Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

Not Applicable

Completed

• Conditions: Prematurity
• Interventions: Behavioral: Massage therapy without exercise; Behavioral: Massage therapy with exercise

• Registration Number: NCT00661791
• Lead Sponsor: George Washington University

Brief Summary

The purpose of this study was to determine whether massage with or without physical exercise impacted weight gain or length of hospital stay for premature infants.

Detailed Description

Premature infants are often cared for in a fashion that minimizes physical activity in order to reduce stress and stress-related complications. Previous studies have indicated that massage therapy may increase weight gain and enabled earlier discharge of premature infants.

In this study, premature infants were randomly assigned to one of three groups:

A: Control Group

B: Massage Group, 15 minutes twice a day;

C: Massage and physical exercise group 15 minutes each, twice a day.

Study Timeline

• Study Start: 2003-02
• Primary Completion: 2007-04
• Study Completion: 2007-10
• Status Verified: 2008-04
• Study First Submitted: 2008-04-15
• Study First Submitted QC: 2008-04-17
• Last Update Submitted: 2008-04-17
• Study First Posted: 2008-04-18
• Last Update Posted: 2008-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• low birth weight, less than 1500 grams
• weight of at least 1000 grams at time of entry into study
• must be at least one week of age
• must have relative medical stability
• gestational age between 28-32 weeks

Exclusion Criteria

• infants with major congenital anomaly
• those that require mechanical ventilatory support
• those that are restricted in their movement or ability to undergo the intervention

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B.	Massage therapy without exercise	massage group, receives massage only.
C.	Massage therapy with exercise	Massage and Exercise group, receives both massage and exercise.

Primary Outcome Measures

Name	Time	Method
Average daily weight gain. Length of hospital stay	From birth until time of hospital discharge

Secondary Outcome Measures

Name	Time	Method
Effect on heart rate and respirations	Birth until time of hospital discharge

Trial Locations

Locations (1)

George Washington University Hospital; 🇺🇸 Washington, District of Columbia, United States