Zika Virus Infection Clinical Trial
Official title:
Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
Verified date | September 2018 |
Source | University of Sao Paulo |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
Introduction: It is estimated that more than one million Brazilians were infected by zika virus in the last two years. Brazilian researchers first noted the virus's potential association with microcephaly. Objective: This study aimed to describe the motor performance of children aged between 6-18 months with the diagnoses of congenital Zika syndrome. Method: This is a cross-sectional, prospective and descriptive study. The study population consisted of 31 children. Participants were evaluated using Alberta Infant Motor Scale (AIMS) and Gross Motor Function Measure (GMFM).
Status | Completed |
Enrollment | 31 |
Est. completion date | April 16, 2017 |
Est. primary completion date | September 15, 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 18 Months |
Eligibility |
Inclusion Criteria: - birth weight between 2,000 and 4,000 g, - gestational age between 35 and 42 weeks, - zika maternal infection (confirmed by blood or urine exam) in the first or second gestation trimesters and having head circumference below 33 cm at birth. Exclusion Criteria: - Other diseases or injuries at birth such as Traumatic brain injury, - Parenchymal hemorrhage, - Hypoxic Ischemic Encephalopathy (HIE), - Obstetric brachial palsy. |
Country | Name | City | State |
---|---|---|---|
Brazil | School of Arts, Sciences and Humanities of the University of Sao Paulo | Sao Paulo | São Paulo |
Lead Sponsor | Collaborator |
---|---|
University of Sao Paulo |
Brazil,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Children with microcephaly at birth, whose mothers had zika virus infection in the first or second gestation trimester, showed poor sensorimotor outcomes, mainly impaired muscle tone and antigravity postural control. | Sensorimotor outcomes was assessed by using Alberta Infant Motor Scale (AIMS) | 1 month | |
Secondary | Children whose mothers were affected in the first trimester had lower head circumference measures that children whose mothers were affected in the second trimester. | Assessment of birth head circumference. | 1 month |
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