Effects of Massage on the Immune System of Preterm Infants

Study Overview
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Brief Summary
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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.

Detailed Description
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Already contained in Brief Summary

Official Title
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Effects of Massage on Immune System of Preterm Infants

Conditions
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Premature Birth, Stress

Intervention / Treatment
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* Other: massage therapy
* Other: Sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Medically stable premature infants Exclusion Criteria: Unstable premature infants with underlying medical condition

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 33 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A,1<br>Massage therapy | Other: massage therapy<br>* massage therapy to stable preterm infants<br>|
| Sham Comparator: A,2<br> | Other: Sham<br>* Sham (placebo) provided to the control group<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NK cell numbers |  | baseline, midway and end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cellular immune function |  | baseline, midway and end of study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Massage, immune system, preterm infants