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

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00661791
• Other study ID #: IRB120206
• Status: Completed
• Phase: N/A
• First received: April 15, 2008
• Last updated: April 17, 2008
• Start date: February 2003
• Est. completion date: October 2007

Study information

• Verified date: April 2008
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2007
• Est. primary completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 32 Weeks

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prematurity

Intervention

Behavioral:
• Massage therapy without exercise
Infants will receive massage twice a day; 15 minutes each.
• Massage therapy with exercise
Infants will receive massage with exercise twice a day; 15 minutes each.

Locations

Country	Name	City	State
United States	George Washington University Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
George Washington University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily weight gain. Length of hospital stay		From birth until time of hospital discharge	No
Secondary	Effect on heart rate and respirations		Birth until time of hospital discharge	No