NCT04301453

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Columbia University · Academic / Other
• Sex: All
• Age: 30 Weeks – 36 Weeks
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-10-30
• Primary completion: 2021-05-27
• Completion: 2021-05-27
• First posted: 2020-03-10
• Last updated: 2022-08-26

Locations

1 site across 1 country: United States