ZikaNCT04118738

International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy

An observational study of Zika and Neurodevelopmental Abnormality, run by Westat at 5 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 42 monthsHealthy volunteers can take part
Conditions the study is for: Zika, Neurodevelopmental Abnormality, Hearing Loss
How many people: 272 participants
Where: 5 sitesin 4 countries
Study dates: 12 Jun 2019to 15 Apr 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 18 to 42 months
All sexes
Healthy volunteers accepted
Child

Study population: Approximately 200 children with confirmed or presumptive in-utero exposure to Zika virus and approximately 200 children matched by site and birth sex without confirmed or presumptive in-utero exposed to Zika virus.

Who may be able to join

ZIKV- Exposed Inclusion Criteria:
Parent(s)/legal guardian(s) provided written permission for his or her child to participate.
Participant and/or participant's biological mother previously enrolled in the ZIP study or other ZIKV cohort study approved by the sponsors.
Participant's biological mother has laboratory documentation of positive ZIKV RNA test results during pregnancy through delivery delivery or the participant has laboratory documentation of ZIKV RNA or serology positive/presumptive positive/equivocal ZIKV test within 5 days of birth according to the ZIKV-exposed definitions included in the ZIP 2.0 inclusion criteria.
Minimum 74 weeks of age (approximately 17months) of age at enrollment
ZIKV-Unexposed Inclusion Criteria:

Show all 11Show fewer

Parent(s)/legal guardian(s) provided written permission for his or her child to participate.
Previously enrolled in the ZIP study and identified as matching the same birth sex and followed at the same study site as an enrolled ZIKV-exposed participant.
Laboratory documentation that the participant's biological mother has negative ZIKV RNA test results and no positive ZIKV RNA test results at any time during her pregnancy through delivery.
Participant did not test ZIKV RNA and/or serology positive presumptive positive or equivocal at any time prior to ZIP 2.0 enrollment, if testing was performed prior to enrollment.
Minimum 74 weeks of age (approximately 17months) of age at enrollment

Who cannot join

Enrolled in other clinical research (including other ZIKV research) requiring blood collection, which in combination with ZIP 2.0 evaluations, would exceed the lesser of 50 mL or 3 mL per kg in an 8-week period and/or blood collection would be required more frequently than two times per week.

Trial locations and contacts

5 sites in 4 countries.

Country

City, postcode or hospital

5 sites in 4 countries

Brazil2 sites

Departamento de Medicina Tropical da Universidade Federal de Pernambuco- UFPE
Recife, Pernambuco, 50670-901
Instituto Fernandes Figueira - FIOCRUZ
Rio de Janeiro, 22250-020

Other trials in Brazil

Colombia1 site

Centro Médico Imbanaco (CMI)
Cali, 760031

Other trials in Colombia

Peru1 site

Asociación Civil Selva Amazónica
Iquitos, Loreto, 16001

Other trials in Peru

Puerto Rico1 site

Puerto Rico Medical Center- Maternal Infant Studies Center (CEMI)
San Juan, 00936

Other trials in Puerto Rico

About this study

Official title: The International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy

The International Cohort Study of Children Born to Women Infected with Zika Virus (ZIKV) During Pregnancy study is a prospective, observational, international cohort study of children previously enrolled in the ZIP study or other ZIP 2.0 Protocol Team approved ZIKV-cohort study that will continue the longitudinal follow-up of children born with documented confirmed or presumptive in-utero ZIKV exposure ("ZIKV-exposed" cohort) and children born without documented confirmed or presumptive in-utero ZIKV exposure, matched by site and birth sex ("ZIKV-unexposed" cohort).

Follow-up evaluations and assessments will allow for the determination and comparison of long-term neurodevelopmental outcomes among in utero ZIKV-exposed and ZIKV-unexposed children. Each participant will be followed for about 2 years, beginning at approximately 18 months through 42 months of age.

