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

April 17, 2008 updated by: George Washington University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 months to 7 months (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Average daily weight gain. Length of hospital stay
Time Frame: From birth until time of hospital discharge
From birth until time of hospital discharge

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect on heart rate and respirations
Time Frame: Birth until time of hospital discharge
Birth until time of hospital discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George Washington University

Investigators

  • Principal Investigator: Hany Z Aly, MD, George Washington University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2003

Primary Completion (Actual)

April 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

April 15, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 18, 2008

Study Record Updates

Last Update Posted (Estimate)

April 18, 2008

Last Update Submitted That Met QC Criteria

April 17, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB120206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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