Validation of Active-Insights Device to Measure Crying Time

Infant Behavior Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165589
• Other study ID #: CSUB0201
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2021
• Est. completion date: April 2022

Study information

• Verified date: December 2021
• Source: BioGaia AB
• Contact: Gianfranco Grompone, PhD
• Phone: +46700019394
• Email: gg[@]biogaia.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 13
• Est. completion date: April 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 12 Weeks

Eligibility

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.

Related Conditions & MeSH terms

• Infant Behavior

Intervention

Device:
• ActiveInsights accelerometer device
Accelerometer device

Locations

Country	Name	City	State
Ireland	Atlantia Clinical Trials	Cork

Sponsors (3)

Lead Sponsor	Collaborator
BioGaia AB	ActivInsights, Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	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