NCT00722943

Neuroendocrine Mechanisms of Developmental Massage Therapy (DMT) in Preterm Infants: Clinical Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: University of Utah · Academic / Other
• Sex: All
• Age: 14 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Premature Birth of Newborn

Interventions

Type	Name	Description
OTHER	Developmental Massage Therapy	Tactile stimulation and massage will be done by a licensed therapist
OTHER	no intervention	The infant will not be touched by the therapist.

Timeline

• Start date: 2008-07-01
• Primary completion: 2011-07-01
• Completion: 2011-07-01
• First posted: 2008-07-28
• Last updated: 2013-02-08

Locations

3 sites across 1 country: United States