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临床试验/NCT04362098
NCT04362098Unknown不适用

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 Paulo2 个研究点 分布在 1 个国家目标入组 167 人开始时间: 2018年6月13日最近更新:
适应症

试验速览

阶段
不适用
入组人数
167
试验地点
2
主要终点
Change in Neuropsychomotor Development During First Year of Life: Receptive Language

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
14 Years 至 20 Years(Child, Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

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

结局指标

主要结局

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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: 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

时间窗: From 3 to 12 months of age

Child assessment with the Bayley Scale of Infant Development

次要结局

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

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guilherme Vanoni Polanczyk, MD PhD

Professor

University of Sao Paulo

研究点 (2)

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