Effects of Massage on the Immune System of Preterm Infants
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Purpose
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 |
|---|---|---|
|
Premature Birth Stress |
Other: massage therapy Other: Sham |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Effects of Massage on Immune System of Preterm Infants |
- NK cell numbers [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ]
- Cellular immune function [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ]
| Enrollment: | 120 |
| Study Start Date: | October 2005 |
| Study Completion Date: | July 2009 |
| Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: A,1
Massage therapy
|
Other: massage therapy
massage therapy to stable preterm infants
|
| Sham Comparator: A,2 |
Other: Sham
Sham (placebo) provided to the control group
|
Detailed Description:
Already contained in Brief Summary
Eligibility| Ages Eligible for Study: | 28 Weeks to 33 Weeks |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Medically stable premature infants
Exclusion Criteria:
- Unstable premature infants with underlying medical condition
Contacts and Locations| United States, Michigan | |
| Detroit Medical Center/Wayne State University | |
| Detroit, Michigan, United States, 48201 | |
| Principal Investigator: | Jocelyn Y. Ang, MD | Wayne State University/Detroit Medical Center |
More Information
No publications provided
| Responsible Party: | Michael A Anderson, WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION |
| ClinicalTrials.gov Identifier: | NCT00317278 History of Changes |
| Other Study ID Numbers: | R21 AT001872-01A2 |
| Study First Received: | April 20, 2006 |
| Last Updated: | December 4, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Center for Complementary and Alternative Medicine (NCCAM):
|
Massage immune system preterm infants |
Additional relevant MeSH terms:
|
Premature Birth Obstetric Labor, Premature Obstetric Labor Complications Pregnancy Complications |
ClinicalTrials.gov processed this record on May 16, 2013