Validation of Active-Insights Device to Measure Crying Time

Pilot & Exploratory - Validation of Active-Insights Device to Measure Crying Time

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.

Study Overview

• Status: Recruiting
• Conditions: Infant Behavior
• Intervention / Treatment: Device: ActiveInsights accelerometer device

• Study Type: Interventional
• Enrollment (Anticipated): 13
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gianfranco Grompone, PhD; Phone Number: +46700019394; Email: gg@biogaia.se

Study Locations

• Ireland
  • Cork, Ireland
    • Recruiting
    • Atlantia Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 weeks to 2 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Aged between 4-12 weeks at screening.
2. Gestational age 37 weeks - 41 weeks at birth.
3. 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.
4. Infant has excessive crying, defined as 3 or more hours per day, during 3 or more days in the preceding week.
5. No birth trauma and nonsyndromic.
6. Readiness and the opportunity for parents/caregivers to fill out a study diary, questionnaires and for infant to wear device.
7. Parent/caregiver with ability to understand and comply with the requirements of the study, as judged by the Investigator.
8. Parent/caregiver willing and able to give informed consent for their and their infant's participation in the study.
9. Infant is considered healthy, following physical exam.

Exclusion Criteria:

1. 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).
2. Premature infants (<35 weeks gestation at birth).
3. Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, formula-fed infants, and those with liver disease.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Part 1: Initial data collection for device feasibility; 3 subjects for 4 days included to collect initial data for algoritm development for device feasibility	Device: ActiveInsights accelerometer device; Accelerometer device
Experimental: Part 2: Device feasibility; 10 subjects for 7 days included to evaluate device feasibility	Device: ActiveInsights accelerometer device; Accelerometer device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device feasibility: Comparison of device-generated versus diary-reported crying time data	Part 2: Comparison of daily crying time data generated by accelerometer and machine-learning versus crying time data reported by parental Barrs diary	7 days
Device feasibility: Comparison of device-generated versus diary-reported fussing time data	Part 2: Comparison of daily fussing time data generated by accelerometer and machine-learning versus fussing time data reported by parental Barrs diary	7 days
Device feasibility: Comparison of device-generated versus diary-reported sleeping time data	Part 2: Comparison of daily sleeping time data generated by accelerometer and machine-learning versus sleeping time data reported by parental Barrs diary	7 days

Collaborators and Investigators

• Sponsor: BioGaia AB
• Collaborators: Atlantia Food Clinical Trials; ActivInsights

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): April 1, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: December 14, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): December 21, 2021
• Last Update Submitted That Met QC Criteria: December 14, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: CSUB0201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No