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

NCT03729960 | Completed Results

• 1 other identifier: EBB17GC16811_2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• 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.

  Rating by the primary caregiver about the usability and relevance using a 6-point scale \[0=Not at all, 5=Yes, very much\]; Scale 1 to 4 is subjective to user definition (not defined specifically)

  2 weeks

Secondary Outcomes (1)

• The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice.

  2 weeks

Other Outcomes (4)

• Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder

  2 weeks

• Exploratory Parameter :Crying and Fussing Time Perceived by the Parents

  2 weeks

• Usage Time of the Cocoon Cam App by the Primary Caregiver

  2 weeks

Study Arms (1)

LENA

OTHER

Lena device with Fitbit and Cocooncam being optional

Other: LENA recorder

Interventions

LENA recorder OTHER

The LENA recorder model# 0121 is a lightweight, pocket-size, rechargeable electronic recorder together with a mobile application to view the data and answer questionnaires

Also known as: Fitbit, Cool Mobile app,Cocoon Cam

LENA

Eligibility Criteria

• Age: 2 Months - 12 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Danone Asia Pacific Holdings Pte, Ltd.: lead
• Tech Observer: collaborator

Study Sites (1)

SBCC Clinic Pte Ltd

Singapore, Singapore

Location

Results Point of Contact

• Title: Digital Project Manager
• Organization: Danone Asia Pacific Holdings

jill.wong@danone.com

82281172

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2018
• First Posted: November 5, 2018
• Study Start: November 20, 2018
• Primary Completion: September 17, 2019
• Study Completion: September 17, 2019
• Last Updated: July 8, 2020
• Results First Posted: July 8, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)