CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 20 enrolled
Drug / intervention
LENA recorderother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03729960
NCT03729960N/ACompleted

Cry Management and Awareness Tool (Cool): A Proof of Concept Study to Investigate the Use and Relevance of a Digital Platform for Infant Crying and Fussing

Danone Asia Pacific Holdings Pte, Ltd.·interventional·Posted Nov 5, 2018·Updated Jul 8, 2020

In Brief

A clinical study evaluating LENA recorder for Healthy. Completed, enrolled 20 participants across 1 site.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSingapore
CollaboratorsTech Observer

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedNov 5, 2018
Enrollment StartNov 20, 2018
Primary CompletionSep 17, 2019
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 7.7 years ago

Interventions

LENA recorderother

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