N/A
Completed N=20
Sleep in SNOO Smart Sleeper Bassinet in Preterm Infants
prematurity · Very Preterm Maturity of Infant
Source: ClinicalTrials.gov NCT05711927 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Sep 2025
Primary outcomePrimary: Percent of Quiet Sleep Time During 3-hour Sleep Assessment — 26.8; 19.8 percent
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent of Quiet Sleep Time During 3-hour Sleep Assessment |
26.8; 19.8 | — |
| SECONDARY Change in Heart Rate Variability |
— | — |
| SECONDARY Change in Cerebral Oxygenation |
— | — |
| SECONDARY Change in Oxygen Saturation |
— | — |
| SECONDARY Change in Intermittent Hypoxemic Event Frequency |
— | — |
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.
Data sourced from ClinicalTrials.gov (NCT05711927). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.