Detroit Medical Center/Wayne State University
Detroit, Michigan, 48201, United States
NCT Number: NCT00317278
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.
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Notify Me28 week–33 week
All sexes
Interventional
Phase 1 / Phase 2
Detroit, Michigan, 48201, United States
Already contained in Brief Summary
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
massage therapy to stable preterm infants
Sham (placebo) provided to the control group
Time frame: baseline, midway and end of study
Time frame: baseline, midway and end of study
National Center for Complementary and Integrative Health (NCCIH)
Nih
Effects of Massage on Immune System of Preterm Infants
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