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Effects of Massage Therapy to Induce Sleep in Preterm Infants

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Arkansas
ClinicalTrials.gov Identifier:
NCT01354028
First received: May 12, 2011
Last updated: December 6, 2012
Last verified: December 2012
History of Changes
  Purpose

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.


Condition Intervention
Premature Birth of Newborn
 Other: Massage therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Effects of Massage Therapy to Induce Sleep in Preterm Infants

Resource links provided by NLM:

MedlinePlus related topics: Premature Babies
U.S. FDA Resources

Further study details as provided by University of Arkansas:

Primary Outcome Measures:
  • Sleep [ Time Frame: Beginning with the first quiet alert state of he infant following the 9 AM feeding and measure until the noon feed ] [ Designated as safety issue: No ]
    Sleep onset following the first quiet alert state after the 9 AM feed Sleep end time Number of awakenings and duration of the awakenings during the study period Longest sustained sleep period for the study interval Sleep efficiency


Secondary Outcome Measures:
  • Vital signs [ Time Frame: During and for 30 minutes after massage ] [ Designated as safety issue: Yes ]
    Oxygen saturation during and for 30 minutes after massage Heart rate during and for 30 minutes after massage


Enrollment: 30
Study Start Date: March 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Massage therapy
Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours.
 Other: Massage therapy
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.

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.

  Eligibility

Ages Eligible for Study:   up to 20 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • > 3 days old
  • 32-48 weeks adjusted gestational age
  • Minimum of 28 weeks gestational age at birth
  • Clinically stable as determined by an neonatologist
  • Stable respiratory status on room air or nasal cannula flow <2 LPM
  • Not meeting exclusion criteria

Exclusion Criteria:

  • Documented maternal opiate use prior to admission to Labor and Delivery (opiates administered by physicians' order during labor prior to delivery do not mandate exclusion from the study as long as the mother does not have a past history of opiate abuse or a positive drug screen at hospital admission prior to delivery).
  • Clinically unstable and/or unable to be moved from the infant warmer
  • Severe congenital anomalies likely to be associated with developmental delay
  • Apgar score of ≤ 3 at 5 minutes of age
  • Any other condition that in the opinion of the investigator might result in unnecessary or excessive risk to the subject
  • Unstable respiratory status
  • Sedation in the previous 24 hours before the infant's trial.
  • Neurological disease: grade III or IV intraventricular hemorrhage, periventricular leukomalacia, evidence of hypoxic ischemic encephalopathy
  • Anticipated painful procedures during the study period between 9 am and 12 pm
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354028

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
University of Arkansas
Investigators
Principal Investigator: Richard W Hall, M.D. University of Arkansas
  More Information

No publications provided

Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT01354028     History of Changes
Other Study ID Numbers: 130342
Study First Received: May 12, 2011
Last Updated: December 6, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Arkansas:
premature infant
massage therapy
sleep induction
relaxation

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013