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Effects of Massage on the Immune System of Preterm Infants

Primary Purpose

Premature Birth, Stress

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
massage therapy
Sham
Sponsored by
National Center for Complementary and Integrative Health (NCCIH)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Premature Birth focused on measuring Massage, immune system, preterm infants

Eligibility Criteria

28 Weeks - 33 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Detroit Medical Center/Wayne State University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

A,1

A,2

Arm Description

Massage therapy

Outcomes

Primary Outcome Measures

NK cell numbers

Secondary Outcome Measures

Cellular immune function

Full Information

First Posted
April 20, 2006
Last Updated
December 4, 2009
Sponsor
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00317278
Brief Title
Effects of Massage on the Immune System of Preterm Infants
Official Title
Effects of Massage on Immune System of Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Already contained in Brief Summary

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth, Stress
Keywords
Massage, immune system, preterm infants

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A,1
Arm Type
Experimental
Arm Description
Massage therapy
Arm Title
A,2
Arm Type
Sham Comparator
Intervention Type
Other
Intervention Name(s)
massage therapy
Intervention Description
massage therapy to stable preterm infants
Intervention Type
Other
Intervention Name(s)
Sham
Intervention Description
Sham (placebo) provided to the control group
Primary Outcome Measure Information:
Title
NK cell numbers
Time Frame
baseline, midway and end of study
Secondary Outcome Measure Information:
Title
Cellular immune function
Time Frame
baseline, midway and end of study

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
33 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Medically stable premature infants Exclusion Criteria: Unstable premature infants with underlying medical condition
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jocelyn Y. Ang, MD
Organizational Affiliation
Wayne State University/Detroit Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Detroit Medical Center/Wayne State University
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States

12. IPD Sharing Statement

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Effects of Massage on the Immune System of Preterm Infants

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