SNOO Smart Sleeper for Premature Infants
Trial Summary
Do I need to stop my baby's current medications for the trial?
The trial protocol does not specify whether you need to stop your baby's current medications. However, if your baby has been given sedating agents in the past 24 hours, they cannot participate.
What data supports the effectiveness of the treatment SNOO Smart Sleeper Bassinet for premature infants?
The research on safe sleep practices shows that using a bassinet can improve safe sleep environments for infants, which is important for reducing risks like sudden infant death syndrome (SIDS). Additionally, interventions that improve sleep positioning and environment, similar to what the SNOO Smart Sleeper aims to provide, have been shown to enhance infant sleep safety and quality.12345
Is the SNOO Smart Sleeper safe for premature infants?
The SNOO Smart Sleeper has been evaluated in the context of safe sleep strategies for infants, which aim to reduce risks like sudden infant death. While specific safety data for the SNOO Smart Sleeper itself isn't detailed, general safe sleep practices have been studied extensively, showing that proper sleep environments can help protect infants.24678
How does the SNOO Smart Sleeper Bassinet treatment differ from other treatments for premature infants?
The SNOO Smart Sleeper Bassinet is unique because it is designed to provide a soothing environment that mimics the womb, using gentle rocking and white noise to help premature infants sleep better. Unlike traditional bassinets or other sleep devices, it offers automated features that respond to the baby's needs, potentially improving sleep quality and reducing parental fatigue.2391011
What is the purpose of this trial?
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.
Research Team
Rakesh Sahni, MD
Principal Investigator
Columbia University
Eligibility Criteria
This trial is for preterm infants weighing between 1.8 to 11.3 kg, born at a gestational age of 28-36 weeks, and now over 35 weeks postmenstrual age. They must be stable in an open crib without respiratory support and not have had recent surgery, brain injuries, opioid exposure or sedatives.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Sleep Assessment
Participants will spend two separate three-hour periods sleeping in either a SNOO or in a SNOO that remains off, with at least one week separating these sleep assessments.
Follow-up
Participants are monitored for changes in heart rate variability, cerebral oxygenation, and oxygen saturation within one week of weaning from isolette to open crib and within one week of discharge from NICU.
Treatment Details
Interventions
- SNOO Smart Sleeper Bassinet
- Traditional Bassinet
Find a Clinic Near You
Who Is Running the Clinical Trial?
Columbia University
Lead Sponsor
Happiest Baby, Inc.
Industry Sponsor
Happiest Baby, Inc.
Collaborator