The Effect of Maternal Scent on Sleep Wake States

NCT ID: NCT04301453

Last Updated: 2022-08-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 78 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-30
• Study Completion Date: 2021-05-27

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.

Conditions

Development, Infant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Maternal Scent

Intervention Type: OTHER

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

Control Group

Infants in this group will receive standard of care.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 30 Weeks
• Maximum Eligible Age: 36 Weeks
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Columbia University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rakesh Sahni, MD

Role: PRINCIPAL_INVESTIGATOR

Columbia University

Locations

New York Presbyterian, Columbia University Medical Center

New York, New York, United States

Countries

United States

Other Identifiers

AAAS5200

Identifier Type: -

Identifier Source: org_study_id