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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines whether a SNOO Smart Sleeper bassinet improves sleep and stabilizes vital signs, such as heart rate and oxygen levels, in premature infants. Babies will spend time in both an active SNOO, which moves and plays white noise, and an inactive SNOO, resembling a traditional bassinet. The trial targets premature infants in the hospital who breathe independently without extra oxygen support and have no major brain or spinal issues. Participants may experience more restful sleep during the trial. As an unphased trial, it offers parents a unique chance to contribute to research that could enhance sleep and health outcomes for premature infants.

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 prior data suggests that the SNOO Smart Sleeper is safe for premature infants?

Research shows that the SNOO Smart Sleeper bassinet is generally well-received by babies. Studies have found that babies using the SNOO tend to sleep longer and cry less, suggesting it might help them stay calm and well-rested.

The SNOO is designed to create a safe sleeping space, which is important for reducing risks linked to infant sleep. Previous research suggests that the SNOO can calm babies as effectively as parents.

Although specific safety data from clinical trials is lacking, the positive effects on sleep and crying are encouraging. Overall, based on available studies, the SNOO appears to be a safe choice for improving sleep in babies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The SNOO Smart Sleeper is unique because it offers a high-tech approach to helping premature infants sleep better, potentially improving their overall development. Unlike traditional bassinets, the SNOO uses a combination of gentle rocking motions and white noise to mimic the soothing environment of the womb, which may help calm infants and promote longer, more restful sleep. Researchers are excited about this trial because it could demonstrate a new way to support the health and growth of premature babies, offering an innovative alternative to standard infant care methods.

What evidence suggests that the SNOO Smart Sleeper is effective for improving sleep and vital signs in premature infants?

Research shows that the SNOO Smart Sleeper bassinet can calm babies similarly to a parent's soothing. Babies using the SNOO tend to sleep better and wake up less often. One study found that babies in the SNOO wake up one less time per night. In this trial, participants in the SNOO group will use the SNOO Smart Sleeper according to the manufacturer's instructions, while the traditional bassinet group will use a powered-off SNOO to mimic traditional conditions. Parents and nurses report that the SNOO helps calm babies. These findings suggest the SNOO might help preterm babies sleep more peacefully and possibly improve their vital signs. ^{1 2 3 6 7}

Who Is on the Research Team?

Rakesh Sahni, MD

Principal Investigator

Columbia University

Are You a Good Fit for This Trial?

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

My weight is between 1.8 kg and 11.3 kg.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10371059/

The Experiences and Perceptions of Neonatal Clinicians ... Prior research has reported that the SNOO is equally as effective at soothing infants as parents.15 Respondents in this study also agreed the SNOO helped nurses ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10485641/

The five “S's” and the “SNOO” Smart Sleeper—non- ... The results are promising: babies and parents sleep meaningfully better and crying also decreases significantly. 'Parents are often so satisfied with the crib, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1355184123000455

A descriptive evaluation of time savings and work ... SNOO has been found to be equally effective at eliciting a calming response in infants when compared to parent soothing (Möller et al., 2019). An analysis of ...

5. journals.lww.com journals.lww.com/advancesinneonatalcare/fulltext/2023/08000/the_experiences_and_perceptions_of_neonatal.15.aspx

The Experiences and Perceptions of Neonatal Clinicians ... Data have also shown that infants in the SNOO average one less waking per night when compared with the normative infant sleep (1.09 ± 0.89 vs 1.89 ± 1.10).18.

6. withpower.com withpower.com/trial/phase-premature-birth-1-2023-8d455

SNOO Smart Sleeper 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 ...

7. tp.amegroups.org tp.amegroups.org/article/view/116476/html

The five “S's” and the “SNOO” Smart Sleeper—non ... The 2 studies reviewed suggested that the SNOO was helpful in reducing crying and improving the sleep duration of normal infants. Further studies have suggested ...