Prematurity Clinical Trial
Official title:
The Effect of Sleeping Environment on Sleep-Wake Organization in Preterm Infants
NCT number | NCT05711927 |
Other study ID # | AAAU2315 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | March 16, 2023 |
Est. completion date | June 2024 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2024 |
Est. primary completion date | May 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Week to 12 Weeks |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | Morgan Stanley Children's Hospital Neonatal Intensive Care Unit, NewYork Presbyterian | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Columbia University | Happiest Baby, Inc. |
United States,
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Dereymaeker A, Pillay K, Vervisch J, De Vos M, Van Huffel S, Jansen K, Naulaers G. Review of sleep-EEG in preterm and term neonates. Early Hum Dev. 2017 Oct;113:87-103. doi: 10.1016/j.earlhumdev.2017.07.003. Epub 2017 Jul 12. — View Citation
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* Note: There are 13 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in amount of quiet sleep time | Quiet sleep is a marker of sleep maturation and will be measured by the researcher during the 3-hour-long sleep assessments. Quiet sleep defined as eyes closed with predominantly flaccid "rag doll" appearance, body movements limited to startles, and rhythmic jaw jerks lasting 1 to 2 seconds. | 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) | |
Secondary | Change in heart rate variability | Heart rate variability is the fluctuation of beat-to-beat heart rate intervals over time and is a marker of autonomic nervous system maturation. | 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) | |
Secondary | Change in cerebral oxygenation | Cerebral oxygenation is a measure of the oxygen content of brain and will be measured by near-infrared spectroscopy (NIRS). | 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) | |
Secondary | Change in oxygen saturation | Oxygen saturation is a measure of the oxygen content of the blood, as measured by pulse oximetry. | 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) | |
Secondary | Change in intermittent hypoxemic event frequency | Intermittent hypoxemic events are episodes where oxygen saturation is low for prolonged periods, as measured by pulse oximetry. | 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) |
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