Development and Evaluation of a Parenting Intervention to Promote Development in Infants Born Very Premature
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 试验地点
- 3
- 主要终点
- Difference in Bayley III motor scales scores
研究概览
简要总结
Infants born very premature have biological risk factors for later developmental coordination disorder. Parental stereotyping of infants as fragile and other environmental factors, such as spending long periods laying on their backs, also contribute to motor delay. This study aims to develop and evaluate a computer-based intervention (Helping Our Premature infants ON to better motor skills - HOP-ON) for parents of preterm infants. HOP-ON will model evidence based strategies to develop infants' fine and gross motor skills, and aims to reduce parental stereotyping. It is hypothesised that infants whose parents receive the HOPON CD-ROM/DVD and Booklet will have better motor skills at 12 months adjusted age compared to those whose parents receive a control CD-ROM/DVD and booklet. Parents of infants born at less than 32 weeks gestation (target n = 138) will be recruited prior to discharge from the neonatal unit and randomised to either HOP-ON or control. The primary outcome is motor score (Bayleys III) at 12 months adjusted age. Other outcomes are parental confidence and perceptions of infant capability at 3 months and quality of movement, infant growth, fine and gross motor movement and parenting stress at 12 months. Data will be analysed blind to study condition and on an intention to treat basis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants born less than 32 weeks of gestation, and progressing well enough to have either been recently discharged from hospital, or being discharged from hospital within the next two weeks.
- •Parent/s aged between 16-60 years of age, who have a preterm infant - born less than 32 weeks of gestation.
- •Both parent and infant inclusion criteria must be met for inclusion in the study.
排除标准
- •Parent/s of infants who are still receiving hospital care at 3 months adjusted age, and their premature infants who are still receiving hospital care at 3 months adjusted age.
- •Parent/s of multiple births, where the number of infants is greater than two (three of more infants).
- •To avoid excessive travel costs, infants born outside the defined catchment area will be excluded from the study. There are no other exclusion criteria.
结局指标
主要结局
Difference in Bayley III motor scales scores
时间窗: 12 months corrected age
次要结局
未报告次要终点
