Premature Birth of Newborn
Conditions
Keywords
premature infant, massage therapy, sleep induction, relaxation
Brief summary
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
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.
Interventions
OTHERMassage 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.
Sponsors
University of Arkansas
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Days to 20 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Participants were followed for two days | 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 |
| Number of Infants Sleeping at the End of the Massage Period | Minute massage ended | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oxygen Saturation Levels During Massage | 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. |
| Heart Rate | During massage therapy | Heart rate during massage therapy |
Countries
United States
Participant flow
Recruitment details
Infants were recruited from the Neonatal Intensive Care Unit (NICU) at a Children's Hospital. Recruitment dates were 03/09/2011 to 05/09/2012. A total of 30 infants were enrolled.
Pre-assignment details
Seven infants were enrolled but did not complete the study. Two infants developed medical complications before the study and therefore became ineligible. Four infants were discharged before the study began. One infant did not have a quiet alert state after feeding and the study was discontinued at that point with no data collected.
Participants by arm
| Arm | Count |
|---|---|
| Massage Therapy Massage therapy for 10 minutes during quiet alert state following 9 AM feeding. Actigraph in place to measure sleep for 3 hours. | 30 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Discharged before study start | 2 | 2 |
| Overall Study | No quiet alert state | 0 | 1 |
| Overall Study | Physician Decision | 0 | 2 |
Baseline characteristics
| Characteristic | Massage Therapy |
|---|---|
| Age, Customized newborn infant >3 days | 30 participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: Minute massage ended
Population: A convenient number of infants was determined for this pilot study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Sleep Efficiency With Massage Therapy | Number of Infants Sleeping at the End of the Massage Period | 7 participants |
| Sleep Efficiency With no Massage Therapy | Number of Infants Sleeping at the End of the Massage Period | 14 participants |
Comparison: Null hypothesis: there is no difference in massage therapy or no massage therapy in number of infants who will be asleep at the end of massage or the corresponding time frame on the non massage day.~Pearson's chi square=4.98p-value: 0.026Chi-squared
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
Time frame: Participants were followed for two days
Population: A convenient number of participants was selected for this pilot study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Efficiency With Massage Therapy | 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 | 78.7 percentage of time spent sleeping | Standard Deviation 20 |
| Sleep Efficiency With no Massage Therapy | 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 | 77.8 percentage of time spent sleeping | Standard Deviation 21.4 |
Comparison: Null hypothesis: there will be no difference in sleep efficiency in preterm infants on the day of massage versus the day without massage.~Power calculation: the sample size was determined by convenience for this pilot studyp-value: 0.1303Chi-squared
Secondary
Heart Rate
Heart rate during massage therapy
Time frame: During massage therapy
Population: A convenient size was determined for this pilot study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Efficiency With Massage Therapy | Heart Rate | 162.5 beats per minute | Standard Deviation 12.7 |
| Sleep Efficiency With no Massage Therapy | Heart Rate | 169.45 beats per minute | Standard Deviation 12.86 |
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.
Time frame: During massage
Population: We determined a convenient size for this pilot study
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Sleep Efficiency With Massage Therapy | Oxygen Saturation Levels During Massage | 99.7 percentage of oxygen saturation | Standard Deviation 0.7 |
| Sleep Efficiency With no Massage Therapy | Oxygen Saturation Levels During Massage | 99.3 percentage of oxygen saturation | Standard Deviation 1.18 |