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Behavioural Intervention
SNOO Smart Sleeper for Premature Infants
N/A
Recruiting
Led By Rakesh Sahni, MD
Research Sponsored by Columbia University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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)
Awards & highlights
Study Summary
This trial assesses if premature infants sleep better & have better vital signs when sleeping in a SNOO bassinet that moves & plays white noise.
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects may include more restful sleep and improved vital signs during the assessments when using the SNOO Smart Sleeper compared to traditional bassinets.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 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)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in amount of quiet sleep time
Secondary outcome measures
Change in cerebral oxygenation
Change in heart rate variability
Change in intermittent hypoxemic event frequency
+1 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: SNOO groupExperimental Treatment1 Intervention
The SNOO Smart Sleeper will be used in accordance with the manufacturer's programming and instructions.
Group II: Traditional bassinet groupPlacebo Group1 Intervention
The SNOO will remain powered off to mimic the conditions of sleeping in a traditional hospital bassinet.
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Who is running the clinical trial?
Happiest Baby, Inc.Industry Sponsor
2 Previous Clinical Trials
1,110 Total Patients Enrolled
Columbia UniversityLead Sponsor
1,433 Previous Clinical Trials
2,447,209 Total Patients Enrolled
Rakesh Sahni, MDPrincipal InvestigatorColumbia University
1 Previous Clinical Trials
78 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a genetic condition that affects my brain function.I have airway problems that might cause sleep issues.I have had a brain bleed.I have severe brain function problems.I have a bleeding disorder.I have had surgery or a minor procedure like hernia repair.I have not taken any sedatives in the last 24 hours.I can roll over to my hands and knees by myself.My baby was born between 28 and 36 weeks of pregnancy.My weight is between 1.8 kg and 11.3 kg.I can breathe on my own without needing extra oxygen.My baby is older than 35 weeks in postmenstrual age.
Research Study Groups:
This trial has the following groups:- Group 1: SNOO group
- Group 2: Traditional bassinet group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there still spaces available to join this research endeavor?
"As indicated on clinicaltrials.gov, this investigational research is no longer recruiting participants. The trial was initially posted on February 1st 2023 and the details were last updated 25 days ago. Nevertheless, there are still 263 other trials inviting patient enrolment right now."
Answered by AI
Would elderly adults be eligible for selection in this experiment?
"As per the detailed requirements, eligible participants must be between 1 week and 12 weeks old. Additionally, there are 192 trials for subjects below 18 years of age and 76 studies dedicated to individuals over 65 years old."
Answered by AI
Does this trial have specific requirements for eligibility?
"This clinical trial is admitting 50 infants that are at most 12 weeks old and preterm. To qualify, the newborn must be a singleton gestation with a gestational age of 28w0d to 36w6d at birth as well as have an appropriate postmenstrual age, weight range (1.8 - 11.3 kg), stable temperature, no respiratory aids needed for room air breathing, normal head ultrasound results (if acquired) and be admitted in the NICU ward of Morgan Stanley Children's Hospital."
Answered by AI
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