Effects of Massage Therapy to Induce Sleep in Preterm Infants

Completed · Not applicable

Conditions studied: Premature Birth of Newborn

In brief

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.

Key facts

Study ID

NCT01354028

Run by

University of Arkansas

People needed

30

Starts

2011-03-01

Expected to finish

2012-06-01

Last updated by the study team

2013-06-03

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• > 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

You may not qualify if…

• 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

Where it is running

• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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