N/A Completed N=20 Other

A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing

Healthy

Source: ClinicalTrials.gov NCT03729960 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jul 2020

Primary outcomePrimary: The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App. — 3; 1; 3; 6 Participants

Summary

Primary: The rating by the primary caregivers on the use and relevance of data provided by the Language ENvironment Analysis (LENA) recorder and their level of engagement due to the content on the Cool mobile app. Secondary: The rating by the Healthcare Professionals (HCPs) on the use and relevance of data provided by the LENA recorder in their general practice Exploratory * Total crying and fussing time captured by the LENA recorder * Crying and fussing time perceived by the parents * Vital parameters like heart rate, sleep recorded by the Fitbit used by the primary caregiver during crying and fussing events registered by LENA * Comments and feedback provided by the primary caregiver on the LENA recorder and the Cool mobile app * Comments and feedback provided by the HCP on the LENA recorder and the data provided. * Sleep time recorded by the Cocoon Cam * Crying time recorded by the Cocoon Cam * Crying start and end time recorded by the primary caregiver in the COOL app * Sleep start and end time recorded by the primary caregiver in the COOL app * Comments and feedback provided by the primary caregiver and HCP on the Cocoon Cam and the activity log for infant cry and sleep including push notifications in the Cocoon Cam app * Usage data from the Cocoon Cam app

Outcome Measures

Outcome	Result	p-value
PRIMARY The Rating by the Primary Caregivers on the Use and Relevance of the Cry and Fuss Clock Generated From the LENA Recorder Data and the Rating by the Primary Caregiver on the Level of Engagement Due to the Content on the COOL Mobile App.	3; 1; 3; 6; 7; 0	—
SECONDARY The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice.	0; 0; 6; 6; 8; 0	—

Eligibility Criteria

Inclusion Criteria

Infants aged 2 to 12 months.
Primary caregiver should have reliable access to the internet and a reliable device such as a computer, tablet or smart phone to access the Cool mobile app and able to view the LENA data and complete questionnaires.
Primary caregiver should be adequately skilled comfortable in English to read the content in the Cool mobile app and complete questionnaires.
Primary caregiver takes care of the child more than 50% of the time.

Exclusion Criteria

Primary caregiver who is not adequately skilled comfortable in English language to read the content in the Cool mobile app and complete questionnaires.
Incapability of the primary caregiver to access Cool mobile app through internet.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03729960). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.