Effects of Massage Therapy to Induce Sleep in Preterm Infants

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Massage Therapy to Induce Sleep in Preterm Infants

Conditions
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Premature Birth of Newborn

Intervention / Treatment
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* Other: Massage therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Days
Maximum Age: 20 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Massage therapy<br>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<br>* 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.<br>|
| No Intervention: No massage therapy<br>This was a crossover trial with two arms. On one day, infants received massage therapy for 10 minutes. On the other day, infants were monitored as usual with the Actigraph to measure sleep efficiency, but received no massage therapy. This was the control or no intervention arm. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Sleep, Defined by Number and Duration of Awakenings, and Longest Sustained Sleep Period for the Study Interval. These Data Were Measured by the Actigraph Software and Summarized as Percentage of Time Spent Sleeping, or Sleep Efficiency | 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 Percentage of time spent sleeping, or sleep efficiency, will be used to summarize the data, comparing sleep efficiency over 2 days and using each infant as his/her own control | Participants were followed for two days | 
| Number of Infants Sleeping at the End of the Massage Period | Investigators compared the number of infants sleeping at the end of the massage period with the percentage of infants sleeping at the same time on the non massage day. | Minute massage ended | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygen Saturation Levels During Massage | Infants in the NICU are routinely attached to pulse oximeter monitors that measure oxygen saturation continuously. If the infant is stressed, oxygen levels may drop. Oxygen saturation was monitored during massage therapy as a routine measure but also to ensure that infants did not become stressed during the massage. | During massage | 
| Heart Rate | Heart rate during massage therapy | During massage therapy | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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relaxation, premature infant, massage therapy, sleep induction