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Clinical Trial 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.


Clinical Trial Description

Screening Period:

- At screening visit, after parent(s) of potential subjects and/or legal representatives have been informed about the study, they will be requested to sign the informed consent form (ICF) prior to start of the study.

- After successful signing of the informed consent, the investigator will assess the eligibility of the subjects. If the subject meets all the inclusion and none of the exclusion criteria, the primary caregiver will complete a detailed questionnaire on subject's demographics, birth, family, feeding characteristics and primary caregiver's characteristics.

- The primary caregiver will be provided the LENA recorder kit and in case consented for Fitbit, they will be provided with the Fitbit.

- The primary caregiver will need to complete a training period in order to verify subject's primary caregiver's ability to properly connect, operate and upload data using the LENA recorders and uploader.

- As part of the training period, the primary caregiver will do 1-2 hours of recording using the LENA recorder and successfully upload the data into the LENA cloud server through the internet. Once the study coordinator verifies that the upload is successful, the training and feasibility assessment will be considered as complete and the subject will be considered as enrolled.

- The primary caregiver of the enrolled subject will be provided access to the COOL mobile app and the recording period will start.

Enrollment Period:

- During the recording period, the subject will be using the LENA recorder and will complete a daily questionnaire at the end of the each day.

- At the end of 7 days, the site will perform a phone call and the LENA cry and fuss clock generated from the LENA recorder data for the recorded period will be shared with the primary caregiver through the COOL mobile app.

- After viewing the cry and fuss clock, the primary caregiver will need to complete a questionnaire on the use of LENA recorder and the content of the COOL mobile app.

- The primary caregiver will continue using the LENA recorder for the next 7 days. At the end of 14 days, the LENA cry and fuss data for the recorded period will be shared with the primary caregiver and the primary caregiver will need to complete another questionnaire on the use and relevance of the cry and fuss clock and overall relevance of the COOL mobile app.

- At the end of the recording period , the primary caregiver will schedule an appointment with the PI. If the primary caregiver consents for the use of Fitbit, they will be provided Fitbit to record their vital parameters like heart rate and sleep pattern through the 14 days after enrollment.

End of study:

- At the end of study visit, the primary caregiver will discuss the data provided by the LENA recorder and the COOL mobile app with the PI and PI will use the data to explain to the primary care giver if there is any specific cry pattern that could be assessed based on the objective data from LENA.

- The Primary caregiver and PI will complete a questionnaire each on the use of the data provided by the LENA recorder during their discussion. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03729960
Study type Interventional
Source Danone Asia Pacific Holdings Pte, Ltd.
Contact
Status Not yet recruiting
Phase N/A
Start date November 2018
Completion date January 2019

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