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Sponsored by: |
National Center for Complementary and Alternative Medicine (NCCAM) |
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Information provided by: | National Center for Complementary and Alternative Medicine (NCCAM) |
ClinicalTrials.gov Identifier: | 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.
Condition | Intervention | Phase |
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Premature Birth Stress |
Other: massage therapy Other: Sham |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment |
Official Title: | Effects of Massage on Immune System of Preterm Infants |
Estimated Enrollment: | 120 |
Study Start Date: | October 2005 |
Estimated Study Completion Date: | August 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A,1: Experimental
Massage therapy
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Other: massage therapy
massage therapy to stable preterm infants
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A,2: Sham Comparator |
Other: Sham
Sham (placebo) provided to the control group
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Already contained in Brief Summary
Ages Eligible for Study: | 28 Weeks to 33 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jocelyn Y. Ang, MD | 313-745-5863 | jang@med.wayne.edu |
United States, Michigan | |
Detroit Medical Center/Wayne State University | Recruiting |
Detroit, Michigan, United States, 48201 |
Principal Investigator: | Jocelyn Y. Ang, MD | Wayne State University/Detroit Medical Center |
Responsible Party: | WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION ( Michael A Anderson ) |
Study ID Numbers: | R21 AT001872-01A2 |
Study First Received: | April 20, 2006 |
Last Updated: | March 27, 2009 |
ClinicalTrials.gov Identifier: | NCT00317278 History of Changes |
Health Authority: | United States: Federal Government |
Massage immune system preterm infants |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Stress Premature Birth |
Pregnancy Complications Obstetric Labor, Premature Obstetric Labor Complications Premature Birth |