Premature Birth of Newborn Clinical Trial
Official title:
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Verified date | April 2013 |
Source | University of Arkansas |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 30 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A to 20 Weeks |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Country | Name | City | State |
---|---|---|---|
United States | Arkansas Children's Hospital | Little Rock | Arkansas |
Lead Sponsor | Collaborator |
---|---|
University of Arkansas |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Primary | 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 | No |
Secondary | 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 | Yes |
Secondary | Heart Rate | Heart rate during massage therapy | During massage therapy | Yes |
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