NCT03729960: COOL

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

Completed NA Results posted Last updated 8 July 2020

What this trial tests

NA trial testing LENA recorder in Healthy in 20 participants. Completed in 17 September 2019.

Timeline

20 November 2018

Primary endpoint
17 September 2019

17 September 2019

Quick facts

Lead sponsor	Danone Asia Pacific Holdings Pte, Ltd.
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	other
Enrollment	20
Start date	20 November 2018
Primary completion	17 September 2019
Estimated completion	17 September 2019
Sites	1 location across Singapore

Drugs / interventions tested

• LENA recorder

Conditions studied

• Healthy — all drugs for Healthy →

Sponsor

Danone Asia Pacific Holdings Pte, Ltd.

Who can join

Adults 2 Months to 12 Months, any sex, with Healthy. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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. Primary · 2 weeks

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)

Use and relevance scale 0 - Not at all

Group	Value	95% CI
LENA	3

Use and relevance Scale 1

Group	Value	95% CI
LENA	1

Use and relevance Scale 2

Group	Value	95% CI
LENA	3

Use and relevance Scale 3

Group	Value	95% CI
LENA	6

Use and relevance Scale 4

Group	Value	95% CI
LENA	7

Use and relevance Scale 5 - Yes, very much

Group	Value	95% CI
LENA	0

The Rating by the HCPs on the Use and Relevance of Data Provided by the LENA Recorder in Their General Practice. Secondary · 2 weeks

Rating by the HCP about the use and relevance of the LENA data in general practice using 6 point scale \[0=Not at all, 5=Yes, very much\], Scale 1 to 4 is subjective to user definition (not defined specifically)

Group	Value	95% CI
LENA	0
LENA	0
LENA	6
LENA	6

Exploratory Parameter :Total Crying and Fussing Time Captured by the LENA Recorder Secondary · 2 weeks

Exploratory Parameter : Total daily crying and fussing time captured by the LENA recorder in minutes

Group	Value	95% CI
LENA	19.6	± 30.7

Exploratory Parameter :Crying and Fussing Time Perceived by the Parents Secondary · 2 weeks

Daily duration of cry and/or fuss in the scale of : \<30 mins 30 mins to 1hr \>1hr to 3hrs \> 3hrs

< 30 mins

Group	Value	95% CI
LENA	105

30 mins to 1hr

Group	Value	95% CI
LENA	86

>1hr to 3hrs

Group	Value	95% CI
LENA	82

>3hrs

Group	Value	95% CI
LENA	16

Missing

Group	Value	95% CI
LENA	11

Usage Time of the Cocoon Cam App by the Primary Caregiver Secondary · 2 weeks

Usage time (in minutes) of the Cocoon Cam app by the primary caregiver.

Group	Value	95% CI
LENA	4.1	0 – 14.4

To Explore the Usability of Cocoon Cam and Data Captured by the Cocoon Cam App for the HCP in Their Daily Practice Secondary · 2 weeks

To explore the usability of Cocoon Cam and data captured by the Cocoon Cam app for the HCP in their daily practice. Scale 0 = Not at all, Scale 5 = Yes very much. Scale 1 to 4 is subjective to user definition (not defined specifically)

Group	Value	95% CI
LENA	1
LENA	0
LENA	2
LENA	2

Sponsor's own description

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

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.