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Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study (DMT)

Primary Purpose

Premature Birth of Newborn

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Developmental Massage Therapy
no intervention
Sponsored by
University of Utah
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Premature Birth of Newborn focused on measuring infant, premature, message, therapy, NICU, neonatal intensive care unit, cortisol level, stress, postnatal, weight gain, DMT, Development Message Therapy, growth

Eligibility Criteria

undefined - 14 Days (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Premature infants born between 29 4/7 and 32 3/7 weeks gestation by physical exam at birth, and with birth weight, length and head circumference between the 5th and 95th percentiles for gestational age.

Exclusion Criteria:

  • Intrauterine growth less than the 5th or greater than the 95th percentiles for gestational age, congenital anomalies, complex cardiac defects, severe CNS injury, hypothyroidism, inborn errors of metabolism, or inability to establish full enteral feeds by day of life 14.

Sites / Locations

  • Intermountain Medical Center
  • St. Mark's Hospital
  • University of Utah

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DMT group

SHAM control

Arm Description

These infants will receive tactile stimulation and developmental massage by a licensed therapist. This intervention will be done behind a screen in order to blind the therapy to NICU staff and parents.

These infants will have no tactile stimulation or developmental massage done. The therapist will stand behind a screen but will not touch the infant. The screen will blind the NICU staff and parents to the study arm.

Outcomes

Primary Outcome Measures

Growth

Secondary Outcome Measures

Salivary cortisol levels
Neurobehavioral Assessment

Full Information

First Posted
July 24, 2008
Last Updated
February 6, 2013
Sponsor
University of Utah
Collaborators
National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT00722943
Brief Title
Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study
Acronym
DMT
Official Title
Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Utah
Collaborators
National Institutes of Health (NIH)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to see if daily massage therapy will help premature infants respond to stress better, as well as improve their growth and neurobehavioral development.
Detailed Description
Optimal postnatal growth and development is essential for the survival and long-term health of infants born premature, however, growth and developmental delays are common. Many factors contribute to poor postnatal growth and development including immature organ systems, stress due to illness and even routine care in the neonatal intensive care unit environment. Massage therapy is associated with decreased cortisol levels during stress in a variety of populations including premature infants. Massage has also been reported to improve postnatal weight gain in premature infants. Concerns about methodological quality, however, weaken the credibility of previous studies and prevent the integration of massage therapy into conventional medical practice. Therefore, we plan to study the interrelationship of the ANS and HPA axis in preterm infants to assess how developmental massage therapy (DMT) modulates physiologic stability and promotes postnatal growth by the following specific aims: SPECIFIC AIM 1: We will determine ANS balance, measured by heart period variability, before, during, and after DMT. SPECIFIC AIM 2: We will compare the relationships between ANS balance and HPA response before and after DMT. SPECIFIC AIM 3: We will evaluate somatotrophic response in premature infants who receive DMT. Infants will be stratified by gender and randomized to receive developmental massage therapy or SHAM control. This study will also allow for post-discharge assessment of development. Infants will return to the hospital at term, 3months and 6 months for multiple measurements and developmental testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Premature Birth of Newborn
Keywords
infant, premature, message, therapy, NICU, neonatal intensive care unit, cortisol level, stress, postnatal, weight gain, DMT, Development Message Therapy, growth

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DMT group
Arm Type
Active Comparator
Arm Description
These infants will receive tactile stimulation and developmental massage by a licensed therapist. This intervention will be done behind a screen in order to blind the therapy to NICU staff and parents.
Arm Title
SHAM control
Arm Type
Placebo Comparator
Arm Description
These infants will have no tactile stimulation or developmental massage done. The therapist will stand behind a screen but will not touch the infant. The screen will blind the NICU staff and parents to the study arm.
Intervention Type
Other
Intervention Name(s)
Developmental Massage Therapy
Intervention Description
Tactile stimulation and massage will be done by a licensed therapist
Intervention Type
Other
Intervention Name(s)
no intervention
Intervention Description
The infant will not be touched by the therapist.
Primary Outcome Measure Information:
Title
Growth
Time Frame
Weekly
Secondary Outcome Measure Information:
Title
Salivary cortisol levels
Time Frame
Daily for first week; Weekly thereafter
Title
Neurobehavioral Assessment
Time Frame
Weekly, Term, 3 months, 6 months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
14 Days
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Premature infants born between 29 4/7 and 32 3/7 weeks gestation by physical exam at birth, and with birth weight, length and head circumference between the 5th and 95th percentiles for gestational age. Exclusion Criteria: Intrauterine growth less than the 5th or greater than the 95th percentiles for gestational age, congenital anomalies, complex cardiac defects, severe CNS injury, hypothyroidism, inborn errors of metabolism, or inability to establish full enteral feeds by day of life 14.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurie J Moyer-Mileur, PhD
Organizational Affiliation
University of Utah
Official's Role
Principal Investigator
Facility Information:
Facility Name
Intermountain Medical Center
City
Murray
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
St. Mark's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
23062248
Citation
Moyer-Mileur LJ, Haley S, Slater H, Beachy J, Smith SL. Massage improves growth quality by decreasing body fat deposition in male preterm infants. J Pediatr. 2013 Mar;162(3):490-5. doi: 10.1016/j.jpeds.2012.08.033. Epub 2012 Oct 11.
Results Reference
derived

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Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

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