Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection

• ClinicalTrials.gov Identifier: NCT03679728
• Recruitment Status: Completed
• First Posted: September 20, 2018
• Last Update Posted: September 20, 2018
• Sponsor: University of Sao Paulo
• Information provided by (Responsible Party): Carlos Bandeira de Mello Monteiro, University of Sao Paulo

Study Description

Brief 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. 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).

Condition or disease	Intervention/treatment
Zika Virus Infection	Behavioral: First trimester; Behavioral: Second trimester

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.

1. 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.
2. 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

• Study Type: Observational
• Actual Enrollment: 31 participants
• Observational Model: Other
• Time Perspective: Cross-Sectional
• Official Title: Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection During the First or Second Trimester of Gestation.
• Actual Study Start Date: August 2, 2016
• Actual Primary Completion Date: September 15, 2016
• Actual Study Completion Date: April 16, 2017

Groups and Cohorts

Group/Cohort	Intervention/treatment
First trimester; Group of children from mother affected by Zika virus in the first trimester of pregnancy.	Behavioral: First trimester; Analysis of sensorimotor outcomes
Second trimester; Group of Children from mother affected by Zika virus in the second trimester of pregnancy.	Behavioral: Second trimester; Analysis of sensorimotor outcomes

Outcome Measures

Primary Outcome Measures :

1. 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)

Secondary Outcome Measures :

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. [ Time Frame: 1 month ]
   Assessment of birth head circumference.

Eligibility Criteria

• Ages Eligible for Study: 6 Months to 18 Months (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of 31 children from mother affected with Zika Virus, in Arcoverde and Recife in Pernambuco, Brazil.

Criteria

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.

Contacts and Locations

Locations

Brazil

School of Arts, Sciences and Humanities of the University of Sao Paulo

Sao Paulo, São Paulo, Brazil, 03828000

Sponsors and Collaborators

University of Sao Paulo

Investigators

• Principal Investigator: Carlos BM Monteiro, PhD; University of Sao Paulo

More Information

• Responsible Party: Carlos Bandeira de Mello Monteiro, Associate Professor, University of Sao Paulo
• ClinicalTrials.gov Identifier: NCT03679728
• Other Study ID Numbers: 65822017.3.0000.5390
• First Posted: September 20, 2018
• Last Update Posted: September 20, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Carlos Bandeira de Mello Monteiro, University of Sao Paulo:

Zika virus; Children; Microcephaly

Additional relevant MeSH terms:

Infection; Communicable Diseases; Zika Virus Infection; Virus Diseases; Arbovirus Infections; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections