Developmental Outcome of Preterm Infants Enrolled in a Randomized Clinical of a Parent Administered Sensorimotor Intervention in the Neonatal Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Attainment of independent oral feeds
研究概览
简要总结
Advances in medical technologies over the last three decades have increased survival rates in infants born preterm . Preterm infants are at high risk of developing developmental delays. Implementation of effective strategies aimed at improving the developmental outcome of preterm born children is critical.
The proposed study is designed to evaluate the addition of a parent administered sensorimotor program on the developmental outcome of infants who are born preterm.
详细描述
Children who are born prematurely are at a higher risk of developing developmental delays than children born at term. Early experiences in the neonatal intensive care unit (NICU) can influence developmental outcomes. Sensorimotor interventions as well as parental engagement have been designed with the aim of improving the development of children born preterm. Substantial evidence supports the benefits of each intervention on improving developmental outcomes. However, there remains a significant gap in the literature on the efficacy of a parent administered sensorimotor intervention (PASI) program in the NICU on infant's development. The proposed study is designed to evaluate the potential benefits of such a program on infant's development. A randomized block clinical trial will be performed.
A total of 84 preterm infants (< 34 weeks gestation) will be recruited and randomized. Infants in the experimental group will receive the sensorimotor program,consisting of tactile (whole body) and oral input for 15 minutes, one time per day, for 10 days. Infants in the control group will receive standard care. The following outcomes will be monitored time to attainment of complete oral feeds (primary outcome), rate of weight gain, length of hospitalization, and developmental outcomes at 36 weeks corrected gestational age and at 4, 8, 12, 18 and 24 months corrected age. Results from this study will provide us with further knowledge on the impact of sensorimotor intervention on infants' developmental outcome as well as the effect of active parental involvement on infants' development. Provision of a PASI program is a safe and low cost effective intervention that may increase the development and quality of life of preterm born children and their family.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- None
盲法说明
A prospective randomized block clinical trial will be conducted. Infants will be randomized into experimental (PASI program) and control (standard care program) groups using a block size of four per arm, where the first set of four participants will be in the experimental group and once they have completed the intervention, the subsequent set of four participants will be in the control group. A randomized block design was selected because the treatment assignment cannot be masked. The block randomization procedure will reduce the potential for contamination between groups.
入排标准
- 年龄范围
- — 至 34 Weeks(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infants born < 34 weeks gestation
- •Infants whose parent (s) intend on visiting regularly (> 5 days)
排除标准
- •Infants born with a metabolic disorder or congenital abnormality
- •Infants whose parents are unable to participate due to cognitive, physical or social issues.
结局指标
主要结局
Attainment of independent oral feeds
时间窗: 3 years
Number of days to transition from complete tube to complete oral feeds.
次要结局
- Length of hospital stay(3 years)
- Test of infant motor performance(3 years)
- Weight gain(3 years)
- Acute stress of parents(3 years)
研究者
Dr. Sandra Fucile
PI
Queen's University
