Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study
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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 |
- Growth [ Time Frame: Weekly ] [ Designated as safety issue: No ]
- 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 |
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| 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 | |
| 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 May 22, 2013