Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

Study Overview
=================
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: Do preterm infants who sleep in the SNOO have more quiet sleep? 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.

Official Title
-----------------
The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants

Conditions
-----------------
Prematurity, Very Preterm Maturity of Infant

Intervention / Treatment
-----------------
* Device: SNOO Smart Sleeper
* Device: Traditional bassinet


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 1 Week
Maximum Age: 12 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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.).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SNOO group<br>The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. | Device: SNOO Smart Sleeper<br>* 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.<br>|
| Sham Comparator: Traditional bassinet group<br>The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. | Device: Traditional bassinet<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in amount of quiet sleep time | 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. | Within one week of weaning from isolette to open crib (approximately 35-36 weeks postmenstrual age) and within one week of discharge from NICU (approximately 37-40 weeks postmenstrual age) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Within one week of weaning from isolette to open crib (approximately 35-36 weeks postmenstrual age) and within one week of discharge from NICU (approximately 37-40 weeks postmenstrual age) | 
| Change in cerebral oxygenation | Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS). | Within one week of weaning from isolette to open crib (approximately 35-36 weeks postmenstrual age) and within one week of discharge from NICU (approximately 37-40 weeks postmenstrual age) | 
| Change in oxygen saturation | Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry. | Within one week of weaning from isolette to open crib (approximately 35-36 weeks postmenstrual age) and within one week of discharge from NICU (approximately 37-40 weeks postmenstrual age) | 
| Change in intermittent hypoxemic event frequency | Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry. | Within one week of weaning from isolette to open crib (approximately 35-36 weeks postmenstrual age) and within one week of discharge from NICU (approximately 37-40 weeks postmenstrual age) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying