Premature Birth of Newborn Clinical Trial
Official title:
Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study
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.
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.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Basic Science
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