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NCT05711927
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
Conditions: Prematurity, Very Preterm Maturity of Infant
Sex: All
Ages: 1 Week – 12 Weeks
Healthy volunteers: 1
Phase: NA
Enrollment: 50
Sponsor: Columbia University
Location: United States
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:Do preterm infants who sleep in the SNOO have more quiet sleep?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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT05711927). StuddyBuddy aggregates publicly available trial information.