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Completed

NCT Number: NCT00661791

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

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.

Completed

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Key information

Conditions

Prematurity Behavior Body Weight Body Weight Changes Female Urogenital Diseases and Pregnancy Complications Motor Activity Obstetric Labor Complications Obstetric Labor, Premature Pathological Conditions, Signs and Symptoms Pregnancy Complications Premature Birth Signs and Symptoms Urogenital Diseases Weight Gain

Age range

28 week–32 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

George Washington University Hospital

Washington D.C., District of Columbia, 20037, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Massage therapy without exercise

Behavioral

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

Massage therapy with exercise

Behavioral

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

Primary outcomes

  1. Average daily weight gain. Length of hospital stay

    Time frame: From birth until time of hospital discharge

Secondary outcomes

  1. Effect on heart rate and respirations

    Time frame: Birth until time of hospital discharge

Sponsors and collaborators

Lead sponsor

George Washington University

Other

Registry information

Important dates

Study start
2003
Primary completion
2007
Study completion
2007
First posted
Apr 18, 2008
Registry last updated
Apr 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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