跳至主要内容
临床试验/NCT03381027
NCT03381027已完成不适用

BABY SMART (Study of Massage Therapy, Sleep And neurodevelopMenT)

University College Cork1 个研究点 分布在 1 个国家目标入组 408 人开始时间: 2017年6月5日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
408
试验地点
1
主要终点
Infant sleep measured by video EEG length of sleep cycles

研究概览

简要总结

It is well known that sleep is essential for brain development and learning. Infants require extensive sleep for development of the hippocampus, pons, brainstem, and midbrain and for optimizing physical growth. It is also essential for brain plasticity; the genetically determined ability of the infant brain to change its structure and function in response to the environment. Studies in young animals have shown that sleep deprivation leads to increased programmed cell death, smaller brain size, and loss of brain plasticity, all of which have negative long-term impact on behaviour and learning ability.

Infant massage, a form of systematic tactile stimulation by human hands, improves sleep hygiene. Very little is known about how massage influences early brain development but it is certainly linked to the theory of environmental enrichment, which has been well established in animal models.

The aim of this project is to optimise the infant's sensory experience through a multi-sensory enrichment programme, including massage (a massage utilising a scented lotion before sleep each day), to encourage more structured sleep and ultimately show improved developmental and cognitive outcomes.

详细描述

See study protocol attached.

研究设计

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

盲法说明

Neurodevelopmental assessors are blinded to interventional arm.

入排标准

年龄范围
37 Weeks 至 42 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Infants born > 37 weeks gestation
  • Single births
  • Not requiring admission to the Neonatal Unit
  • Healthy infants without suspected congenital or metabolic anomalies

排除标准

  • Infants born < 37 weeks gestation
  • Multiple births
  • Severe metabolic or genetic anomaly that would require ongoing specialist care in the infancy period.

结局指标

主要结局

Infant sleep measured by video EEG length of sleep cycles

时间窗: assessment carried out in fourth month of life

Sleep EEG

次要结局

  • Neuro-development measured by Griffiths 3 Developmental Assessment(Assessment carried out at 4 & 18 month of life)

研究者

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

Professor Geraldine Boylan

Professor Geraldine Boylan INFANT Centre Director

University College Cork

研究点 (1)

Loading locations...

相似试验

BABY SMART (Study of Massage Therapy, Sleep And... | 临床试验