Effects of Massage on the Immune System of Preterm Infants

Stress Clinical Trial

Official title:

Effects of Massage on Immune System of Preterm Infants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00317278
• Other study ID #: R21AT001872-01A2
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: April 20, 2006
• Last updated: December 4, 2009
• Start date: October 2005
• Est. completion date: July 2009

Study information

• Verified date: December 2009
• Source: National Center for Complementary and Integrative Health (NCCIH)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Description:

Already contained in Brief Summary

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 33 Weeks

Eligibility

Inclusion Criteria:

• Medically stable premature infants

Exclusion Criteria:

• Unstable premature infants with underlying medical condition

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Premature Birth
• Stress

Intervention

Other:
• massage therapy
massage therapy to stable preterm infants
• Sham
Sham (placebo) provided to the control group

Locations

Country	Name	City	State
United States	Detroit Medical Center/Wayne State University	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NK cell numbers		baseline, midway and end of study	No
Secondary	Cellular immune function		baseline, midway and end of study	No