Effects of Massage on the Immune System of Preterm Infants

NCT00317278 | Completed Phase 1 DMC

• 1 other identifier: R21AT001872-01A2
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Premature Birth; Stress

Keywords

Massage; immune system; preterm infants

Outcome Measures

Primary Outcomes (1)

• NK cell numbers

  baseline, midway and end of study

Secondary Outcomes (1)

• Cellular immune function

  baseline, midway and end of study

Study Arms (2)

A,1

EXPERIMENTAL

Massage therapy

Other: massage therapy

A,2

SHAM COMPARATOR

Other: Sham

Interventions

massage therapy OTHER

massage therapy to stable preterm infants

A,1

Sham OTHER

Sham (placebo) provided to the control group

A,2

Eligibility Criteria

• Age: 28 Weeks - 33 Weeks
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Medically stable premature infants

You may not qualify if:

• Unstable premature infants with underlying medical condition

Sponsors & Collaborators

• National Center for Complementary and Integrative Health (NCCIH): lead

Study Sites (1)

Detroit Medical Center/Wayne State University

Detroit, Michigan, 48201, United States

Location

MeSH Terms

Conditions

Premature Birth

Interventions

Massage; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Officials

• Jocelyn Y. Ang, MD

  Wayne State University/Detroit Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: April 20, 2006
• First Posted: April 24, 2006
• Study Start: October 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: July 1, 2009
• Last Updated: December 7, 2009

Record last verified: 2009-12

Locations

US (1)