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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00722943
First Posted: July 28, 2008
Last Update Posted: February 8, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institutes of Health (NIH)
Information provided by (Responsible Party):
University of Utah
  Purpose
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.

Condition Intervention
Premature Birth of Newborn Other: Developmental Massage Therapy Other: no intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Basic Science
Official Title: Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Growth [ Time Frame: Weekly ]

Secondary Outcome Measures:
  • Salivary cortisol levels [ Time Frame: Daily for first week; Weekly thereafter ]
  • Neurobehavioral Assessment [ Time Frame: Weekly, Term, 3 months, 6 months ]

Enrollment: 46
Study Start Date: July 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: DMT group
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.
Other: Developmental Massage Therapy
Tactile stimulation and massage will be done by a licensed therapist
Placebo Comparator: SHAM control
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.
Other: no intervention
The infant will not be touched by the therapist.

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 14 Days   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722943


Locations
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
St. Mark's Hospital
Salt Lake City, Utah, United States, 84124
University of Utah
Salt Lake City, Utah, United States, 84132
Sponsors and Collaborators
University of Utah
National Institutes of Health (NIH)
Investigators
Principal Investigator: Laurie J Moyer-Mileur, PhD University of Utah
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of Utah
ClinicalTrials.gov Identifier: NCT00722943     History of Changes
Other Study ID Numbers: 28032
First Submitted: July 24, 2008
First Posted: July 28, 2008
Last Update Posted: February 8, 2013
Last Verified: February 2013

Keywords provided by University of Utah:
infant
premature
message
therapy
NICU
neonatal intensive care unit
cortisol level
stress
postnatal
weight gain
DMT
Development Message Therapy
growth

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications


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