The Effect of Maternal Scent on Sleep Wake States

Development, Infant Clinical Trial

Official title:

The Effect of Maternal Scent on Sleep Wake States, Brain Maturation, and Heart Rate Variability: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04301453
• Other study ID #: AAAS5200
• Status: Completed
• Phase: N/A
• Start date: October 30, 2019
• Est. completion date: May 27, 2021

Study information

• Verified date: August 2022
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 78
• Est. completion date: May 27, 2021
• Est. primary completion date: May 27, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Weeks to 36 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Development, Infant

Intervention

Other:
• Maternal Scent
Mothers will wear a breast pad during their visit. The breast pad will be placed in the hats of infants for 24 hours.

Locations

Country	Name	City	State
United States	New York Presbyterian, Columbia University Medical Center	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time spent in quiet sleep	Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in quiet sleep.	2 hours
Primary	Percentage of time spent active sleep	Active sleep, quiet sleep, and indeterminate sleep will be behaviorally coded to determine the total amount of time spent in active sleep.	2 hours
Secondary	Beta to theta ratio	EEG data will be analyzed to determine the beta to theta ratio in order to assess sleep wake cycling.	2 hours
Secondary	Number of mothers diagnosed with acute stress disorder based on score on the Stanford Acute Stress Reaction Questionnaire (SASRQ)	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.	2 hours