- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00029198
Preterm Infants' Weight Gain Following Massage Therapy
April 9, 2014 updated by: Tiffany Field, University of Miami
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed 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).
Study Type
Interventional
Enrollment (Actual)
139
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Miami, Florida, United States, 33136
- University of Miami School of Medicine
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 months to 7 months (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 1
15 minute massage tid
|
15 massage given tid
|
SHAM_COMPARATOR: 2
non-massage touch
|
non-massage touch
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
weight gain
Time Frame: post-massage
|
post-massage
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tiffany M Field, PhD, University of Miami
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2003
Primary Completion (ACTUAL)
March 1, 2008
Study Completion (ACTUAL)
March 1, 2008
Study Registration Dates
First Submitted
January 9, 2002
First Submitted That Met QC Criteria
January 9, 2002
First Posted (ESTIMATE)
January 10, 2002
Study Record Updates
Last Update Posted (ESTIMATE)
April 10, 2014
Last Update Submitted That Met QC Criteria
April 9, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- R01AT000370-01 (NIH)
- R01AT000370 (NIH)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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