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| Name | Class |
|---|---|
| Happiest Baby, Inc. | INDUSTRY |
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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?
There is a chance that the infant may experience more restful sleep and improved vital signs during the 2 sleep assessments.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SNOO group | Experimental | The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. |
|
| Traditional bassinet group | Sham Comparator | The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SNOO Smart Sleeper | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline sleep assessment, up to 3 hours |
| 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. | Up to 3 hours |
| Change in Cerebral Oxygenation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rakesh Sahni, MD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian | New York | New York | 10032 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21942583 | Background | 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. | |
| 25635585 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | SNOO Group | The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. |
| FG001 | Traditional Bassinet Group | The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | SNOO Group | The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. |
| BG001 | Traditional Bassinet Group | The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | percent | At baseline sleep assessment, up to 3 hours |
|
During sleep time (approx 3 hours) at baseline sleep assessment
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | SNOO Group | The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions. |
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All infants were discharged from the NICU after the 1st sleep assessment and were therefore not able to do a 2nd sleep assessment as outlined in the protocol, so the results presented in this record only reflects data collected from one 3-hour sleep assessment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Toni Iurcotta, MD | Columbia University Irving Medical Center | 646-532-8196 | ti2241@cumc.columbia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 27, 2023 | Jun 17, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D019956 | Stereotypic Movement Disorder |
| D003448 | Crying |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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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.).
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|
| Traditional bassinet | Device | 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. |
|
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
| Up to 3 hours |
| Change in Oxygen Saturation | Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry. | Up to 3 hours |
| Change in Intermittent Hypoxemic Event Frequency | Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry. | Up to 3 hours |
| 35173301 | Background | 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. |
| 21289534 | Background | 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. |
| 21976396 | Background | 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. |
| 34438595 | Background | 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. |
| 2405784 | Background | 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. |
| 28711233 | Background | 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. |
| 21911350 | Background | 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. |
| 29053622 | Background | Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090. |
| 22391640 | Background | 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. |
| 29412484 | Background | 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. |
| 27362468 | Background | 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. |
| BG002 | Total | Total of all reporting groups |
| Standard Deviation |
| weeks |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
| 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. | Not Posted | Jun 2026 | Up to 3 hours | Participants |
| 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). | Not Posted | Jun 2026 | Up to 3 hours | Participants |
| Secondary | Change in Oxygen Saturation | Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry. | Not Posted | Jun 2026 | Up to 3 hours | Participants |
| 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. | Not Posted | Jun 2026 | Up to 3 hours | Participants |
| 0 |
| 11 |
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Traditional Bassinet Group | The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet. | 0 | 9 | 0 | 9 | 0 | 9 |
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| D000091642 | Urogenital Diseases |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
| D009633 | Nonverbal Communication |
| D003142 | Communication |
| D001519 | Behavior |