Use of a Tummy Time Intervention and Parent Education in Infants Born Preterm: a Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Test of Infant Motor Performance (TIMP) for motor outcome
研究概览
简要总结
The purpose of this research study is to see if tummy time and parent education helps motor development among infants born preterm. Participants will be recruited from Ann and Robert H. Lurie Children's Hospital of Chicago neonatal intensive care unit.
详细描述
The purpose of this randomized control trial will be to investigate the effects of a tummy time intervention, as compared to standard care, on motor outcomes among premature infants over a four-week period. Additionally, the study will measure tummy time adherence rates between groups post intervention for an additional four weeks.
To meet this purpose, the following objectives will be addressed:
- To determine if there will be a difference in motor outcome scores on the Test of Infant Motor Performance (TIMP) among infants born preterm and utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
- To determine if there will be a difference in adherence rates (average minutes/day) between groups among infants born preterm utilizing a tummy time intervention and parent education compared to those in the standard care group receiving parent education only.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
盲法说明
Outcome assessor investigator will be masked to all medical diagnoses of the infant
入排标准
- 年龄范围
- 35 Weeks 至 44 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be eligible to participate in the study, participants must meet the following inclusion criteria:
- •born premature (< 37 weeks' gestation),
- •require medical care within Lurie Children's NICU, be between 35 and 44 weeks postmenstrual age.
- •Primary parent must have a working mobile device.
- •Participants must be English or Spanish speaking as primary language.
- •Exclusion criteria:
- •primary parent does not having a working mobile device and
- •Speaking a language other than English or Spanish.
- •Unable to be placed in the prone position,
- •Physiologically unstable for handling
- •Orally intubated or have a tracheostomy
排除标准
- 未提供
结局指标
主要结局
Test of Infant Motor Performance (TIMP) for motor outcome
时间窗: Change in motor outcome will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.
The TIMP is a functional motor scale for newborns, including those born premature, up to infants four months corrected age, and was specifically designed for use in neonatal intensive care units (Rose \& Westcott, 2005).
次要结局
- PT Pal Application: Adherence(Change in adherence will be measured at initiation and at 8 weeks. Each participant will be enrolled in the study for 8 weeks. The study is expected to be completed within 6 months.)
研究者
Kathryn Martin
Dawn Drumm, PT Physical Therapist
University of Indianapolis