Clinical trial NCT04301453: The Effect of Maternal Scent on Sleep Wake States
Official title: The Effect of Maternal Scent on Sleep Wake States, Brain Maturation, and Heart Rate Variability: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Development, Infant
Keywords: Sleep wake cycles
Quiet sleep
Active sleep
Maternal scent
Lead sponsor: Columbia University
Sponsor class: OTHER
First posted: 2020-03-10
Enrollment: 78
Sex: ALL
Minimum age (years): 30
Maximum age (years): 36
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: Inclusion criteria:

* Infants born at 30 weeks gestation to 36 weeks gestation.

Exclusion criteria:

* Infants with congenital anomalies, neonatal abstinence syndrome, or head ultrasound findings of grade II intraventricular hemorrhage or greater.
* Infants participating in studies with similar interventions.

Primary outcomes:
measure: Percentage of time spent in quiet sleep
timeFrame: 2 hours
measure: Percentage of time spent active sleep
timeFrame: 2 hours
Secondary outcomes:
measure: Beta to theta ratio
timeFrame: 2 hours
measure: Number of mothers diagnosed with acute stress disorder based on score on the Stanford Acute Stress Reaction Questionnaire (SASRQ)
timeFrame: 2 hours
Other outcomes:
Locations:
city: New York
country: United States
facility: New York Presbyterian, Columbia University Medical Center
state: New York
Study officials:
affiliation: Columbia University
name: Rakesh Sahni, MD
role: PRINCIPAL_INVESTIGATOR
References: