Validation of Active-Insights Device to Measure Crying Time

Study Overview
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Brief Summary
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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.

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

Conditions
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Infant Behavior

Intervention / Treatment
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* Device: ActiveInsights accelerometer device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 4 Weeks
Maximum Age: 12 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 |