Pain, Preterm Birth
Conditions
Keywords
Music Based Intervention, Preterm Infant Pain Profile
Brief summary
Pilot prospective randomized, double blinded, controlled study to test effect of music based intervention (MBI) on pain response and neurodevelopment in preterm infants.
Detailed description
Aim 1: Premature infant pain profiles (PIPP) include physiologic, behavioral, and contextual measures which identifies differences in pain responses between music-based intervention (MBI) and controls while still in the neonatal intensive care unit (NICU). Central EEG amplitude changes have been time-locked with painful procedures in term infants. We will explore if PIPP scores and central EEG amplitude changes are attenuated with MBI in comparison to controls. Hypothesis 1: MBI will show improved pain responses, with lower PIPP scores and attenuated central EEG amplitude changes during painful procedures, in comparison to the control cohort. Aim 2: EEG is a surrogate marker for real time brain function during sleep-wake cycles. Because preterm brain networks develop during sleep, sleep duration is a strong indicator of brain maturation. Serial biweekly EEGs of preterm infants can quantify sleep duration trends and track MBI's influence on sleep. To enhance objectivity, innovative EEG machine-learning tools will be applied to the analyses. Hypothesis 2: MBI will enhance preterm EEG brain maturation in comparison to controls. Due to the natural limitations of evaluating immature neonatal nervous systems, ERPs have been utilized to study early neurodevelopment. ERPs quantify electrical brain potentials changes time-locked with a stimulus. Auditory ERPs performed at 1 month corrected age evaluates attention and discrimination between familiar and novel stimuli - early neurodevelopmental signs of recognition memory function and perceptual learning. Hypothesis 3: ERPs at 1 month corrected age will show that MBI has a greater impact on early neurodevelopment when compared to controls.
Interventions
Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player.
OTHERSham Treatment
Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones.
Sponsors
National Center for Complementary and Integrative Health (NCCIH)
University of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Blinding will be maintained by using identical headphones and MP3 players for all subjects. The PI, any personnel involved in collecting the clinical outcomes (e.g., PIPP) or collecting or quantifying EEG outcomes, and the statistician will be blinded.
Eligibility
Sex/Gender
ALL
Age
28 Weeks to 32 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Preterm infant born at 30 weeks (+/- 2 weeks) * Medically stable
Exclusion criteria
* Treatment for major organ system disease * Significant neurological disorder including, but not limited to, abnormal neurological examination, neonatal abstinence syndrome, intraventricular hemorrhage, seizures, meningitis, or congenital brain malformations * Scalp lesions affecting EEG placement
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Premature Infant Pain Profile (PIPP) Score | 2 weeks | The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Participants in this group will be randomized to receive the intervention.
Music Based Intervention: Participants assigned to MBI will receive a total of 1.5 hours of music intervention 5-6 sessions per week. Music will be alternating: 30 minutes on and 30 minutes off and will be played when the subject is awake to cue pacification and initiate the sleep process. Music will be delivered through headphones using an MP3 player. | 14 |
| Placebo Participants in this group will be randomized to receive a sham treatment.
Sham Treatment: Participants assigned to the control group will have the same treatment as the MBI group, but with no sound played through the headphones. | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Intervention | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 14 Participants | 14 Participants | 28 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) White | 12 Participants | 13 Participants | 25 Participants |
| Sex: Female, Male Female | 3 Participants | 9 Participants | 12 Participants |
| Sex: Female, Male Male | 11 Participants | 5 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Premature Infant Pain Profile (PIPP) Score
The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain.
Time frame: 2 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Premature Infant Pain Profile (PIPP) Score | 6.8 unit in a scale | Standard Deviation 3.6 |
| Placebo | Premature Infant Pain Profile (PIPP) Score | 7.8 unit in a scale | Standard Deviation 3.7 |
Primary
Premature Infant Pain Profile (PIPP) Score
The Premature Infant Pain Profile (PIPP) is a pain scoring system assessing 7 indicators: observed change in heart rate, observed decrease in percent oxygen saturation; observed facial expressions of pain (brow bulge, eye squeeze, and naso-labial furrow); gestational age; and behavioral state. Clinicians rate each indicator on a scale from 0 to 3 using a set scoring system. Total scores range 0 to 21, with higher scores indicating greater pain.
Time frame: 4 weeks
Population: .All other outcome measures besides 1 were considered separate. Each outcome measure had a different number of participants who completed that portion of the study. The ERP (Event Related Potential) measure only had one participant attend. Ultimately, the number of participants analyzed should be based on the first primary outcome measure of pain profile.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Premature Infant Pain Profile (PIPP) Score | 6.3 unit in a scale | Standard Deviation 2.7 |
| Placebo | Premature Infant Pain Profile (PIPP) Score | 6.4 unit in a scale | Standard Deviation 3.5 |