CompletedNot Applicable

Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants

United States20 participantsStarted 2023-03-16

Plain-language 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: 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.

Who can participate

Age range

1 Week – 12 Weeks

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent of Quiet Sleep Time During 3-hour Sleep Assessment

Timeframe: At baseline sleep assessment, up to 3 hours

Trial details

NCT IDNCT05711927

SponsorColumbia University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-05-31

Results submitted2025-06-18

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