Read the detailed description

The International Prospective Observational Cohort Study of Zika in Infants and Pregnancy (ZIP) study has leveraged 10 international sites to follow mother-infant dyads prospectively in pregnancy and postpartum to determine the incidence and outcomes of Zika Virus (ZIKV) infection. The ZIP study has collected demographic, physical, environmental, laboratory, and delivery outcome data in relation to mother-infant pairs with and without ZIKV infection. Infants born to women enrolled in the ZIP study are followed for 1 year and undergo regular physical and neurological assessments to identify clinical or developmental outcomes.

The International Cohort Study of Children Born to Women Infected with Zika Virus During Pregnancy (ZIP 2.0) study will enroll children who themselves or whose biological mothers were previously enrolled in the ZIP study and other ZIP 2.0 Protocol Team-approved studies. Assessments include growth, neurodevelopmental, audiologic, ophthalmologic, and other clinical outcomes. Evaluations will occur about every 6 months over about a 2-year period beginning at approximately 18 months of age. Follow-up evaluations and assessments will allow for the determination and comparison of long-term neurodevelopmental outcomes among in utero ZIKV-exposed and ZIKV-unexposed children.

After parent(s)/legal guardian(s) permission is obtained for the child's participation in ZIP 2.0, several means to contact them will be requested. Parents will be asked whether or not messages can be left for each of the phone numbers provided and if messages can contain information regarding the nature of the study.

We expect to compare approximately 200 children with documented confirmed or presumptive in-utero ZIKV exposure and 200 controls matched by site and birth sex without documented confirmed or presumptive in-utero ZIKV exposure at age approximately 18 months, and at age 42 months.

The primary objective is to determine the long-term neurodevelopmental outcomes among children born with documented confirmed or presumptive in-utero ZIKV exposure. The secondary objectives are to compare the long-term effects (e.g., on growth, vision, hearing and neurodevelopment) of in-utero ZIKV-exposure compared to unexposed children.

Conditions: Zika, Neurodevelopmental Abnormality, Hearing Loss, Growth Delay, Eye Abnormalities
Keywords: ZIKA
Medical subject headings: Zika Virus Infection, Hearing Loss, Eye Abnormalities

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04118738
Study group	Role	What they receive
ZIKV-Exposed		Children born to women with documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery or the children's laboratory documentation of confirmed or presumptive in-utero ZIKV exposure within five days of birth.
ZIKV-Unexposed		Children born to women without documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery and the children have no laboratory documentation of confirmed or presumptive in-utero ZIKV exposure at any time prior to ZIP 2.0 enrollment, if testing was performed prior to enrollment.

What is being measured

The primary outcome is the main question the study is designed to answer.

Neurodevelopmental outcome at age18 months
Neurodevelopment will be measured at age 18 months (entry visit) with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III). The scores indicates how well the child performed compared to a group of children within the same age range.
Measured: At enrollment
Neurodevelopmental outcome at age 24 months
Neurodevelopment will be measured at age 24 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Measured: Six months after enrollment
Neurodevelopmental outcome at age 30 months
Neurodevelopment will be measured at age 30 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Measured: Twelve months after enrollment
Neurodevelopmental outcome at age 36 months
Neurodevelopment will be measured at age 36 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Measured: Eighteen months after enrollment.
Neurodevelopmental outcome at age 42 months
Neurodevelopment will be measured at age 42 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Measured: Twenty four months after enrollment

Secondary outcomes (28)

