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Effects of Massage on the Immune System of Preterm Infants

This study has been completed.
Sponsor:
Information provided by:
National Center for Complementary and Alternative Medicine (NCCAM)
ClinicalTrials.gov Identifier:
NCT00317278
First received: April 20, 2006
Last updated: December 4, 2009
Last verified: December 2009
  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

Further study details as provided by National Center for Complementary and Alternative Medicine (NCCAM):

Primary Outcome Measures:
  • NK cell numbers [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Criteria

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 ClinicalTrials.gov identifier: NCT00317278

Locations
United States, Michigan
Detroit Medical Center/Wayne State University
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Investigators
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 Complications
Obstetric Labor, Premature
Pregnancy Complications

ClinicalTrials.gov processed this record on November 27, 2014