Validation of Active-Insights Device to Measure Crying Time

Not Applicable

• Conditions: Infant Behavior
• Interventions: Device: ActiveInsights accelerometer device

• Registration Number: NCT05165589
• Lead Sponsor: BioGaia AB

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-10-15
• Study First Submitted: 2021-10-15
• Status Verified: 2021-12
• Study First Submitted QC: 2021-12-14
• Last Update Submitted: 2021-12-14
• Study First Posted: 2021-12-21
• Last Update Posted: 2021-12-21
• Primary Completion: 2022-01
• Study Completion: 2022-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Part 1: Initial data collection for device feasibility	ActiveInsights accelerometer device	3 subjects for 4 days included to collect initial data for algoritm development for device feasibility
Part 2: Device feasibility	ActiveInsights accelerometer device	10 subjects for 7 days included to evaluate device feasibility

Primary Outcome Measures

Name	Time	Method
Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data	7 days	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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Atlantia Clinical Trials; 🇮🇪 Cork, Ireland