKV and the potential variations of the effect the virus may have on the developing fetal brain according to the gestational age of infection, we have designed a prospective cohort study to determine whether exposure of the fetus to ZIKV in symptomatic mothers results in fetal CNS anomalies and/or impaired neurodevelopmental outcome of the newborn. As a secondary aim we will determine the effect gestational age has on severity of CNS anomalies and neurodevelopmental outcome.
- Conditions
- Microcephaly, Mental Retardation
- Being tested
- Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV
- Keywords
- Pregnancy, Fetal Development, Child Development, Developmental Disabilities, Zika Virus Infection
- Medical subject headings
- Microcephaly, Intellectual Disability, Developmental Disabilities, Zika Virus Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKVOther
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV Receives: Other: Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV | |
| Unexposed | Asymptomatic pregnant women with a negative RT-PCR ZIKV in serum and urine, and a negative specific serology for ZIKV at enrollment into the study and at the time of delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurodevelopmental Outcome
Bayley Scales of Infant and Toddler Development Third Edition
Measured: 24 months corrected age
Secondary outcomes (1)
Fetal CNS Impairment
Prenatal Level III Ultrasound Identification of Fetal CNS Abnormalities
Measured: Until Birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2016 (estimated)
- Study start1 May 2016
- Primary completion15 Dec 2020
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MicrocephalyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Industrial de Santander
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Responsible party
- Principal investigator, Mario Augusto Rojas, Universidad Industrial de Santander
- Investigators
- Mario A Rojas, MD, MPH, Principal investigator, Professor of PediatricsLuz A Gutierrez, MD, Study director, Universidad Industrial de SantanderLuis A Diaz, MD, MSc, Study chair, Universidad Industrial de Santander
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943304
- Sponsor's protocol ID
- 4110
- Acronym
- ZENI
- Status last verified
- Jan 2023
- First submitted
- 20 Oct 2016
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Diaz-Martinez LA, Rojas MA, Pinilla-Garcia LS, Becerra-Mojica CH, Perez-Vera LA, Gutierrez-Sanchez LA, Contreras-Garcia GA, Rueda-Ordonez CG, Villar L. Neurodevelopmental outcome of infants without central nervous system anomalies born to symptomatic RT-PCR ZIKV positive women. PLoS Negl Trop Dis. 2022 Mar 7;16(3):e0009854. doi: 10.1371/journal.pntd.0009854. eCollection 2022 Mar.
PubMed 35255097
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Evaluation of Fetal Nervous System and Neurodevelopment Disorders in Infants of Women Exposed to Zika Virus Infection During Pregnancy
- ClinicalTrials.gov ID
- NCT02943304
- Acronym / sponsor ID
- ZENI / 4110
- Conditions
- Microcephaly, Mental Retardation
- Keywords
- Pregnancy, Fetal Development, Child Development, Developmental Disabilities, Zika Virus Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Universidad Industrial de SantanderUniversity, hospital or other
- Collaborators
- University of North Carolina, Chapel Hill
- Study start
- 1 May 2016 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 24 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective cohort study will determine the natural history of fetal exposure to Zika virus (ZIKV) and its effects on the fetus and newborn with emphasis on neurodevelopment outcome. Exposure of the fetus will be determined by maternal symptomatology, RT-PCR ZIKV (blood and urine) and serologic test specific for ZIKV. Neonates will be classified according to trimester of infection and as exposed and unexposed to ZIKV.
Detailed description
Infection with Zika Virus (ZIKV) is an emerging disease in South America and a serious public health problem due to a high prevalence of one of the vectors that transmit the virus, Aedes Aegypti, and the severe and sometimes fatal complications that can be generated in the fetus of women infected by the virus during their pregnancy. Retrospective studies have shown an association with microcephaly, cerebral calcifications, dysgenesis of the corpus callosum, and other anomalies of the central nervous system (CNS). The high risk of neurodevelopmental impairment in the exposed newborn is a major concern.
The epidemiologic and neurobiological evidence supporting the link between infection of pregnant women, trimester of infection, and the development of such anomalies in the fetus is growing to the extent that the Center for Disease Control has officially made a statement supporting this association. Although the dimension of the public health impact is still unknown, limited prospective data makes counseling of pregnant women difficult, especially when they are considering termination of pregnancy.
Given that evidence supporting the neurotropic quality of ZIKV and the potential variations of the effect the virus may have on the developing fetal brain according to the gestational age of infection, we have designed a prospective cohort study to determine whether exposure of the fetus to ZIKV in symptomatic mothers results in fetal CNS anomalies and/or impaired neurodevelopmental outcome of the newborn. As a secondary aim we will determine the effect gestational age has on severity of CNS anomalies and neurodevelopmental outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Other: Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKVSymptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV |
| Unexposed | – | –Asymptomatic pregnant women with a negative RT-PCR ZIKV in serum and urine, and a negative specific serology for ZIKV at enrollment into the study and at the time of delivery |
Who may qualify
- Ages
- 13 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- ZIKV symptomatic and asymptomatic pregnant women in hyper endemic areas of ZIKV in Colombia
Key inclusion criteria (4 listed)
- Pregnant women who on their first prenatal visit (independent of gestational age) confirm through a pre-designed questionnaire that they have had any symptom(s) compatible with ZIKV infection (rash [exanthema or sprout], conjunctivitis, arthralgia or myalgia, fever). Pregnant women with an affirmative response will be categorized in two groups:
- Pregnant women without symptoms of ZIKV infection who have a negative RT-PCR for ZIKV and a negative specific serologic test for ZIKV at initial prenatal visit with normal prenatal evaluation. These pregnant women will be selected from non high-risk delivery services.
Key exclusion criteria (2 listed)
- Eligible pregnant women that refuse to sign consent for participation in the ZEN Initiative.
- Enrolled pregnant women that withdraw their consent to participate at any time in the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Symptomatic pregnant women with positive RT-PCR ZIKV in serum or urine, or a positive serologic test specific for ZIKV | Other | Exposed |
Primary outcome
Neurodevelopmental Outcome
Time frame: 24 months corrected age
Bayley Scales of Infant and Toddler Development Third Edition
1 secondary outcome
Fetal CNS Impairment
Time frame: Until Birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- Derived from this study: PubMed 35255097Diaz-Martinez LA, Rojas MA, Pinilla-Garcia LS, Becerra-Mojica CH, Perez-Vera LA, Gutierrez-Sanchez LA, Contreras-Garcia GA, Rueda-Ordonez CG, Villar L. Neurodevelopmental outcome of infants without central nervous system anomalies born to symptomatic RT-PCR ZIKV positive women. PLoS Negl Trop Dis. 2022 Mar 7;16(3):e0009854. doi: 10.1371/journal.pntd.0009854. eCollection 2022 Mar.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mario A Rojas, MD, MPH principal investigator
Professor of Pediatrics
Luz A Gutierrez, MD study director
Universidad Industrial de Santander
Luis A Diaz, MD, MSc study chair
Universidad Industrial de Santander
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Microcephaly and Mental Retardation, run by Universidad Industrial de Santander at 1 site in Colombia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Colombia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurodevelopmental Outcome (time frame: 24 months corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02943304, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2023.