- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03679728
Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Method This was a cross-sectional, prospective and descriptive study. This study was approved by the Ethics Committee for Analysis of Research Projects of the University of São Paulo - School of Arts, Sciences and Humanities - EACH, under the protocol number approved CAAE: 65822017.3.0000.5390. Parents or caregivers gave written informed consent prior to participating. Children were evaluated by Physiotherapists who had at least two years of neuropediatric practice in the cities of Arcoverde and Recife in Pernambuco, Brazil.
Sample Participants were evaluated in Salud Serviços de Reabilitação Clinic (Recife) and Mens Sana Clinic (Arcoverde) using Alberta Infant Motor Scale (AIMS - prone, supine, sitting, standing, total score and corresponding percentile) and Gross Motor Function Measure (GMFM, A: lying/rolling and B: sitting). Head circumference at birth and on the day of assessment (in cm), age (in months) and family income, as well as AIMS and GMFM scores, provided as means, standard deviations, and minimum and maximum scores. Qualitative data about sex, muscle tone (increased, decreased or normal), visual/ hearing impairments (yes or no) were also collected.
Assessment Scales To assess performance of the children the following motor scales and assessments were used.
- Alberta Infant Motor Scale (AIMS) is a reliable and easy-to-use clinical assessment tool for the evaluation of infant gross motor development from birth until the acquisition of independent walking. AIMS is a norm-referenced measure of infant gross motor development. It contains 58 items, which assess the control and integrity of the antigravity muscles during observation of infant motor skills in prone, supine, sitting, and standing positions. It has been recognized as a useful tool to assess gross motor maturation during infancy, to trace motor delay, and to identify infants who may benefit from early intervention Supine, prone, sitting, standing scores and the total score were registered, as well as the age corresponding percentiles. Interpretation of an AIMS score is never made at the level of individual items, rather it is derived from percentile ranking established through plotting an infant's age to the closest week and his or her total score on the centile graph, the percentile rankings provided on the centile graph would be unaffected for all infants because all age differences are less than one week.
- The Gross Motor Function Measure (GMFM) is a clinical tool designed to evaluate the change in gross motor function in children with disabilities. This measure consists of 88 items that evaluate lying and rolling up to walking, running and jumping skills. There is a four-point scoring system for each item on the GMFM and can be used with children above 6 months. In the present study, only dimensions A (lying and rolling) and B (sitting) were used. Item scores can be summed to calculate raw and percentile scores for each of the GMFM dimensions, selected goal areas and a total score.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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São Paulo
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Sao Paulo, São Paulo, Brazil, 03828000
- School of Arts, Sciences and Humanities of the University of Sao Paulo
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
First trimester
Group of children from mother affected by Zika virus in the first trimester of pregnancy.
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Analysis of sensorimotor outcomes
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Second trimester
Group of Children from mother affected by Zika virus in the second trimester of pregnancy.
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Analysis of sensorimotor outcomes
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
Time Frame: 1 month
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Sensorimotor outcomes was assessed by using Alberta Infant Motor Scale (AIMS)
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1 month
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Children whose mothers were affected in the first trimester had lower head circumference measures that children whose mothers were affected in the second trimester.
Time Frame: 1 month
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Assessment of birth head circumference.
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1 month
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Carlos BM Monteiro, PhD, University of São Paulo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 65822017.3.0000.5390
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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