Effects of Massage on the Immune System of Preterm Infants

Phase 1

Completed

• Conditions: Stress; Premature Birth
• Interventions: Other: massage therapy; Other: Sham

• Registration Number: NCT00317278
• Lead Sponsor: 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.

Detailed Description

Already contained in Brief Summary

Study Timeline

• Study Start: 2005-10
• Study First Submitted: 2006-04-20
• Study First Submitted QC: 2006-04-21
• Study First Posted: 2006-04-24
• Primary Completion: 2009-02
• Study Completion: 2009-07
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-04
• Last Update Posted: 2009-12-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• Medically stable premature infants

Exclusion Criteria

• Unstable premature infants with underlying medical condition

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A,1	massage therapy	Massage therapy
A,2	Sham	-

Primary Outcome Measures

Name	Time	Method
NK cell numbers	baseline, midway and end of study

Secondary Outcome Measures

Name	Time	Method
Cellular immune function	baseline, midway and end of study

Trial Locations

Locations (1)

Detroit Medical Center/Wayne State University; 🇺🇸 Detroit, Michigan, United States