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 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.
Conditions:
🦠 Prematurity 🦠 Very Preterm Maturity of Infant
🗓️ Study Start (Actual) 16 March 2023
🗓️ Primary Completion (Estimated) May 2024
✅ Study Completion (Estimated) June 2024
👥 Enrollment (Estimated) 50
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 New York, New York, United States

📋 Eligibility Criteria

Description

    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.
Ages Eligible for Study: 1 Week to 12 Weeks (CHILD)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 25 January 2023
  • First Submitted that Met QC Criteria 25 January 2023
  • First Posted 3 February 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 September 2023
  • Last Update Posted 6 September 2023
  • Last Verified September 2023