Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study (DMT)
|ClinicalTrials.gov Identifier: NCT00722943|
Recruitment Status : Completed
First Posted : July 28, 2008
Last Update Posted : February 8, 2013
|Condition or disease||Intervention/treatment||Phase|
|Premature Birth of Newborn||Other: Developmental Massage Therapy Other: no intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|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|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
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.
- Growth [ Time Frame: Weekly ]
- Salivary cortisol levels [ Time Frame: Daily for first week; Weekly thereafter ]
- Neurobehavioral Assessment [ Time Frame: Weekly, Term, 3 months, 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00722943
|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|
|Principal Investigator:||Laurie J Moyer-Mileur, PhD||University of Utah|