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

NCT03729960 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2020-07-08

Study results available
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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

Interventions

OTHER

LENA recorder

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

Sponsors & Collaborators

  • Tech Observer

    collaborator INDUSTRY

  • Danone Asia Pacific Holdings Pte, Ltd.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
2 Months
Max Age
12 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-20
Primary Completion
2019-09-17
Completion
2019-09-17

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03729960 on ClinicalTrials.gov