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Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

Primary Purpose

Prematurity, Very Preterm Maturity of Infant

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SNOO Smart Sleeper
Traditional bassinet
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying

Eligibility Criteria

1 Week - 12 Weeks (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

SNOO group

Traditional bassinet group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Change in cerebral oxygenation
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
Change in oxygen saturation
Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.
Change in intermittent hypoxemic event frequency
Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.

Full Information

First Posted
January 25, 2023
Last Updated
September 5, 2023
Sponsor
Columbia University
Collaborators
Happiest Baby, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05711927
Brief Title
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
Official Title
The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 16, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
Happiest Baby, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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: Do preterm infants who sleep in the SNOO have more quiet sleep? 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Very Preterm Maturity of Infant
Keywords
sleep, SNOO, bassinet, white noise, rocking, swaddle, intrauterine environment, crying

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SNOO group
Arm Type
Experimental
Arm Description
The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.
Arm Title
Traditional bassinet group
Arm Type
Sham Comparator
Arm Description
The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
Intervention Type
Device
Intervention Name(s)
SNOO Smart Sleeper
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Traditional bassinet
Intervention Description
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 Outcome Measure Information:
Title
Change in amount of quiet sleep time
Description
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.
Time Frame
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 Outcome Measure Information:
Title
Change in heart rate variability
Description
Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation.
Time Frame
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)
Title
Change in cerebral oxygenation
Description
Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS).
Time Frame
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)
Title
Change in oxygen saturation
Description
Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry.
Time Frame
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)
Title
Change in intermittent hypoxemic event frequency
Description
Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry.
Time Frame
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)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Week
Maximum Age & Unit of Time
12 Weeks
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Toni Iurcotta, MD
Phone
646-532-8196
Email
ti2241@cumc.columbia.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rakesh Sahni, MD
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Toni Iurcotta, MD
Phone
646-532-8196
Email
ti2241@cumc.columbia.edu
First Name & Middle Initial & Last Name & Degree
Rakesh Sahni, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided
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Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

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