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Effects of Massage on the Immune System of Preterm Infants
This study is ongoing, but not recruiting participants.
Study NCT00317278   Information provided by National Center for Complementary and Alternative Medicine (NCCAM)
First Received: April 20, 2006   Last Updated: July 9, 2009   History of Changes

April 20, 2006
July 9, 2009
October 2005
August 2009   (final data collection date for primary outcome measure)
NK cell numbers [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ]
NK cell numbers
Complete list of historical versions of study NCT00317278 on ClinicalTrials.gov Archive Site
Cellular immune function [ Time Frame: baseline, midway and end of study ] [ Designated as safety issue: No ]
Cellular immune function
 
Effects of Massage on the Immune System of Preterm Infants
Effects of Massage on Immune System of Preterm Infants

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.

Already contained in Brief Summary

Phase I, Phase II
Interventional
Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment
  • Premature Birth
  • Stress
  • Other: massage therapy
  • Other: Sham
Experimental: Massage therapy
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
120
October 2009
August 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Medically stable premature infants

Exclusion Criteria:

  • Unstable premature infants with underlying medical condition
Both
28 Weeks to 33 Weeks
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00317278
Michael A Anderson, WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION
R21 AT001872-01A2
National Center for Complementary and Alternative Medicine (NCCAM)
 
Principal Investigator: Jocelyn Y. Ang, MD Wayne State University/Detroit Medical Center
National Center for Complementary and Alternative Medicine (NCCAM)
July 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP