Effects of Massage on the Immune System of Preterm Infants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00317278
Recruitment Status : Completed
First Posted : April 24, 2006
Last Update Posted : December 7, 2009
Information provided by:
National Center for Complementary and Integrative Health (NCCIH)

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.

Condition or disease Intervention/treatment Phase
Premature Birth Stress Other: massage therapy Other: Sham Phase 1 Phase 2

Detailed Description:
Already contained in Brief Summary

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Massage on Immune System of Preterm Infants
Study Start Date : October 2005
Primary Completion Date : February 2009
Study Completion Date : July 2009

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. NK cell numbers [ Time Frame: baseline, midway and end of study ]

Secondary Outcome Measures :
  1. Cellular immune function [ Time Frame: baseline, midway and end of study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   28 Weeks to 33 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Medically stable premature infants

Exclusion Criteria:

  • Unstable premature infants with underlying medical condition

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00317278

United States, Michigan
Detroit Medical Center/Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Principal Investigator: Jocelyn Y. Ang, MD Wayne State University/Detroit Medical Center

Responsible Party: Michael A Anderson, WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION Identifier: NCT00317278     History of Changes
Other Study ID Numbers: R21AT001872-01A2 ( U.S. NIH Grant/Contract )
First Posted: April 24, 2006    Key Record Dates
Last Update Posted: December 7, 2009
Last Verified: December 2009

Keywords provided by National Center for Complementary and Integrative Health (NCCIH):
immune system
preterm infants

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications