Zika Virus InfectionNCT03679728
Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection
An observational study of Zika Virus Infection, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 18 months
- Conditions the study is for
- Zika Virus Infection
- What is being tested?
- First trimester and Second trimester
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 31 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Aug 2016to 16 Apr 2017
- 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 6 to 18 months
- All sexes
- No healthy volunteers
- Child
Study population: The study population consisted of 31 children from mother affected with Zika Virus, in Arcoverde and Recife in Pernambuco, Brazil.
Who may be able to join
- 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.
Who cannot join
- Other diseases or injuries at birth such as Traumatic brain injury,
- Parenchymal hemorrhage,
- Hypoxic Ischemic Encephalopathy (HIE),
- Obstetric brachial palsy.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
School of Arts, Sciences and Humanities of the University of Sao Paulo
São Paulo, São Paulo, 03828000
About this study
Official title: Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
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).
Read the 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.
- Conditions
- Zika Virus Infection
- Being tested
- First trimester, Second trimester
- Keywords
- Zika virus, Children, Microcephaly
- Medical subject headings
- Zika Virus Infection, Microcephaly
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First trimesterBehavioural
Analysis of sensorimotor outcomes
Second trimesterBehavioural
Analysis of sensorimotor outcomes
| Study group | Role | What they receive |
|---|---|---|
| First trimester | Group of children from mother affected by Zika virus in the first trimester of pregnancy. Receives: Behavioral: First trimester | |
| Second trimester | Group of Children from mother affected by Zika virus in the second trimester of pregnancy. Receives: Behavioral: Second trimester |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2018
- Study start2 Aug 2016
- Primary completion15 Sep 2016
- Study completion16 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Zika Virus InfectionStudies of the same condition, open and under way.
- More trials run by University of Sao PauloThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlos Bandeira de Mello Monteiro, University of Sao Paulo
- Investigators
- Carlos BM Monteiro, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03679728
- Sponsor's protocol ID
- 65822017.3.0000.5390
- Status last verified
- Sep 2018
- First submitted
- 16 Sep 2018
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
- ClinicalTrials.gov ID
- NCT03679728
- Acronym / sponsor ID
- 65822017.3.0000.5390
- Conditions
- Zika Virus Infection
- Keywords
- Zika virus, Children, Microcephaly
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 15 Sep 2016 (actual)
- Study completion
- 16 Apr 2017 (actual)
- First posted
- 20 Sep 2018 (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.
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).
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 design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First trimester | – | Behavioral: First trimesterGroup of children from mother affected by Zika virus in the first trimester of pregnancy. |
| Second trimester | – | Behavioral: Second trimesterGroup of Children from mother affected by Zika virus in the second trimester of pregnancy. |
Who may qualify
- Ages
- 6 to 18 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consisted of 31 children from mother affected with Zika Virus, in Arcoverde and Recife in Pernambuco, Brazil.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- Other diseases or injuries at birth such as Traumatic brain injury,
- Parenchymal hemorrhage,
- Hypoxic Ischemic Encephalopathy (HIE),
- Obstetric brachial palsy.
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 |
|---|---|---|
| First trimesterAnalysis of sensorimotor outcomes | Behavioural | First trimester |
| Second trimesterAnalysis of sensorimotor outcomes | Behavioural | Second trimester |
Primary outcome
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
Sensorimotor outcomes was assessed by using Alberta Infant Motor Scale (AIMS)
1 secondary outcome
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
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 20 Sep 2018.
- 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.
Carlos BM Monteiro, PhD principal investigator
University of Sao Paulo
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 Zika Virus Infection, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 4 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 20 Sep 2018. 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 Brazil. 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?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Sep 2018.