The Effect of Maternal Scent on Sleep Wake States
- Conditions
- Development, Infant
- Interventions
- Other: Maternal Scent
- Registration Number
- NCT04301453
- Lead Sponsor
- Columbia University
- Brief Summary
This study will be a prospective, randomized controlled study, which aims to determine if a maternal scent intervention improves the sleep wake states, brain maturation, and heart rate variability in premature infants admitted to the neonatal intensive care unit (NICU). Infants will be randomized to either 24 hours of exposure to maternal scent or standard of care. Sleep wake states will be obtained using behavioral coding. Brain maturation will be measured using several electroencephalogram (EEG) parameters. Heart rate variability will be collected as part of vital sign collection.
- Detailed Description
Sleep is important for the growth and development of infants. There are different states that make up sleep wake cycles including quiet sleep, active sleep, and transitional sleep. The amount of time that infants spend in quiet sleep increases as they mature. There are different tools that can be used to measure sleep state including EEG, behavior, and vital signs. Recent research has looked at ways to improve sleep in infants admitted to the NICU including music and maternal voice. The investigators are interested in studying maternal scent. Maternal scent has been shown to improve infant feeding and to reduce infant crying during painful procedures. Therefore, the investigators are interested in studying how maternal scent might affect sleep wake state in infants admitted to the NICU. The investigators will observe infant behavior and use EEG and vital signs to assess sleep state in infant after they are exposed to maternal scent.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 78
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Maternal Scent Group Maternal Scent Infants in this group will be exposed to a breast pad worn by their mothers to extract maternal scent. This exposure will last 24 hours.
- Primary Outcome Measures
Name Time Method Percentage of time spent in quiet sleep 2 hours Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in quiet sleep.
Percentage of time spent active sleep 2 hours Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in active sleep.
- Secondary Outcome Measures
Name Time Method Beta to theta ratio 2 hours EEG data will be analyzed to determine the beta to theta ratio in order to assess sleep wake cycling.
Number of mothers diagnosed with acute stress disorder based on score on the Stanford Acute Stress Reaction Questionnaire (SASRQ) 2 hours The SASRQ questionnaire is used to assess symptoms of stress after a difficult event. There are four sub-scales including 1) Dissociative Symptoms 2) Re-Experiencing 3) Avoidance and 4) Increased Anxiety. These sub-scales are scored to determine if the diagnosis of acute stress disorder can be made. A symptom is scored as present if the respondent marks it as occurring at least "sometimes," which includes a response of 3, 4 or 5 on the 0-5 scale. A diagnosis of Acute Stress Disorder requires at least 3 symptoms out of the five types of dissociative symptoms, 1 reexperiencing symptom, 1 avoidance symptom, and 1 marked anxiety/increased arousal symptom. In order to count a symptom as present, circled response must be 3 or higher.
Trial Locations
- Locations (1)
New York Presbyterian, Columbia University Medical Center
🇺🇸New York, New York, United States