Anthropometric Measurements: Height
Height in centimeters will be measured at age 18 months (entry visit).
Measured: At enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 24 months
Measured: Six months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 30 months
Measured: Twelve months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 36 months
Measured: Eighteen months after enrollment
Anthropometric Measurements: Height
Height in centimeters will be measured at age 42 months
Measured: Twenty-four months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 18 months (entry visit).
Measured: At enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 24 months (entry visit).
Measured: Six months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 30 months (entry visit).
Measured: Twelve months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 36 months (entry visit).
Measured: Eighteen months after enrollment
Anthropometric Measurements: Weight
Weight in kilograms will be measured at age 42 months (entry visit).
Measured: Twenty-four months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 18 months (entry visit).
Measured: At enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 24 months.
Measured: Six months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 30 months.
Measured: Twelve months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 36 months.
Measured: Eighteen months after enrollment
Anthropometric Measurements: Head circumference
Head circumference in centimeters will be measured at age 42 months.
Measured: Twenty-four months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 24 months
Measured: Six months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 18 months
Measured: At enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 30 months
Measured: Twelve months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 36 months
Measured: Eighteen months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Mid upper arm circumference in centimeters will be measured at age 42 months
Measured: Twenty-four months after enrollment
Hearing assessment: A-verage (in dB HL) of the value of Air-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).Audiometry (VRA)
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Average (in dB HL) of Bone-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Proportion of children in different categories of the degree of hearing loss
Proportion of children in different categories of the degree of hearing loss (Normal hearing; Mild hearing loss; Moderate hearing loss; Severe hearing loss; and Profound hearing loss). The degree of hearing loss will be determined by grouping the average of the value of Air-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children in different categories of the type of hearing loss
Proportion of children in different categories of the type of hearing loss (Sensorineural hearing loss; Conductive hearing loss; and Mixed hearing loss). The type of hearing loss will be established by comparing the mean of air-conduction levels.
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children with abnormal results in the Otoacustic Emissions test.
Measured: Time Frame: At enrollment only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment, and 18 months after enrollment.
Comprehensive ophthalmologic evaluation.
General examination of eye structure and assessment of visual function. Composite measure of Visual function based on visual behaviors (with minimum and maximum possible values of -6 and +6, respectively).
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Comprehensive ophthalmologic evaluation
Composite measure of Retina evaluation (with minimum and maximum possible values of -14 and +14, respectively).
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4)
Comprehensive ophthalmologic evaluation
Composite measure of Optic Nerve evaluation (with minimum and maximum possible values of -12 and +12, respectively
Measured: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Jun 201915 Apr 2022

First posted8 Oct 2019
Study start12 Jun 2019
Primary completion15 Apr 2022
Study completion15 Apr 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for ZikaStudies 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: 272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04118738
Sponsor's protocol ID: ZIP 2.0
Status last verified: Apr 2022
First submitted: 1 Jul 2019
Last updated: 22 Apr 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Zika trials

Study at a glance

From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The International Cohort Study of Children Born to Women Infected With Zika Virus During Pregnancy
ClinicalTrials.gov ID: NCT04118738
Acronym / sponsor ID: ZIP 2.0
Conditions: Zika, Neurodevelopmental Abnormality, Hearing Loss, Growth Delay, Eye Abnormalities
Keywords: ZIKA
Study type: Observational
Recruitment status: Completed
Enrolment: 272 participants (actual)
Lead sponsor: WestatUniversity, hospital or other
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), National Institute of Allergy and Infectious Diseases (NIAID), Oswaldo Cruz Foundation
Study start: 12 Jun 2019 (actual)
Primary completion: 15 Apr 2022 (actual)
Study completion: 15 Apr 2022 (actual)
First posted: 8 Oct 2019 (actual)
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.

Detailed description

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
ZIKV-Exposed	–	–Children born to women with documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery or the children's laboratory documentation of confirmed or presumptive in-utero ZIKV exposure within five days of birth.
ZIKV-Unexposed	–	–Children born to women without documented confirmed or presumptive in-utero ZIKV exposure during pregnancy through delivery and the children have no laboratory documentation of confirmed or presumptive in-utero ZIKV exposure at any time prior to ZIP 2.0 enrollment, if testing was performed prior to enrollment.

Who may qualify

Ages: 18 to 42 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child
Study population: Approximately 200 children with confirmed or presumptive in-utero exposure to Zika virus and approximately 200 children matched by site and birth sex without confirmed or presumptive in-utero exposed to Zika virus.

Key inclusion criteria (11 listed)

Parent(s)/legal guardian(s) provided written permission for his or her child to participate.
Participant and/or participant's biological mother previously enrolled in the ZIP study or other ZIKV cohort study approved by the sponsors.
Participant's biological mother has laboratory documentation of positive ZIKV RNA test results during pregnancy through delivery delivery or the participant has laboratory documentation of ZIKV RNA or serology positive/presumptive positive/equivocal ZIKV test within 5 days of birth according to the ZIKV-exposed definitions included in the ZIP 2.0 inclusion criteria.
Minimum 74 weeks of age (approximately 17months) of age at enrollment
Parent(s)/legal guardian(s) provided written permission for his or her child to participate.

