Preterm Infants' Weight Gain Following Massage Therapy
Condition: Premature Birth
MeSH terms: Premature Birth; Weight Gain
Study type: Interventional
Phase: Phase 3

Summary: 
      The specific aims of this study are: 1) to replicate the data that following ten days of
      massage therapy, preterm infants show greater daily weight gain and are discharged from the
      hospital earlier than the controls, thus demonstrating the cost-effectiveness of the
      intervention; 2) to test a model on two potential underlying mechanisms for weight gain
      including a) enhanced vagal activity leading to greater gastric motility, higher levels of
      insulin, IGF-1, and oxytocin and lower cortisol levels in the massage versus the control
      infants at the end of the study; and/or b) increased physical activity and its associated
      increase in heart rate oxygen consumption and temperature leading to greater weight gain.
      These pathways (vagal activity and physical activity) will be tested by path analyses.
      Determining underlying mechanisms for the massage therapy/weight gain relationship is a
      critical process required by the neonatology community for massage therapy to be adopted as a
      standard neonatal intensive care unit.
    

Detailed description: 
      A number of studies have documented an average of 47% greater weight gain in preterm neonates
      following massage therapy. Our currently funded study suggests that massage therapy increases
      vagal activity, oxytocin, and IGF-1. In the proposed continuation of this study preemies
      would be provided daily massages three times a day for 10 days, as in our previously
      successful protocol. To determine potential mechanisms that may underlie the massage
      therapy/weight gain relationship we will continue to assess vagal activity and assay insulin,
      oxytocin, IGF-1 and cortisol as well as gastric motility. We have added an alternative
      potential pathway for the massage therapy/weight gain relationship. In this expanded model,
      activity level and the related measures of heart rate, oxygen consumption (based on a formula
      calculated from heart rate) and temperature mediate the effects of massage therapy on weight
      gain. A larger sample will be recruited so that we can have the power needed to test our
      model of the potential mechanisms underlying the weight gain from preterm infant massage. For
      the current application, 120 preterm infants with common medical complications of
      prematurity, who are medically stable and residing in the intermediate care ("grower")
      nursery, will be assigned to groups based on a random stratification on the following
      variables: gender, gestational age, birthweight, days in the NICU, and study entry weight.
      One hundred twenty infants will be randomly assigned to one of two groups: 1) ten days of
      massage therapy (n=60), or 2) standard treatment (n=60). Within-subjects and between-groups
      analyses will focus on physiological (heart rate, vagal tone, gastric motility, and
      temperature), biochemical (insulin, oxytocin, IGF-1 and cortisol) and behavioral variables
      (activity level).
    

Intervention name(s): massage; Sham massage
Intervention type(s): Procedure; Procedure
Intervention description(s): 15 massage given tid; non-massage touch
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Massage Therapy; Preterm Infants; Weight Gain; Vagal Tone; IGF-1; Oxytocin; Brazelton