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Effects of Massage on the Immune System of Preterm Infants

NCT00317278 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2009-12-07

No results posted yet for this study

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.

Conditions

  • Premature Birth
  • Stress

Interventions

OTHER

massage therapy

massage therapy to stable preterm infants

OTHER

Sham

Sham (placebo) provided to the control group

Sponsors & Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

    lead NIH

Principal Investigators

  • Jocelyn Y. Ang, MD · Wayne State University/Detroit Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
28 Weeks
Max Age
33 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-10-31
Primary Completion
2009-02-28
Completion
2009-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00317278 on ClinicalTrials.gov