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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.
Already contained in Brief Summary
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A,1 | Experimental | Massage therapy |
|
| A,2 | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| massage therapy | Other | massage therapy to stable preterm infants |
| |
| Measure | Description | Time Frame |
|---|---|---|
| NK cell numbers | baseline, midway and end of study |
| Measure | Description | Time Frame |
|---|---|---|
| Cellular immune function | baseline, midway and end of study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jocelyn Y. Ang, MD | Wayne State University/Detroit Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Detroit Medical Center/Wayne State University | Detroit | Michigan | 48201 | United States |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D008405 | Massage |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D064746 | Therapy, Soft Tissue |
| D026201 | Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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| Sham |
| Other |
Sham (placebo) provided to the control group |
|
| D000091642 | Urogenital Diseases |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |