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Completed

NCT Number: NCT05711927

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

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.

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Key information

Conditions

Prematurity Behavior Communication Crying Female Urogenital Diseases and Pregnancy Complications Mental Disorders Neurodevelopmental Disorders Nonverbal Communication Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Stereotypic Movement Disorder Urogenital Diseases Very Preterm Maturity of Infant

Age range

1 week–12 week

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Percent of Quiet Sleep Time During 3-hour Sleep Assessment

    Time frame: At baseline sleep assessment, up to 3 hours

    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.

Secondary outcomes

  1. Change in Heart Rate Variability

    Time frame: Up to 3 hours

    Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation.

  2. Change in Cerebral Oxygenation

    Time frame: Up to 3 hours

    Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).

  3. Change in Oxygen Saturation

    Time frame: Up to 3 hours

    Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.

  4. Change in Intermittent Hypoxemic Event Frequency

    Time frame: Up to 3 hours

    Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • Happiest Baby, Inc.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2023
Registry last updated
Sep 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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