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Sponsored by: |
George Washington University |
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Information provided by: | George Washington University |
ClinicalTrials.gov Identifier: | NCT00661791 |
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.
Condition | Intervention |
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Prematurity |
Behavioral: Massage therapy without exercise Behavioral: Massage therapy with exercise |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Efficacy Study |
Official Title: | Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants |
Enrollment: | 60 |
Study Start Date: | February 2003 |
Study Completion Date: | October 2007 |
Primary Completion Date: | April 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: No Intervention
Control Group receives routine care.
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B.: Experimental
massage group, receives massage only.
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Behavioral: Massage therapy without exercise
Infants will receive massage twice a day; 15 minutes each.
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C.: Experimental
Massage and Exercise group, receives both massage and exercise.
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Behavioral: Massage therapy with exercise
Infants will receive massage with exercise twice a day; 15 minutes each.
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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.
Ages Eligible for Study: | 28 Weeks to 32 Weeks |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, District of Columbia | |
George Washington University Hospital | |
Washington, District of Columbia, United States, 20037 |
Principal Investigator: | Hany Z Aly, MD | George Washington University |
Responsible Party: | George Washington University Medical Center ( Hany Z. Aly, MD ) |
Study ID Numbers: | IRB120206 |
Study First Received: | April 15, 2008 |
Last Updated: | April 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00661791 |
Health Authority: | United States: Institutional Review Board |
preterm infants massage physical activity |
weight gain length of hospital stay NICU |
Body Weight Weight Gain |