Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

NCT05711927 | Completed Results FDA Device

• 1 other identifier: AAAU2315
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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:

• 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.

Conditions

Prematurity; Very Preterm Maturity of Infant

Keywords

sleep; SNOO; bassinet; white noise; rocking; swaddle; intrauterine environment; crying

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Change in Heart Rate Variability

  Up to 3 hours

• Change in Cerebral Oxygenation

  Up to 3 hours

• Change in Oxygen Saturation

  Up to 3 hours

• Change in Intermittent Hypoxemic Event Frequency

  Up to 3 hours

Study Arms (2)

SNOO group

EXPERIMENTAL

The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.

Device: SNOO Smart Sleeper

Traditional bassinet group

SHAM COMPARATOR

The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.

Device: Traditional bassinet

Interventions

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.

SNOO group

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.

Traditional bassinet group

Eligibility Criteria

• Age: 1 Week - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Columbia University: lead
• Happiest Baby, Inc.: collaborator

Study Sites (1)

Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian

New York, New York, 10032, United States

Location

Related Publications (13)

• 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.

  PMID: 21942583 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.

  PMID: 25635585 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.

  PMID: 35173301 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.

  PMID: 21289534 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.

  PMID: 21976396 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.

  PMID: 34438595 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.

  PMID: 2405784 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.

  PMID: 28711233 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.

  PMID: 21911350 BACKGROUND

• Barbeau DY, Weiss MD. Sleep Disturbances in Newborns. Children (Basel). 2017 Oct 20;4(10):90. doi: 10.3390/children4100090.

  PMID: 29053622 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.

  PMID: 22391640 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.

  PMID: 29412484 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.

  PMID: 27362468 BACKGROUND

MeSH Terms

Conditions

Premature Birth; Stereotypic Movement Disorder; Crying

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Neurodevelopmental Disorders; Mental Disorders; Nonverbal Communication; Communication; Behavior

Limitations and Caveats

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.

Results Point of Contact

• Title: Toni Iurcotta, MD
• Organization: Columbia University Irving Medical Center

ti2241@cumc.columbia.edu

646-532-8196

Study Officials

• Rakesh Sahni, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the Neonatal Intensive Care Unit at NewYork-Presbyterian/Morgan Stanley Children's Hospital

Model Details: 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.).

Study Record Dates

• First Submitted: January 25, 2023
• First Posted: February 3, 2023
• Study Start: March 16, 2023
• Primary Completion: May 31, 2024
• Study Completion: June 2, 2025
• Last Updated: September 15, 2025
• Results First Posted: September 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)