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Validation of Active-Insights Device to Measure Crying Time

NCT ID: NCT05165589

Last Updated: 2021-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-15

Study Completion Date

2022-04-30

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.

Detailed Description

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Conditions

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Infant Behavior

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Part 1: Initial data collection for device feasibility

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

Group Type EXPERIMENTAL

ActiveInsights accelerometer device

Intervention Type DEVICE

Accelerometer device

Part 2: Device feasibility

10 subjects for 7 days included to evaluate device feasibility

Group Type EXPERIMENTAL

ActiveInsights accelerometer device

Intervention Type DEVICE

Accelerometer device

Interventions

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ActiveInsights accelerometer device

Accelerometer device

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Weeks

Maximum Eligible Age

12 Weeks

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role collaborator

ActivInsights

UNKNOWN

Sponsor Role collaborator

BioGaia AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atlantia Clinical Trials

Cork, , Ireland

Site Status RECRUITING

Countries

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Ireland

Central Contacts

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Gianfranco Grompone, PhD

Role: CONTACT

Phone: +46700019394

Email: [email protected]

Other Identifiers

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CSUB0201

Identifier Type: -

Identifier Source: org_study_id