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Effects of Massage on the Immune System of Preterm Infants

NCT ID: NCT00317278

Last Updated: 2009-12-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2009-07-31

Brief Summary

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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

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Already contained in Brief Summary

Conditions

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Premature Birth Stress

Keywords

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Massage immune system preterm infants

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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A,1

Massage therapy

Group Type EXPERIMENTAL

massage therapy

Intervention Type OTHER

massage therapy to stable preterm infants

A,2

Group Type SHAM_COMPARATOR

Sham

Intervention Type OTHER

Sham (placebo) provided to the control group

Interventions

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massage therapy

massage therapy to stable preterm infants

Intervention Type OTHER

Sham

Sham (placebo) provided to the control group

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Medically stable premature infants

Exclusion Criteria

* Unstable premature infants with underlying medical condition
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

33 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role lead

Responsible Party

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WAYNE STATE UNIVERSITY/SPONSORED PROGRAM ADMINISTRATION

Principal Investigators

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Jocelyn Y. Ang, MD

Role: PRINCIPAL_INVESTIGATOR

Wayne State University/Detroit Medical Center

Locations

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Detroit Medical Center/Wayne State University

Detroit, Michigan, United States

Site Status

Countries

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United States

Other Identifiers

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R21AT001872-01A2

Identifier Type: NIH

Identifier Source: org_study_id

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