Premature Birth of Newborn Clinical Trial
Official title:
Effects of Massage Therapy to Induce Sleep in Preterm Infants
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.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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