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NCT Number: NCT07392138

Understanding Newborn-Mother Synchrony at Home: Feasibility of Remote Monitoring

Parents and newborns influence each other in a dynamic interaction that can be described as synchrony. Synchrony between a newborn and mother refers to the dynamic and reciprocal adaptation between the newborn and mother. In this synchrony, the mother is highly receptive and sensitive to the newborn's signals, feelings, and needs. The aim of this study is to investigate the physiological and behavioral synchrony between newborns and their mothers, and to investigate the connection between maternal heart rate variability and postpartum depression symptoms in the home environment and to evaluate the suitability of remote monitoring devices for use in the home environment.

The study participants consist of 30 newborns and 30 mothers. The inclusion criteria for newborns are: 1) informed consent from the newborn's parents/guardians 2) the newborn's health status has been confirmed as normal during hospital monitoring, and 3) the newborn is less than one month old. The inclusion criteria for mothers are: 1) ability to participate in Finnish, and 2) the mother has access to an Android smartphone.

Data collection will be carried out using the following remote monitoring methods: Emfit smart mattress, Zoundream Cry analyses technology, Polar Verity Sense sensor, and Empatica EmbracePlus sensor. In addition, data will be collected using background information forms, a maternal stress scale (PSS-4), a diary completed by the mother, a maternal depression questionnaire (EPDS), and questionnaires measuring the suitability of remote monitoring in the home environment, and a thematic interview. In addition, at the end of the data collection phase, the mothers participating in the study will try out the Companion App, which displays sample data on the well-being of newborns, and respond to a questionnaire on the usability of the app.

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Key information

Conditions

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

, mothers:

  • ability to participate in Finnish
  • Android smart phone available

Inclusion criteria

, newborns:

  • received informed consent from both parents/guardians
  • the newborn's health has been stated normal during hospital stay
  • the newborn is < 1-month of age

Exclusion criteria

, both (mother and newborn):

Not meeting the inclusion criteria

Treatment and study plan

Using monitoring devices

Other

During the data collection, mother and newborn are using the monitoring devices listed in study description.

Primary outcomes

  1. Physiological synchrony

    Time frame: 24 hours

    Measuring correlation between mother heart rate (mHR (unit: BPM)) and heart rate variability (mHRV (unit ms)) and newborn heart rate (bHR (unit: BPM)) and heart rate variability (bHRV (unit: ms)).

Secondary outcomes

  1. Behavioral synchrony

    Time frame: 24 hours

    Measuring the correlation between mother total sleep duration and duration of different sleep stages and newborn total sleep duration and duration of sleep stages (unit: hours and minutes).

  2. Correlation between mother heart rate variability and depressive symptoms

    Time frame: Duration of data collection varies from 1 to 4 weeks depending on the mother's decision.

    Measuring the correlation between mother heart rate variability (mHRV (units: ms)) and depressive symptoms (points from EPDS scale).

  3. Correlation between mother sleep and depressive symptoms.

    Time frame: Duration of data collection varies from 1 to 4 weeks, depending on the mother's decision.

    Measuring the correlation between the duration of mother sleep stages (unit: hours and minutes) and depressive symptoms (points from EPDS scale).

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Axelin, Professor

CONTACT

[email protected]

+358405029905

Sponsors and collaborators

Lead sponsor

University of Turku

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 6, 2026
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.