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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04301453
Other study ID # AAAS5200
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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