Prematurity, Very Preterm Maturity of Infant
Conditions
Keywords
sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying
Brief summary
The goal of this clinical trial is to compare sleeping in a SNOO Smart Sleeper bassinet (SNOO) with sleeping in traditional bassinet conditions in premature infants. The main questions it aims to answer are: 1. Do preterm infants who sleep in the SNOO have more quiet sleep? 2. Do preterm infants who sleep in the SNOO have improved vital signs? * Participants will spend two separate three-hour periods sleeping in either a SNOO (which plays white noise and rocks from side-to-side) or in a SNOO that remains off (does not play white noise and does not move). There will be at least one week separating these sleep assessments. * Participants will have their sleep stage and vital signs monitored (heart rate and oxygen levels). * Participants will also wear two stickers on their forehead that measure brain oxygen levels (NIRS) and brain waves (EEG). There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.
Detailed description
Sleep plays an important role in the brain growth and development of preterm infants. Neonatal sleep is made up of three stages of sleep: quiet sleep, active sleep, and transitional sleep. Poor sleep can be a result of premature birth itself as well as from simply being in the neonatal intensive care unit (NICU) environment. The interruptions that these infants are exposed to include frequent cares, physical exams, lights, and noises. The investigators are interested in the potential positive effects on sleep of recreating the environment of the womb. The SNOO is a bassinet that uses the combination of a secure swaddle, white noise, and gentle rocking movements to mimic the conditions that infants were exposed to in the uterus before being born. The investigators are interested in studying how recreating this environment of within the womb impacts the sleep-wake cycles of premature infants. To do this, the investigators will measure the amount of time that premature infants spent asleep versus awake while in the SNOO through behavior observations, electroencephalogram (brain activity monitoring), and vital signs. The investigators hypothesize that sleeping in the SNOO will increase the amount of time that the premature infants spend in quiet sleep and will improve their vital signs.
Interventions
DEVICESNOO Smart Sleeper
Infants will be secured in the SNOO Sleep Sack. They will be placed in the center of the SNOO Smart Sleeper. The SNOO will be powered on and will start playing white noise and rocking from side-to-side. The SNOO's movement and sound settings will automatically ramp up and down as needed in response to the infant's sensed level of fussiness or crying per the manufacturer's programming. The preemie mode will be enabled, which caps motion at level 2 out of 5.
DEVICETraditional bassinet
Infants will be swaddled using a standard hospital blanket. They will be placed in the center of the SNOO Smart Sleeper, but the SNOO will be left powered-off. No white noise will be played. No side-to-side rocking motions will occur.
Sponsors
Happiest Baby, Inc.
Columbia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
Participants will be randomized to either the traditional bassinet condition or the SNOO Smart Sleeper. Depending on the group to which they are assigned, participants will spend six hours total (divided between two time points) under either the traditional bassinet conditions or in the SNOO Smart Sleeper while having a sleep assessment performed. The first sleep assessment will occur at 35-36 weeks postmenstrual age, and the second will occur at term-equivalent age (37 weeks or greater). Each sleep assessment will last three hours and will occur between feeds (2:00 p.m. to 5:00 p.m.).
Eligibility
Sex/Gender
ALL
Age
1 Weeks to 12 Weeks
Healthy volunteers
Yes
Inclusion criteria
* Inpatients at the Morgan Stanley Children's Hospital NICU. * Singleton gestation. * Gestational age 28w0d to 36w6d at birth. * Postmenstrual age greater than 35 weeks at the time of the intervention. * Weight greater than 1.8 kg and less than 11.3 kg. * Stable thermoregulation in an open crib. * Stable respiratory status on room air (no nasal cannula or CPAP). * Normal head ultrasound (if obtained).
Exclusion criteria
* Congenital brain or spinal anomalies. * Intracranial hemorrhage. * Severe encephalopathy. * Known or suspected genetic syndromes that could result in cerebral dysfunction. * Airway anomalies that could result in sleep-disordered breathing. * Bleeding diatheses. * Status post surgery or minor surgical procedures (i.e. inguinal hernia repair, circumcision). * Fetal opioid exposure. * Administration of sedating agents over the past 24 hours. * Ability to independently roll to hands and knees.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Quiet Sleep Time During 3-hour Sleep Assessment | At baseline sleep assessment, up to 3 hours | Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid rag doll appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Heart Rate Variability | Up to 3 hours | Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation. |
| Change in Cerebral Oxygenation | Up to 3 hours | Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS). |
| Change in Oxygen Saturation | Up to 3 hours | Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry. |
| Change in Intermittent Hypoxemic Event Frequency | Up to 3 hours | Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| SNOO Group The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. | 11 |
| Traditional Bassinet Group The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. | 9 |
| Total | 20 |
Baseline characteristics
| Characteristic | SNOO Group | Total | Traditional Bassinet Group |
|---|---|---|---|
| Age, Continuous | 32.9 weeks STANDARD_DEVIATION 1.9 | 33.1 weeks STANDARD_DEVIATION 1.7 | 33.5 weeks STANDARD_DEVIATION 1.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 8 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 6 Participants | 10 Participants | 4 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 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 | 5 Participants | 9 Participants | 4 Participants |
| Race (NIH/OMB) White | 4 Participants | 6 Participants | 2 Participants |
| Region of Enrollment United States | 11 participants | 20 participants | 9 participants |
| Sex: Female, Male Female | 5 Participants | 10 Participants | 5 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 11 | 0 / 9 |
| other Total, other adverse events | 0 / 11 | 0 / 9 |
| serious Total, serious adverse events | 0 / 11 | 0 / 9 |
Outcome results
Primary
Percent of Quiet Sleep Time During 3-hour Sleep Assessment
Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid rag doll appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds.
Time frame: At baseline sleep assessment, up to 3 hours
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| SNOO Group | Percent of Quiet Sleep Time During 3-hour Sleep Assessment | 26.8 percent | Standard Deviation 9.5 |
| Traditional Bassinet Group | Percent of Quiet Sleep Time During 3-hour Sleep Assessment | 19.8 percent | Standard Deviation 5.1 |
Secondary
Change in Cerebral Oxygenation
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
Time frame: Up to 3 hours
Secondary
Change in Heart Rate Variability
Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation.
Time frame: Up to 3 hours
Secondary
Change in Intermittent Hypoxemic Event Frequency
Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.
Time frame: Up to 3 hours
Secondary
Change in Oxygen Saturation
Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.
Time frame: Up to 3 hours