Effects of Massage Therapy to Induce Sleep in Preterm Infants
Condition: Premature Birth of Newborn
MeSH terms: Premature Birth
Study type: Interventional

Summary: 
      Premature infants sometimes require sedation to ensure minimal movement during diagnostic
      procedures such as MRIs. However, sedatives may produce adverse effects. The purpose of this
      two-day study is to determine whether massage therapy will promote sleep in preterm infants
      and also help them to stay asleep, providing a safer way to sedate infants for procedures. A
      small instrument called a sleep watch or actigraph will be placed around the infant's ankle
      to measure muscle activity and provide an indication of sleep. Infants will receive a 10-
      minute massage on one morning of the study and no massage on the alternate morning.
      Recordings from the actigraph will show whether there is difference in sleep pattern with and
      without massage. Infants will be monitored for any heart rate and oxygen saturation changes
      on both mornings of the study.
    

Detailed description: 
      This cross-over trial pilot study will assess the effectiveness of massage therapy for
      inducing and maintaining sleep in preterm infants. Massage therapy promotes relaxation and
      lowers stress levels, evidenced by increased vagal activity and lower cortisol levels. Safer
      methods of inducing sleep without drugs would be beneficial for infants who require sedation
      for diagnostic studies. The sample will include infants over 3 days old and between 32-40
      weeks adjusted gestational age in a Neonatal Intensive Care Unit (NICU). Infants who are
      clinically unstable, require surgery, have major congenital anomalies or have a history of
      severe birth asphyxia will be excluded.

      After parental consent, infants will be randomized to receive massage on study day 1 or study
      day 2. Standard care will be provided on the alternate study day. A minimum of 30 infants is
      required to complete the study. The primary outcome measure used to document the response to
      massage will measured by the Motionlogger® Micro Sleep Watch® Actigraph (Actigraph). The
      actigraph will be placed on the infant's ankle approximately following the 9 am feed and will
      record lower extremity activity until approximately the 12 pm feed. Massages will occur after
      a minimum of 30 minutes following the morning feeding when the infant is in a quiet alert
      state and will be approximately 10 minutes in length. Baby lotion used as standard care in
      the NICU will be used to facilitate ease of massage.

      Primary outcome measures will include data recorded by the actigraph: (a) sleep onset
      following massage intervention, (b) sleep end time, (c) number of awakenings and duration of
      awakenings during the study interval, (d) the duration of the longest sustained sleep period,
      and (e) sleep efficiency. Secondary outcomes will include oxygen saturation and heart rate
      during massage and for 30 minutes after massage.
    

Intervention name(s): Massage therapy
Intervention type(s): Other
Intervention description(s): An overall massage time of approximately 10 minutes, administered by physical therapists. Almond oil or baby lotion that is currently used in standard care in the ACH NICU will be used to assist with ease of skin to skin contact during moderate pressure massage. Infants will receive two repetitions of 5-1minute periods of 12 strokes lasting approximately 5 seconds each described in protocol. Actigraph device is on infant's ankle to measure sleep.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: premature infant; massage therapy; sleep induction; relaxation