Effects of Neonatal Therapeutic Touch and Massage in Very Preterm and Extremely Preterm Neonates: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Length of stay
研究概览
简要总结
The goal of this clinical trial is to learn about the effects of Neonatal Touch and Massage Therapy on premature babies.
The main questions it aims to answer are:
- Do babies who receive Neonatal Touch and Massage Therapy get discharged sooner from the NICU
- Does Neonatal Touch and Massage Therapy have a beneficial effect on weight gain, pain and stress responses, and neurodevelopmental outcomes.
Participants assigned to the treatment group will receive Neonatal Touch and Massage Therapy while admitted to the NICU. Researchers will compare their outcomes to a control group, receiving standard NICU care, to see if there are any differences in the length of hospital stay, weight gain, pain scores, neurodevelopmental outcomes, and incidence of other common conditions associated with prematurity.
详细描述
The purpose of this study is to determine the effects of Neonatal Touch and Massage Therapy on premature infants in the NICU. Babies enrolled in this study will be randomly assigned to receive Neonatal Touch and Massage or standard NICU care. Babies in the therapy group will be given Neonatal Touch or Massage therapy by certified providers 3 days per week for 5 to 15 minutes. Therapy will be done for a minimum of 4 weeks. The investigators will assess pain and stress responses before and after treatment. The investigators will also review participant's medical records to collect information about weight gain, length of hospitalization, and general health status. After a participant is discharged home, information will be collected about participant's developmental assessments at regularly scheduled NICU follow-up clinic appointments. There are no significant risks with this therapy. Potential benefits of therapy include increased weight gain, shorter hospitalization, decreased pain and stress, and improved developmental outcomes. Information gained from this study could also help future babies.
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
- Single (Outcomes Assessor)
盲法说明
Assessors evaluating neurodevelopmental outcomes will be masked from knowing which intervention was assigned to individual participants.
入排标准
- 年龄范围
- 24 Weeks 至 32 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Infants born or admitted to University of Maryland NICU in the first 14 days of life
- •Gestational age greater than 23 6/7 weeks and less than 32 weeks at birth
- •Deemed medically stable by the medical care team
排除标准
- •Life limiting conditions, including genetic syndromes
- •Cyanotic heart disease
- •Requiring major surgery or critically ill at time of intervention
- •Osteopenia of prematurity with an existing fracture
研究组 & 干预措施
Intervention
This group will receive structured neonatal touch or massage therapy from a certified NICU provider. Therapy will given 3 days a week for 5 to 15 minutes for a minimum of 4 weeks. We will also be collecting data to assess pain and stress responses during the period immediately before, during, and shortly after the therapy. This includes assessment of crying/irritability, behavior state, facial expression, extremities tone, and vital signs (heart rate, breathing rate, and oxygen levels).
干预措施: Neonatal Touch and Massage Therapy (Other)
Control
This group will receive standard NICU care, no different than if they were not enrolled in the study.
结局指标
主要结局
Length of stay
时间窗: Day of birth to discharge home, up to 6 months
Total length of hospitalization, from NICU admission to discharge home in days
次要结局
- Linear growth(Through study intervention, an average of 4 weeks)
- Weight gain(Through study intervention, an average of 4 weeks)
- Head growth(Through study intervention, an average of 4 weeks)
- Neurodevelopmental Outcomes(Within in 1 week of NICU discharge or transfer until up to 3 years of age)
- Pain scores(1 hour before intervention and up to 3 hours post-intervention)
研究者
Johana Diaz
Assistant professor of pediatrics, Division of neonatology, University of Maryland
University of Maryland, Baltimore