The Effect of Maternal Scent on Sleep Wake States

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

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.

Study Overview

• Status: Completed
• Conditions: Development, Infant
• Intervention / Treatment: Other: Maternal Scent

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.

• Study Type: Interventional
• Enrollment (Actual): 78
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10032
      • New York Presbyterian, Columbia University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 months to 8 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Maternal Scent Group; 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.	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.
No Intervention: Control Group; Infants in this group will receive standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Columbia University
• Investigators: Principal Investigator: Rakesh Sahni, MD, Columbia University

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Actual): May 27, 2021
• Study Completion (Actual): May 27, 2021

Study Registration Dates

• First Submitted: March 6, 2020
• First Submitted That Met QC Criteria: March 6, 2020
• First Posted (Actual): March 10, 2020

Study Record Updates

• Last Update Posted (Actual): August 26, 2022
• Last Update Submitted That Met QC Criteria: August 25, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Sleep wake cycles; Quiet sleep; Active sleep; Maternal scent
• Other Study ID Numbers: AAAS5200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No