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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Utah
ClinicalTrials.gov Identifier:
NCT00722943
First received: July 24, 2008
Last updated: February 6, 2013
Last verified: February 2013
  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 Blind (Subject, Caregiver)
Primary Purpose: Basic Science
Official Title: Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

Resource links provided by NLM:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Growth [ Time Frame: Weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Salivary cortisol levels [ Time Frame: Daily for first week; Weekly thereafter ] [ Designated as safety issue: No ]
  • Neurobehavioral Assessment [ Time Frame: Weekly, Term, 3 months, 6 months ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   up to 14 Days
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00722943

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

No publications provided by University of Utah

Additional 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
Study First Received: July 24, 2008
Last Updated: February 6, 2013
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on April 21, 2014