SNOO Smart Sleeper for Premature Infants

Overseen By Toni Iurcotta, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Columbia University

Must not be taking: Sedating agents

Disqualifiers: Congenital brain anomalies, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

50 Participants Needed

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. ^{1 2 3 4 5}

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. ^{2 4 6 7 8}

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. ^{2 3 9 10 11}

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

Stable thermoregulation in an open crib

Inpatients at the Morgan Stanley Children's Hospital NICU

Singleton gestation

Exclusion Criteria

I have a genetic condition that affects my brain function.

I have airway problems that might cause sleep issues.

Congenital brain or spinal anomalies

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

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.

2 weeks

2 visits (in-person)

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.

2-4 weeks

Treatment Details

Interventions

• SNOO Smart Sleeper Bassinet
• Traditional Bassinet

Trial Overview The study compares the SNOO Smart Sleeper bassinet's effects on sleep quality and vital signs against traditional bassinets in premature infants. Infants will try both sleeping conditions with one week apart while their sleep stages, heart rate, oxygen levels are monitored.

Participant Groups

Group I: SNOO group Experimental Treatment 1 Intervention

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

Group II: Traditional bassinet group Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Columbia University

Lead Sponsor

Trials

1,529

Recruited

2,832,000+

Happiest Baby, Inc.

Industry Sponsor

Trials

3

Recruited

1,200+

Happiest Baby, Inc.

Collaborator

Trials

2

Recruited

160+

Findings from Research

The study involving 200 mainly Māori pregnant women found that using the wahakura sleep device did not increase risky infant behaviors such as bed-sharing or unsafe sleep positions compared to traditional bassinets.

Infants using the wahakura had a significantly higher rate of full breastfeeding at 6 months (22.5% vs 10.7%), suggesting that wahakura may support better breastfeeding practices while maintaining safety for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Wahakura Versus Bassinet for Safe Infant Sleep: A Randomized Trial. Baddock, SA., Tipene-Leach, D., Williams, SM., et al.[2021]

A systematic review of 29 studies on interventions to reduce sleep-related infant deaths found that multi-faceted approaches, including education and resource provision, were generally effective in changing some infant sleep practices, though complete adherence to safe sleep recommendations was not achieved.

Interventions targeted various behaviors such as sleep position and crib safety, and included methods like one-on-one education, printed materials, and health professional training, highlighting the importance of comprehensive strategies in promoting safe sleep for infants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Interventions, 1990-2015: A Review. Salm Ward, TC., Balfour, GM.[2022]

A quality improvement initiative using visual cues and nursing education significantly increased safe sleep practices in a low-volume nursery, improving compliance from 32% to 75%.

This study highlights the effectiveness of targeted interventions in promoting safe sleep environments for infants, which is crucial in reducing the risk of sudden infant death syndrome (SIDS).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modeling of infant safe sleep practice in a newborn nursery: a quality improvement initiative. Hsu, E., Isbell, L., Arnold, D., et al.[2023]

A systematic review of 12 articles on safe sleep strategies for infants identified 39 key evidence-based recommendations, which can guide clinical practices and policy formulation for infant sleep safety.

The quality evaluation of the guidelines showed high standards, with one guideline rated 'A' and two rated 'B', indicating strong support for implementing these safe sleep strategies in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Evidence summary for safety sleep protection strategy in infants]. Zayagerili, ., Hou, R., Chen, M., et al.[2021]

The American Academy of Pediatrics updated their safe sleep guidelines for infants, emphasizing the importance of healthcare providers modeling safe sleep behaviors, which is crucial for effective communication with families during hospital stays.

A quality improvement project implemented five family-centered interventions, including a safe sleep web page and bedside guides, which successfully enhanced sleep safety for hospitalized infants by fostering collaboration among healthcare providers and families.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Interprofessional, Multimodal, Family-Centered Quality Improvement Project for Sleep Safety of Hospitalized Infants. Erlick, M., Fioravanti, ID., Yaeger, J., et al.[2021]

References

1. China (Republic : 1949- ) pubmed.ncbi.nlm.nih.gov

The Effects of Kangaroo Care on the Sleep and Wake States of Preterm Infants. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Wahakura Versus Bassinet for Safe Infant Sleep: A Randomized Trial. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Comparative effects of 2 positional supports on neurobehavioral and postural development in preterm neonates. [2007]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Infant Safe Sleep Interventions, 1990-2015: A Review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Modeling of infant safe sleep practice in a newborn nursery: a quality improvement initiative. [2023]

6. China pubmed.ncbi.nlm.nih.gov

[Evidence summary for safety sleep protection strategy in infants]. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

An Interprofessional, Multimodal, Family-Centered Quality Improvement Project for Sleep Safety of Hospitalized Infants. [2021]

8. Germany pubmed.ncbi.nlm.nih.gov

Maternal education and risk factors for sudden death in infants. Working Group of the Groupe Belge de Pédiatres Francophones. [2019]

9. England pubmed.ncbi.nlm.nih.gov

Physiological stability in an indigenous sleep device: a randomised controlled trial. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

Randomized clinical trial of an oscillating air mattress in preterm infants: effect on apnea, growth, and development. [2019]

11. United States pubmed.ncbi.nlm.nih.gov

Early sleep patterns of premature infants are differentially related to later developmental disabilities. [2007]