Back to resultsEffects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Primary Purpose
Prematurity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Massage therapy without exercise
Massage therapy with exercise
Sponsored by
About this trial
This is an interventional treatment trial for Prematurity focused on measuring preterm infants, massage, physical activity, weight gain, length of hospital stay, NICU
Eligibility 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
Sites / Locations
- George Washington University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Experimental
Experimental
Arm Label
A
B.
C.
Arm Description
Control Group receives routine care.
massage group, receives massage only.
Massage and Exercise group, receives both massage and exercise.
Outcomes
Primary Outcome Measures
Average daily weight gain. Length of hospital stay
Secondary Outcome Measures
Effect on heart rate and respirations
Full Information
NCT ID
NCT00661791
First Posted
April 15, 2008
Last Updated
April 17, 2008
Sponsor
George Washington University
1. Study Identification
Unique Protocol Identification Number
NCT00661791
Brief Title
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Official Title
Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
Study Type
Interventional
2. Study Status
Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
April 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
George Washington University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity
Keywords
preterm infants, massage, physical activity, weight gain, length of hospital stay, NICU
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
No Intervention
Arm Description
Control Group receives routine care.
Arm Title
B.
Arm Type
Experimental
Arm Description
massage group, receives massage only.
Arm Title
C.
Arm Type
Experimental
Arm Description
Massage and Exercise group, receives both massage and exercise.
Intervention Type
Behavioral
Intervention Name(s)
Massage therapy without exercise
Intervention Description
Infants will receive massage twice a day; 15 minutes each.
Intervention Type
Behavioral
Intervention Name(s)
Massage therapy with exercise
Intervention Description
Infants will receive massage with exercise twice a day; 15 minutes each.
Primary Outcome Measure Information:
Title
Average daily weight gain. Length of hospital stay
Time Frame
From birth until time of hospital discharge
Secondary Outcome Measure Information:
Title
Effect on heart rate and respirations
Time Frame
Birth until time of hospital discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hany Z Aly, MD
Organizational Affiliation
George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
George Washington University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
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Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants
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