Key exclusion criteria (1 listed)

Enrolled in other clinical research (including other ZIKV research) requiring blood collection, which in combination with ZIP 2.0 evaluations, would exceed the lesser of 50 mL or 3 mL per kg in an 8-week period and/or blood collection would be required more frequently than two times per week.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Neurodevelopmental outcome at age18 months
Time frame: At enrollment
Neurodevelopment will be measured at age 18 months (entry visit) with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III). The scores indicates how well the child performed compared to a group of children within the same age range.
Neurodevelopmental outcome at age 24 months
Time frame: Six months after enrollment
Neurodevelopment will be measured at age 24 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Neurodevelopmental outcome at age 30 months
Time frame: Twelve months after enrollment
Neurodevelopment will be measured at age 30 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Neurodevelopmental outcome at age 36 months
Time frame: Eighteen months after enrollment.
Neurodevelopment will be measured at age 36 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).
Neurodevelopmental outcome at age 42 months
Time frame: Twenty four months after enrollment
Neurodevelopment will be measured at age 42 months with the Bayley Scales of Infant and Toddler Development, 3rd Edition (BSID-III).

28 secondary outcomes

Anthropometric Measurements: Height
Time frame: At enrollment
Anthropometric Measurements: Height
Time frame: Six months after enrollment
Anthropometric Measurements: Height
Time frame: Twelve months after enrollment
Anthropometric Measurements: Height
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Height
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Weight
Time frame: At enrollment
Anthropometric Measurements: Weight
Time frame: Six months after enrollment
Anthropometric Measurements: Weight
Time frame: Twelve months after enrollment
Anthropometric Measurements: Weight
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Weight
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Head circumference
Time frame: At enrollment
Anthropometric Measurements: Head circumference
Time frame: Six months after enrollment
Anthropometric Measurements: Head circumference
Time frame: Twelve months after enrollment
Anthropometric Measurements: Head circumference
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Head circumference
Time frame: Twenty-four months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Time frame: Six months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Time frame: At enrollment
Anthropometric Measurements: Mid upper arm circumference
Time frame: Twelve months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Time frame: Eighteen months after enrollment
Anthropometric Measurements: Mid upper arm circumference
Time frame: Twenty-four months after enrollment
Hearing assessment: A-verage (in dB HL) of the value of Air-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).Audiometry (VRA)
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Average (in dB HL) of Bone-conduction test obtained for all frequencies measured (500Hz, 1000 Hz, 2000Hz and 4000Hz).
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Hearing assessment: Proportion of children in different categories of the degree of hearing loss
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children in different categories of the type of hearing loss
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]
Hearing assessment: Proportion of children with abnormal results in the Otoacustic Emissions test.
Time frame: Time Frame: At enrollment only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment, and 18 months after enrollment.
Comprehensive ophthalmologic evaluation.
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).
Comprehensive ophthalmologic evaluation
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4)
Comprehensive ophthalmologic evaluation
Time frame: At enrollment (visit 1) only if the participant missed the evaluation(s) at the 12-month ZIP study visit or is 95 or greater weeks of age at the Entry visit; then, six months after enrollment (visit 2), and 18 months after enrollment (visit 4).]

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 22 Apr 2022.
Individual participant dataSharing planned: Undecided

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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.

Deolinda MF Scalabrin, MD, PhD study chair

Research Center- FIOCRUZ Brazil

Marisa M. Mussi-Pinhata, MD, MD study chair

Ribeirão Preto Medical School- University of Sao Paulo

Maria Elisabeth L Moreira, MD study chair

Instituto Fernandes Figueira - FIOCRUZ

5 sites in 4 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Zika and Neurodevelopmental Abnormality, run by Westat at 5 sites in 4 countries.

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 11 inclusion and 1 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 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil, Colombia, Peru, Puerto Rico. 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 at age18 months (time frame: At enrollment). The study lists 5 primary outcomes in all. 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 NCT04118738.

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 22 Apr 2022.