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临床试验/NCT03392727
NCT03392727已完成不适用

Evaluation of Safe Sleep for Babies: a Bassinet Distribution and Education Program

University of Manitoba1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年1月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Usual sleep position

研究概览

简要总结

This study will evaluate baby box ownership and safe sleep practices (sleep location, sleep position, use of bedding) among families provided a free baby box and standardized safe sleep education compared to families provided a safe sleep pamphlet and information on how to obtain a free box in the community.

详细描述

The proposed study is a randomized controlled trial with two arms: the intervention group (n=110) will be provided a baby box and standardized face to face education regarding the box and its contents, safe sleep, and infant health promotion; the control group (n=110) will be provided information on how to obtain the same baby box at a community site in Winnipeg, and will receive a safe sleep pamphlet, baby box pamphlet and a guide to online resources for prenatal ad infant health promotion. An additional comparison group will be parents who already have a baby box at the time of recruitment. This group will also receive the safe sleep pamphlet. Families will be interviewed at recruitment and 2-4 months of age to measure box ownership and self-reported safe sleep and infant health promotion practices. Administrative data will be used to evaluate the impact on infant immunizations and hospitalizations in the first year of life, and to evaluate the impacts of prenatal care visits and neonatal length of stay on the outcomes.

Families will be asked to participate in a face to face interview at baseline (enrolment) and one follow-up interview coordinated with a scheduled routine healthcare visit for the infant at 2 months of age and conducted face to face or by telephone, according to family preference.

PHIN will be requested for both mother and infant in order to explore the relationship between adequacy of prenatal care and the study outcomes, and to evaluate the impact on infant immunizations and hospitalizations in the first year of life. Postal code will be requested to analyze differences related to place of residence and neighbourhood income quintile.

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
None

入排标准

年龄范围
— 至 2 Months(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Mothers who are 32 weeks or more gestation
  • •Infants less than 3 months of age (or post-conceptional age 44 weeks)
  • •Able to consent freely and complete face to face and/or telephone interviews in English
  • •Will be residing in Winnipeg until the infant is 2-4 months of age or able to complete a telephone interview at 2-4 months of age

排除标准

  • •Parent/guardian/client less than 18 years of age (unless emancipated minor)
  • •Parents who cannot consent due to intellectual capacity, medical condition, etc.
  • •Infant is discharged from hospital in the care of Child and Family Services or a birth alert is in place

研究组 & 干预措施

Study Box & Education Session

Experimental

Parents are provided a baby box and infant health and safety products and participate in a face to face educational session

干预措施: Study Box (Device)

Study Box & Education Session

Experimental

Parents are provided a baby box and infant health and safety products and participate in a face to face educational session

干预措施: Education Session (Behavioral)

Community Box & Online Education

Active Comparator

Parents are informed how to receive a free box from a community site and are provided a guide to online resources for prenatal and infant health promotion

干预措施: Community Box (Device)

Community Box & Online Education

Active Comparator

Parents are informed how to receive a free box from a community site and are provided a guide to online resources for prenatal and infant health promotion

干预措施: Online Education (Behavioral)

结局指标

主要结局

Usual sleep position

时间窗: 2 months

supine, other

Usual sleep location

时间窗: 2 months

crib, cradle, bassinet, box, other

Baby box use for sleep

时间窗: 2 months

always/sometimes/never/not applicable

Box ownership

时间窗: 2 months

Parents with a baby box

Usual infant clothing for sleep

时间窗: 2 months

sleeper, sack, swaddled

Usual bedding

时间窗: 2 months

none, tucked blanket, other

次要结局

  • Infant hospitalizations(12 months)
  • Current infant feeding(2 months)
  • Safe sleep knowledge(2 months)
  • Vitamin D(2 months)
  • Prenatal visits(9 months)
  • Household smoking(2 months)
  • Immunizations(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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