Premature Birth of Newborn Clinical Trial
— DMTOfficial title:
Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study
Verified date | February 2013 |
Source | University of Utah |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 46 |
Est. completion date | July 2011 |
Est. primary completion date | July 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 14 Days |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Intermountain Medical Center | Murray | Utah |
United States | St. Mark's Hospital | Salt Lake City | Utah |
United States | University of Utah | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
University of Utah | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Growth | Weekly | No | |
Secondary | Salivary cortisol levels | Daily for first week; Weekly thereafter | No | |
Secondary | Neurobehavioral Assessment | Weekly, Term, 3 months, 6 months | No |
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