Validation of Active-Insights Device to Measure Crying Time

NCT05165589 | Unknown

• 1 other identifier: CSUB0201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the ability of a machine learning algorithm to accurately detect fussing and crying time in infants using accelerometery data collected from a wearable device, compared to the Barr's parent-/caregiver-completed behaviour diary.

Conditions

Infant Behavior

Outcome Measures

Primary Outcomes (2)

• Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data

  Part 1: Comparison of daily crying and fussing time data generated by accelerometer and machine-learning versus crying and fussing time data reported by parental Barrs diary

  4 days

• Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data

  Part 2: Comparison of daily crying and fussing time data generated by accelerometer and machine-learning versus crying and fussing time data reported by parental Barrs diary

  7 days

Secondary Outcomes (3)

• Device feasibility: Comparison of device-generated versus diary-reported crying time data

  7 days

• Device feasibility: Comparison of device-generated versus diary-reported fussing time data

  7 days

• Device feasibility: Comparison of device-generated versus diary-reported sleeping time data

  7 days

Study Arms (2)

Part 1: Initial data collection for device feasibility

EXPERIMENTAL

3 subjects for 4 days included to collect initial data for algoritm development for device feasibility

Device: ActiveInsights accelerometer device

Part 2: Device feasibility

EXPERIMENTAL

10 subjects for 7 days included to evaluate device feasibility

Device: ActiveInsights accelerometer device

Interventions

ActiveInsights accelerometer device DEVICE

Accelerometer device

Part 1: Initial data collection for device feasibility; Part 2: Device feasibility

Eligibility Criteria

• Age: 4 Weeks - 12 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Aged between 4-12 weeks at screening.
• Gestational age 37 weeks - 41 weeks at birth.
• Birth weight appropriate for gestational age (AGA - weight between 10th and 90th percentile) or Large for Gestational Age (LGA - weight above the 90th percentile) determined using WHO Weight-for Age percentile guides.
• Infant has excessive crying, defined as 3 or more hours per day, during 3 or more days in the preceding week.
• No birth trauma and nonsyndromic.
• Readiness and the opportunity for parents/caregivers to fill out a study diary, questionnaires and for infant to wear device.
• Parent/caregiver with ability to understand and comply with the requirements of the study, as judged by the Investigator.
• Parent/caregiver willing and able to give informed consent for their and their infant's participation in the study.
• Infant is considered healthy, following physical exam.

You may not qualify if:

• Infants with failure to thrive, intrauterine growth retardation, haematochezia (blood in the stools), diarrhoea (watery stools that takes the shape of a container \> 12x in breastfed and \>5 in partially breastfed infants daily), or fever (38.0 degrees).
• Premature infants (\<35 weeks gestation at birth).
• Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, formula-fed infants, and those with liver disease.

Sponsors & Collaborators

• BioGaia AB: lead
• Atlantia Food Clinical Trials: collaborator
• ActivInsights: collaborator

Study Sites (1)

Atlantia Clinical Trials

Cork, Ireland

RECRUITING

MeSH Terms

Conditions

Infant Behavior

Condition Hierarchy (Ancestors)

Child Behavior; Behavior

Central Study Contacts

Gianfranco Grompone, PhD

CONTACT

+46700019394; gg@biogaia.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Part 1: 3 subjects for 4 days included to collect initial data for algoritm development for device feasibility evaluation Part 2: 10 subjects for 7 days included to evaluate device feasibility

Study Record Dates

• First Submitted: October 15, 2021
• First Posted: December 21, 2021
• Study Start: October 15, 2021
• Primary Completion: January 1, 2022
• Study Completion: April 1, 2022
• Last Updated: December 21, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)