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Clinical Trials/NCT00661791
NCT00661791CompletedNot Applicable

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

George Washington University2 sites in 1 country60 target enrollmentStarted: February 2003Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
2
Primary Endpoint
Average daily weight gain. Length of hospital stay
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
28 Weeks to 32 Weeks (Child)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Average daily weight gain. Length of hospital stay

Time Frame: From birth until time of hospital discharge

Secondary Outcomes

  • Effect on heart rate and respirations(Birth until time of hospital discharge)

Investigators

Sponsor Class
Other

Study Sites (2)

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Effects of Massage Therapy and Kinesthetic... | Clinical Trial