Follow Ups of Parents With Infants With Cleft Lip and Palate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 1
- 主要终点
- Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
研究概览
简要总结
In Norway, 100-120 children are born with CLP (1.9 per 1,000 live births) each year. Parents of infants with CLP need information and support, especially with feeding immediately after birth. These needs are often not met. The purpose of this study is to investigate the effect of systematic follow ups of parents with infants with CLP performed by a special trained nurse. Parental information needs, parental coping and stress and infant growth and feeding will be explored and compared to a control group receiving standard care. 26 parents (mothers and fathers) or more shall be included in each group according to specific criteria. The control should be examined first. Both groups will answer questionnaires 3 times during the child's first year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Parents of infants with cleft lip and palate (CLP); cleft lip, cleft palate or cleft lip and palate
- •Birthplace in south-east region of Norway
- •Scandinavian speaking parents
排除标准
- •Parents of infants with CLP who are referred to the hospital after the first measure point
- •Birthplace outside south-east region of Norway
- •Non-scandinavian speaking parents
结局指标
主要结局
Infant growth as measured by "Demographic data Questionnaire" and "Child health card"
时间窗: 1 month post partum
Both groups
Parental stress as measured by Parenting Stress Index (PSI), Perceived Stress Scale (PSS)
时间窗: 13 months post partum
Both groups
Quality of discharge teaching as measured by Quality of Discharge Teaching Scale (QDTS)-Parent form
时间窗: 1 month post partum
Both groups
Parental coping as measured by Post-Discharge Coping Difficulty Scale (PDCDS)
时间窗: 1 month post partum
Both Groups
Infant feeding as measured by Survey of infant diets and "Feeding Questionnaire" (study specific questionnaire)
时间窗: 13 months post partum
Both groups
Infant growth as measured by "Child health card"
时间窗: 13 months post partum
Both groups
Parental views on the follow up as measured by "Response on the follow up" (study specific questionaire)
时间窗: 6 months post partum
Both groups
次要结局
未报告次要终点
研究者
Kim Alexander Tønseth
Head of Department of Plastic and Reconstructive Surgery
Oslo University Hospital