Effects of Massage on the Immune System of Preterm Infants

National Institutes of Health (NIH)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Stress; Premature Birth

Treatments: Other: Sham; Other: massage therapy

Study type: Interventional

Funder types: NIH

Identifiers

NCT00317278

R21AT001872-01A2

Details and patient eligibility

About

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.

Full description

Already contained in Brief Summary

Enrollment: 120 patients

Sex: All

Ages: 28 to 33 weeks old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Medically stable premature infants

Exclusion criteria

• Unstable premature infants with underlying medical condition

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

A,1

Experimental group

Description:

Massage therapy

Treatment:

Other: massage therapy

A,2

Sham Comparator group

Treatment:

Other: Sham