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

NCT ID: NCT00661791

Last Updated: 2008-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2007-10-31

Brief Summary

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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

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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.

Conditions

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Prematurity

Keywords

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preterm infants massage physical activity weight gain length of hospital stay NICU

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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A

Control Group receives routine care.

Group Type NO_INTERVENTION

No interventions assigned to this group

B.

massage group, receives massage only.

Group Type EXPERIMENTAL

Massage therapy without exercise

Intervention Type BEHAVIORAL

Infants will receive massage twice a day; 15 minutes each.

C.

Massage and Exercise group, receives both massage and exercise.

Group Type EXPERIMENTAL

Massage therapy with exercise

Intervention Type BEHAVIORAL

Infants will receive massage with exercise twice a day; 15 minutes each.

Interventions

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Massage therapy without exercise

Infants will receive massage twice a day; 15 minutes each.

Intervention Type BEHAVIORAL

Massage therapy with exercise

Infants will receive massage with exercise twice a day; 15 minutes each.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

28 Weeks

Maximum Eligible Age

32 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George Washington University

OTHER

Sponsor Role lead

Responsible Party

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George Washington University Medical Center

Principal Investigators

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Hany Z Aly, MD

Role: PRINCIPAL_INVESTIGATOR

George Washington University

Locations

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George Washington University Hospital

Washington D.C., District of Columbia, United States

Site Status

Countries

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United States

Other Identifiers

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IRB120206

Identifier Type: -

Identifier Source: org_study_id