Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
NCT ID: NCT05711927
Last Updated: 2025-09-15
Study Results
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View full resultsBasic Information
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COMPLETED
NA
20 participants
INTERVENTIONAL
2023-03-16
2025-06-02
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.).
SUPPORTIVE_CARE
NONE
Study Groups
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SNOO group
The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.
SNOO 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.
Traditional bassinet group
The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
Traditional 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.
Interventions
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SNOO 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.
Traditional 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
1 Week
12 Weeks
ALL
Yes
Sponsors
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Happiest Baby, Inc.
INDUSTRY
Columbia University
OTHER
Responsible Party
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Rakesh Sahni
Medical Director of the Neonatal Intensive Care Unit at NewYork-Presbyterian/Morgan Stanley Children's Hospital
Principal Investigators
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Rakesh Sahni, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Locations
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Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian
New York, New York, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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AAAU2315
Identifier Type: -
Identifier Source: org_study_id
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