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临床试验/NCT00317278
NCT00317278已完成1 期

Effects of Massage on Immune System of Preterm Infants

National Center for Complementary and Integrative Health (NCCIH)2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2005年10月最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
120
试验地点
2
主要终点
NK cell numbers

研究概览

简要总结

Infants in the Neonatal Intensive Care Unit (NICU) are exposed to stressful stimuli such as loud noises, bright lights, blood drawing, suctioning, and intubation, and are frequently left in isolation with minimal proper interaction. Stress has been demonstrated to exert a negative effect on the immune system. Different psychological interventions, including relaxation, have been used in efforts to reduce stress, and several of these techniques have been shown to improve cellular immunity. Massage therapy (MT) has been used to reduce stress in premature infants and has been associated with weight gain, shorter hospital stay, and improvement in mental/motor development. While MT has been shown to increase the number and function of natural killer (NK) cells in healthy adults and in adults infected with HIV, the effect of MT on the immune system of children, including premature infants, has never been investigated. The investigators hypothesize that, in premature infants, MT will enhance the immune system. One hundred and twenty stable premature infants meeting selection criteria will be randomized to massage and sham treatment groups. Immunologic evaluation will be performed on both groups at baseline, midway and at the end of therapy. Physicians, nurses, and parents will be masked. The investigators' unique and innovative study will be the largest study in this area and will provide valuable information on potential immune parameters associated with stress reduction and improved development in premature infants undergoing massage therapy.

详细描述

Already contained in Brief Summary

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
28 Weeks 至 33 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Medically stable premature infants

排除标准

  • Unstable premature infants with underlying medical condition

结局指标

主要结局

NK cell numbers

时间窗: baseline, midway and end of study

次要结局

  • Cellular immune function(baseline, midway and end of study)

研究者

研究点 (2)

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