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

Sponsored by:	George Washington University
Information provided by:	George Washington University
ClinicalTrials.gov Identifier:	NCT00661791

Purpose

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
Prematurity	Behavioral: Massage therapy without exercise Behavioral: Massage therapy with exercise

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

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

Further study details as provided by George Washington University:

Primary Outcome Measures:

Average daily weight gain. Length of hospital stay [ Time Frame: From birth until time of hospital discharge ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Effect on heart rate and respirations [ Time Frame: Birth until time of hospital discharge ] [ Designated as safety issue: No ]

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
A: No Intervention Control Group receives routine care.
B.: Experimental massage group, receives massage only.	Behavioral: Massage therapy without exercise Infants will receive massage twice a day; 15 minutes each.
C.: Experimental Massage and Exercise group, receives both massage and exercise.	Behavioral: Massage therapy with exercise Infants will receive massage with exercise twice a day; 15 minutes each.

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.

Eligibility

Ages Eligible for Study:	28 Weeks to 32 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00661791

Locations

United States, District of Columbia
George Washington University Hospital
Washington, District of Columbia, United States, 20037

Sponsors and Collaborators

George Washington University

Investigators

Principal Investigator:

Hany Z Aly, MD

George Washington University

More Information

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

Keywords provided by George Washington University:

preterm infants
massage
physical activity

weight gain
length of hospital stay
NICU

Study placed in the following topic categories:

Body Weight
Weight Gain

ClinicalTrials.gov processed this record on January 15, 2009