N/A
N=30
Effects of Massage Therapy to Induce Sleep in Preterm Infants
Premature Birth of Newborn
Bottom Line
View on ClinicalTrials.gov: NCT01354028 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcome: 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 — 78.7; 77.8 percentage of time spent sleeping — p=0.1303
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Massage therapy (Other)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- University of Arkansas
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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 |
78.7; 77.8 | 0.1303 |
| PRIMARY Number of Infants Sleeping at the End of the Massage Period |
7; 14 | 0.026 sig |
| SECONDARY Oxygen Saturation Levels During Massage |
99.7; 99.3 | — |
| SECONDARY Heart Rate |
162.5; 169.45 | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01354028). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.