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Preterm Infants' Weight Gain Following Massage Therapy

Primary Purpose

Premature Birth

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
massage
Sham massage
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Premature Birth focused on measuring Massage Therapy, Preterm Infants, Weight Gain, Vagal Tone, IGF-1, Oxytocin, Brazelton

Eligibility Criteria

28 Weeks - 32 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

15 minute massage tid

non-massage touch

Outcomes

Primary Outcome Measures

weight gain

Secondary Outcome Measures

Full Information

First Posted
January 9, 2002
Last Updated
April 9, 2014
Sponsor
University of Miami
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00029198
Brief Title
Preterm Infants' Weight Gain Following Massage Therapy
Official Title
Preterm Infants' Weight Gain Following Massage Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
April 2003 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
March 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
National Center for Complementary and Integrative Health (NCCIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth
Keywords
Massage Therapy, Preterm Infants, Weight Gain, Vagal Tone, IGF-1, Oxytocin, Brazelton

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
Participant
Allocation
Randomized
Enrollment
139 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
15 minute massage tid
Arm Title
2
Arm Type
Sham Comparator
Arm Description
non-massage touch
Intervention Type
Procedure
Intervention Name(s)
massage
Intervention Description
15 massage given tid
Intervention Type
Procedure
Intervention Name(s)
Sham massage
Intervention Description
non-massage touch
Primary Outcome Measure Information:
Title
weight gain
Time Frame
post-massage

10. Eligibility

Sex
All
Minimum Age & Unit of Time
28 Weeks
Maximum Age & Unit of Time
32 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tiffany M Field, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18714203
Citation
Field T, Diego M, Hernandez-Reif M, Dieter JN, Kumar AM, Schanberg S, Kuhn C. Insulin and insulin-like growth factor-1 increased in preterm neonates following massage therapy. J Dev Behav Pediatr. 2008 Dec;29(6):463-6. doi: 10.1097/DBP.0b013e3181856d3b.
Results Reference
derived
Links:
URL
http://www.miami.edu/touch-research
Description
Touch Research Institutes

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Preterm Infants' Weight Gain Following Massage Therapy

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