Premature Birth of Newborn
Conditions
Keywords
infant, premature, message, therapy, NICU, neonatal intensive care unit, cortisol level, stress, postnatal, weight gain, DMT, Development Message Therapy, growth
Brief summary
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.
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.
Interventions
OTHERDevelopmental Massage Therapy
Tactile stimulation and massage will be done by a licensed therapist
OTHERno intervention
The infant will not be touched by the therapist.
Sponsors
National Institutes of Health (NIH)
University of Utah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
No minimum to 14 Days
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Growth | Weekly |
Secondary
| Measure | Time frame |
|---|---|
| Salivary cortisol levels | Daily for first week; Weekly thereafter |
| Neurobehavioral Assessment | Weekly, Term, 3 months, 6 months |
Countries
United States
Outcome results
None listed