This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

Effects of Massage on the Immune System of Preterm Infants

This study has been completed.
Information provided by:
National Center for Complementary and Integrative Health (NCCIH) Identifier:
First received: April 20, 2006
Last updated: December 4, 2009
Last verified: December 2009
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: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effects of Massage on Immune System of Preterm Infants

Further study details as provided by National Center for Complementary and Integrative Health (NCCIH):

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

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

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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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
  More Information

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 )
Study First Received: April 20, 2006
Last Updated: December 4, 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 processed this record on September 21, 2017