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Clinical Trials/NCT04362098
NCT04362098
Unknown
N/A

The Effects Over Early Brain Development of a Nurse Home Visitation Program for Pregnant Youth and Their Families Living in a Poor Urban Area in São Paulo, Brazil II

University of Sao Paulo1 site in 1 country167 target enrollmentJune 13, 2018

Overview

Phase
N/A
Intervention
Not specified
Conditions
Child Development
Sponsor
University of Sao Paulo
Enrollment
167
Locations
1
Primary Endpoint
Change in Neuropsychomotor Development During First Year of Life: Receptive Language
Last Updated
6 years ago

Overview

Brief Summary

Home visiting programs for pregnant women aiming to improve mother-infant relationship has received worldwide attention in the past 30 years. These programs are considered an important strategy to improve women's health during pregnancy, aside from improving child's birthing conditions and allowing parents access to tools which will nurture and properly stimulate their baby, thus promoting emotional and cognitive development. Objectives: The "Nurse home visitation program for pregnant youth" aims to promote infant´s healthy development, from pregnancy to the first months of life, in a high-risk population. Methods: Eighty young pregnant women aged between 14 and 21 years were randomly allocated to the intervention or to usual prenatal care program. The "Nurse home visitation program for pregnant youth" was developed based on Albert Bandura's theory of self-efficacy, on Urie Bronfenbrenner´s bioecological model, which recognizes the importance of individual and family inclusion in various contexts of social life, on John Bowlby and Mary Ainsworth evolutionary theories of attachment, which involves the care practitioner addressing issues such as environmental health, life course and parenting, bond between mother and infant, and infant´s social and cognitive development. Neuropsychomotor development will be assessed at 3, 6, 12 and 24 months using the Bayley Scale of Infant Development. Brain development will be assessed via electroencephalography at 6, 12 and 24 months.

Registry
clinicaltrials.gov
Start Date
June 13, 2018
End Date
June 2022
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Guilherme Vanoni Polanczyk, MD PhD

Professor

University of Sao Paulo

Eligibility Criteria

Inclusion Criteria

  • Low socioeconomic status
  • Mother's age between 14-19
  • Mother being a primapara
  • Gestation between the 8th and 16th week

Exclusion Criteria

  • High-risk gestation
  • Mother's Intellectual, visual or auditory disability

Outcomes

Primary Outcomes

Change in Neuropsychomotor Development During First Year of Life: Receptive Language

Time Frame: From 3 to 12 months of age

Child assessment with the Bayley Scale of Infant Development.

Change in Neuropsychomotor Development During First Year of Life: Expressive Language

Time Frame: From 3 to 12 months of age

Child assessment with the Bayley Scale of Infant Development

Change in Neuropsychomotor Development During First Year of Life: Fine Motor

Time Frame: From 3 to 12 months of age

Child assessment with the Bayley Scale of Infant Development, fine motor scale.

Change in Neuropsychomotor Development During First Year of Life: Cognition

Time Frame: From 3 to 12 months of age

Complete child assessment with the Bayley Scale of Infant Development at 3, 6 and 12 months of age.

Change in Neuropsychomotor Development During First Year of Life: Gross Motor

Time Frame: From 3 to 12 months of age

Child assessment with the Bayley Scale of Infant Development

Secondary Outcomes

  • Change in Child Brain Maturation(At 6 and 12 months)
  • Mother-child Attachment Biomarker(At 6 and 12 months)

Study Sites (1)

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