Sensorimotor Outcomes of Children Exposed to Foetal Zika Virus Infection

NCT03679728 | Completed

• 1 other identifier: 65822017.3.0000.5390
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Zika Virus Infection

Keywords

Zika virus; Children; Microcephaly

Outcome Measures

Primary Outcomes (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.

  Sensorimotor outcomes was assessed by using Alberta Infant Motor Scale (AIMS)

  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.

  1 month

Study Arms (2)

First trimester

Group of children from mother affected by Zika virus in the first trimester of pregnancy.

Behavioral: First trimester

Second trimester

Group of Children from mother affected by Zika virus in the second trimester of pregnancy.

Behavioral: Second trimester

Interventions

First trimester BEHAVIORAL

Analysis of sensorimotor outcomes

First trimester

Second trimester BEHAVIORAL

Analysis of sensorimotor outcomes

Second trimester

Eligibility Criteria

• Age: 6 Months - 18 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Other diseases or injuries at birth such as Traumatic brain injury,
• Parenchymal hemorrhage,
• Hypoxic Ischemic Encephalopathy (HIE),
• Obstetric brachial palsy.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

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

São Paulo, São Paulo, 03828000, Brazil

Location

MeSH Terms

Conditions

Zika Virus Infection; Microcephaly

Interventions

Pregnancy Trimester, First; Pregnancy Trimester, Second

Condition Hierarchy (Ancestors)

Mosquito-Borne Diseases; Vector Borne Diseases; Infections; Arbovirus Infections; Virus Diseases; Flavivirus Infections; Flaviviridae Infections; RNA Virus Infections; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Musculoskeletal Diseases; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnancy Trimesters; Reproductive Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Study Officials

• Carlos BM Monteiro, PhD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 16, 2018
• First Posted: September 20, 2018
• Study Start: August 2, 2016
• Primary Completion: September 15, 2016
• Study Completion: April 16, 2017
• Last Updated: September 20, 2018

Record last verified: 2018-09

Locations

BR (1)