The Effect of Maternal Scent on Sleep Wake States

Columbia University

Status: Completed

Conditions: Development, Infant

Treatments: Other: Maternal Scent

Study type: Interventional

Funder types: Other

Identifiers

NCT04301453

AAAS5200

Details and patient eligibility

About

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.

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 30 to 36 weeks old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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78 participants in 2 patient groups

Maternal Scent Group

Experimental group

Description:

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.

Treatment:

Other: Maternal Scent

Control Group

No Intervention group

Description:

Infants in this group will receive standard of care.