Clinical trial NCT05711927: Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
Official title: The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prematurity
Very Preterm Maturity of Infant
Keywords: sleep
SNOO
bassinet
white noise
rocking
swaddle
intrauterine environment
crying
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: Happiest Baby, Inc.
First posted: 2023-02-03
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.).
Primary purpose: SUPPORTIVE_CARE

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.

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.

Primary outcomes:
measure: Change in amount of quiet sleep time
timeFrame: 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 outcomes:
measure: Change in heart rate variability
timeFrame: 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)
measure: Change in cerebral oxygenation
timeFrame: 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)
measure: Change in oxygen saturation
timeFrame: 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)
measure: Change in intermittent hypoxemic event frequency
timeFrame: 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)
Other outcomes:
Locations:
city: New York
country: United States
facility: Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian
state: New York
Study officials:
affiliation: Columbia University
name: Rakesh Sahni, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Calciolari G, Montirosso R. The sleep protection in the preterm infants. J Matern Fetal Neonatal Med. 2011 Oct;24 Suppl 1:12-4. doi: 10.3109/14767058.2011.607563.
citation: Santos J, Pearce SE, Stroustrup A. Impact of hospital-based environmental exposures on neurodevelopmental outcomes of preterm infants. Curr Opin Pediatr. 2015 Apr;27(2):254-60. doi: 10.1097/MOP.0000000000000190.
citation: Zhang X, Spear E, Hsu HL, Gennings C, Stroustrup A. NICU-based stress response and preterm infant neurobehavior: exploring the critical windows for exposure. Pediatr Res. 2022 Nov;92(5):1470-1478. doi: 10.1038/s41390-022-01983-3. Epub 2022 Feb 16.
citation: Johnson S, Marlow N. Preterm birth and childhood psychiatric disorders. Pediatr Res. 2011 May;69(5 Pt 2):11R-8R. doi: 10.1203/PDR.0b013e318212faa0.
citation: Smith GC, Gutovich J, Smyser C, Pineda R, Newnham C, Tjoeng TH, Vavasseur C, Wallendorf M, Neil J, Inder T. Neonatal intensive care unit stress is associated with brain development in preterm infants. Ann Neurol. 2011 Oct;70(4):541-9. doi: 10.1002/ana.22545. Epub 2011 Oct 4.
citation: Restin T, Gaspar M, Bassler D, Kurtcuoglu V, Scholkmann F, Haslbeck FB. Newborn Incubators Do Not Protect from High Noise Levels in the Neonatal Intensive Care Unit and Are Relevant Noise Sources by Themselves. Children (Basel). 2021 Aug 16;8(8):704. doi: 10.3390/children8080704.
citation: Spencer JA, Moran DJ, Lee A, Talbert D. White noise and sleep induction. Arch Dis Child. 1990 Jan;65(1):135-7. doi: 10.1136/adc.65.1.135.
citation: Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12.
citation: Weisman O, Magori-Cohen R, Louzoun Y, Eidelman AI, Feldman R. Sleep-wake transitions in premature neonates predict early development. Pediatrics. 2011 Oct;128(4):706-14. doi: 10.1542/peds.2011-0047. Epub 2011 Sep 12.
citation: Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090.
citation: Kuhn P, Zores C, Pebayle T, Hoeft A, Langlet C, Escande B, Astruc D, Dufour A. Infants born very preterm react to variations of the acoustic environment in their incubator from a minimum signal-to-noise ratio threshold of 5 to 10 dBA. Pediatr Res. 2012 Apr;71(4 Pt 1):386-92. doi: 10.1038/pr.2011.76. Epub 2012 Feb 15.
citation: Zores C, Dufour A, Pebayle T, Dahan I, Astruc D, Kuhn P. Observational study found that even small variations in light can wake up very preterm infants in a neonatal intensive care unit. Acta Paediatr. 2018 Jul;107(7):1191-1197. doi: 10.1111/apa.14261. Epub 2018 Feb 27.
citation: Levy J, Hassan F, Plegue MA, Sokoloff MD, Kushwaha JS, Chervin RD, Barks JD, Shellhaas RA. Impact of hands-on care on infant sleep in the neonatal intensive care unit. Pediatr Pulmonol. 2017 Jan;52(1):84-90. doi: 10.1002/ppul.23513. Epub 2016 Jun 30.