Preterm Infants' Weight Gain Following Massage Therapy

Premature Birth Clinical Trial

Official title:

Preterm Infants' Weight Gain Following Massage Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00029198
• Other study ID #: R01AT000370-01
• Secondary ID: R01AT000370-01R0
• Status: Completed
• Phase: Phase 3
• First received: January 9, 2002
• Last updated: April 9, 2014
• Start date: April 2003
• Est. completion date: March 2008

Study information

• Verified date: April 2014
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

The specific aims of this study are: 1) to replicate the data that following ten days of massage therapy, preterm infants show greater daily weight gain and are discharged from the hospital earlier than the controls, thus demonstrating the cost-effectiveness of the intervention; 2) to test a model on two potential underlying mechanisms for weight gain including a) enhanced vagal activity leading to greater gastric motility, higher levels of insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control infants at the end of the study; and/or b) increased physical activity and its associated increase in heart rate oxygen consumption and temperature leading to greater weight gain. These pathways (vagal activity and physical activity) will be tested by path analyses. Determining underlying mechanisms for the massage therapy/weight gain relationship is a critical process required by the neonatology community for massage therapy to be adopted as a standard neonatal intensive care unit.

Description:

A number of studies have documented an average of 47% greater weight gain in preterm neonates following massage therapy. Our currently funded study suggests that massage therapy increases vagal activity, oxytocin, and IGF-1. In the proposed continuation of this study preemies would be provided daily massages three times a day for 10 days, as in our previously successful protocol. To determine potential mechanisms that may underlie the massage therapy/weight gain relationship we will continue to assess vagal activity and assay insulin, oxytocin, IGF-1 and cortisol as well as gastric motility. We have added an alternative potential pathway for the massage therapy/weight gain relationship. In this expanded model, activity level and the related measures of heart rate, oxygen consumption (based on a formula calculated from heart rate) and temperature mediate the effects of massage therapy on weight gain. A larger sample will be recruited so that we can have the power needed to test our model of the potential mechanisms underlying the weight gain from preterm infant massage. For the current application, 120 preterm infants with common medical complications of prematurity, who are medically stable and residing in the intermediate care ("grower") nursery, will be assigned to groups based on a random stratification on the following variables: gender, gestational age, birthweight, days in the NICU, and study entry weight. One hundred twenty infants will be randomly assigned to one of two groups: 1) ten days of massage therapy (n=60), or 2) standard treatment (n=60). Within-subjects and between-groups analyses will focus on physiological (heart rate, vagal tone, gastric motility, and temperature), biochemical (insulin, oxytocin, IGF-1 and cortisol) and behavioral variables (activity level).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: March 2008
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 28 Weeks to 32 Weeks

Eligibility

Inclusion Criteria:

• Gestational age between 28 and 32 weeks

• Birthweight between 800 and 1,400 grams

• Birthweight, length, and head circumference appropriate for gestational age

• Scores on the Obstetric/Postnatal Complications scales are each below 80

• NICU stay between 15 and 60 days

• Current weight between 1,000 and 1,500 grams

• Current daily intake is between 120 and 160 calories

Exclusion Criteria:

• Genetic anomalies, congenital heart malformations, and/or central nervous system dysfunction

• HIV infection

• History of maternal alcohol or illicit drug use

• Syphilis

• Hepatitis B

• Require surgery

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Premature Birth
• Weight Gain

Intervention

Procedure:
• massage
15 massage given tid
• Sham massage
non-massage touch

Locations

Country	Name	City	State
United States	University of Miami School of Medicine	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight gain		post-massage	No

External Links

•   Touch Research Institutes