Validation of Active-Insights Device to Measure Crying Time

BioGaia

Status: Unknown

Conditions: Infant Behavior

Treatments: Device: ActiveInsights accelerometer device

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT05165589

CSUB0201

Details and patient eligibility

About

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.

Enrollment: 13 estimated patients

Sex: All

Ages: 4 to 12 weeks old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 2 patient groups

Part 1: Initial data collection for device feasibility

Experimental group

Description:

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

Treatment:

Device: ActiveInsights accelerometer device

Part 2: Device feasibility

Experimental group

Description:

10 subjects for 7 days included to evaluate device feasibility

Treatment:

Device: ActiveInsights accelerometer device