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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 20, 2006 | ||||
| Last Updated Date | July 9, 2009 | ||||
| Start Date ICMJE | October 2005 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
NK cell numbers [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE |
NK cell numbers | ||||
| Change History | Complete list of historical versions of study NCT00317278 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Cellular immune function [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE |
Cellular immune function | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Massage on the Immune System of Preterm Infants | ||||
| Official Title ICMJE | Effects of Massage on Immune System of Preterm Infants | ||||
| Brief Summary | 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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| Detailed Description | Already contained in Brief Summary |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | Experimental: Massage therapy | ||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 120 | ||||
| Estimated Completion Date | October 2009 | ||||
| Estimated Primary Completion Date | August 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 28 Weeks to 33 Weeks | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00317278 | ||||
| Responsible Party | Michael A Anderson, WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION | ||||
| Study ID Numbers ICMJE | R21 AT001872-01A2 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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