Infant BehaviorNCT05165589
Validation of Active-Insights Device to Measure Crying Time
A study testing ActiveInsights accelerometer device in people with Infant Behavior, run by BioGaia AB at 1 site in Ireland.
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. Read more about this study
- Who is it for?
- Ages 4 to 12 weeksHealthy volunteers can take part
- Conditions the study is for
- Infant Behavior
- What is being tested?
- ActiveInsights accelerometer device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteIreland
- Study dates
- 15 Oct 2021to Apr 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged between 4-12 weeks at screening.
- Gestational age 37 weeks - 41 weeks at birth.
- 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.
- Infant has excessive crying, defined as 3 or more hours per day, during 3 or more days in the preceding week.
- No birth trauma and nonsyndromic.
- Readiness and the opportunity for parents/caregivers to fill out a study diary, questionnaires and for infant to wear device.
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- Parent/caregiver with ability to understand and comply with the requirements of the study, as judged by the Investigator.
- Parent/caregiver willing and able to give informed consent for their and their infant's participation in the study.
- Infant is considered healthy, following physical exam.
Who cannot join
- 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).
- Premature infants (<35 weeks gestation at birth).
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, formula-fed infants, and those with liver disease.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot & Exploratory - Validation of Active-Insights Device to Measure Crying Time
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.
- Conditions
- Infant Behavior
- Being tested
- ActiveInsights accelerometer device
- Medical subject headings
- Infant Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ActiveInsights accelerometer deviceDevice
Accelerometer device
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Initial data collection for device feasibility | Experimental | 3 subjects for 4 days included to collect initial data for algoritm development for device feasibility Receives: Device: ActiveInsights accelerometer device |
| Part 2: Device feasibility | Experimental | 10 subjects for 7 days included to evaluate device feasibility Receives: Device: ActiveInsights accelerometer device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 days
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
Measured: 7 days
Secondary outcomes (3)
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
Measured: 7 days
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
Measured: 7 days
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
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start15 Oct 2021
- Primary completionJan 2022 (estimated)
- Study completionApr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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
- Masking
- None (open label)
- Enrolment
- 13 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioGaia AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, ActivInsights
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165589
- Sponsor's protocol ID
- CSUB0201
- Status last verified
- Dec 2021
- First submitted
- 15 Oct 2021
- Last updated
- 21 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot & Exploratory - Validation of Active-Insights Device to Measure Crying Time
- ClinicalTrials.gov ID
- NCT05165589
- Acronym / sponsor ID
- CSUB0201
- Conditions
- Infant Behavior
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 13 participants (estimated)
- Lead sponsor
- BioGaia ABIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials, ActivInsights
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Apr 2022 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| Part 1: Initial data collection for device feasibility | Experimental | Device: ActiveInsights accelerometer device3 subjects for 4 days included to collect initial data for algoritm development for device feasibility |
| Part 2: Device feasibility | Experimental | Device: ActiveInsights accelerometer device10 subjects for 7 days included to evaluate device feasibility |
Who may qualify
- Ages
- 4 to 12 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Aged between 4-12 weeks at screening.
- Gestational age 37 weeks - 41 weeks at birth.
- 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.
- Infant has excessive crying, defined as 3 or more hours per day, during 3 or more days in the preceding week.
- No birth trauma and nonsyndromic.
Key exclusion criteria (3 listed)
- 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).
- Premature infants (<35 weeks gestation at birth).
- Infants with congenital heart disease, immunodeficiency, asplenia, cancer, cystic fibrosis, formula-fed infants, and those with liver disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ActiveInsights accelerometer deviceAccelerometer device | Device | Part 1: Initial data collection for device feasibility, Part 2: Device feasibility |
Primary outcome
Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data
Time frame: 4 days
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
Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data
Time frame: 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
3 secondary outcomes
Device feasibility: Comparison of device-generated versus diary-reported crying time data
Time frame: 7 days
Device feasibility: Comparison of device-generated versus diary-reported fussing time data
Time frame: 7 days
Device feasibility: Comparison of device-generated versus diary-reported sleeping time data
Time frame: 7 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ActiveInsights accelerometer device in people with Infant Behavior, run by BioGaia AB at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gianfranco Grompone, PhD (+46700019394, gg@biogaia.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Device feasibility: Comparison of device-generated versus diary-reported crying and fussing time data (time frame: 4 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2021.