Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

Prematurity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05711927
• Other study ID #: AAAU2315
• Status: Recruiting
• Phase: N/A
• Start date: March 16, 2023
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: Columbia University
• Contact: Toni Iurcotta, MD
• Phone: 646-532-8196
• Email: ti2241[@]cumc.columbia.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Week to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Premature Birth
• Prematurity
• Very Preterm Maturity of Infant

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian	New York	New York

Sponsors (2)

Lead Sponsor	Collaborator
Columbia University	Happiest Baby, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (13)

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

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
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).	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	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)
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.	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)