Clinical trial NCT05165589: Validation of Active-Insights Device to Measure Crying Time
Official title: Pilot & Exploratory - Validation of Active-Insights Device to Measure Crying Time
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Infant Behavior
Lead sponsor: BioGaia AB
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
name: ActivInsights
First posted: 2021-12-21
Enrollment: 13
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention 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
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data
timeFrame: 4 days
measure: Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data
timeFrame: 7 days
Secondary outcomes:
measure: Device feasibility: Comparison of device-generated versus diary-reported crying time data
timeFrame: 7 days
measure: Device feasibility: Comparison of device-generated versus diary-reported fussing time data
timeFrame: 7 days
measure: Device feasibility: Comparison of device-generated versus diary-reported sleeping time data
timeFrame: 7 days
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: Atlantia Clinical Trials
Study officials:
References: