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

This study has been completed.
Sponsor:
Information provided by:
George Washington University
ClinicalTrials.gov Identifier:
NCT00661791
First received: April 15, 2008
Last updated: April 17, 2008
Last verified: April 2008
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Massage Therapy and Kinesthetic Stimulation on Pre-Term Infants

Resource links provided by NLM:


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
No Intervention: A
Control Group receives routine care.
Experimental: B.
massage group, receives massage only.
Behavioral: Massage therapy without exercise
Infants will receive massage twice a day; 15 minutes each.
Experimental: C.
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

No publications provided

Responsible Party: Hany Z. Aly, MD, George Washington University Medical Center
ClinicalTrials.gov Identifier: NCT00661791     History of Changes
Other Study ID Numbers: IRB120206
Study First Received: April 15, 2008
Last Updated: April 17, 2008
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

ClinicalTrials.gov processed this record on November 27, 2014