NCT03169699

Brief Summary

To develop and validate a library of cough spectrum from a target of 1000 cough acoustics. Coughs arising from upper respiratory infection, lower chest infections, asthma, allergic conditions are included in the study. Cough acoustic in absence of respiratory disease is also included. This is a prospective observation cohort study recruiting children below the age of 16 years old in 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) Well patients without active coughing.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 25, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 30, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

June 1, 2017

Status Verified

May 1, 2017

Enrollment Period

1.2 years

First QC Date

May 25, 2017

Last Update Submit

May 30, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Acute phase acoustic spectrum Analysis

    Acoustic classifiers

    Day 0-7

Secondary Outcomes (1)

  • Recovery or Chronic phase acoustic spectrum analysis

    Day 7-30

Study Arms (2)

Cough Arm

Children age 16 years old and below with cough at presentation - Patients presenting with active or chronic or residual cough

Well Arm

Children age 16 years old and below and Well with no presentation of cough

Eligibility Criteria

AgeUp to 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodProbability Sample
Study Population

This is a prospective observation cohort study will recruit children below the age of 16 years old. There will be 2 arms : (1) Patients with respiratory conditions presenting with cough and (2) well patient without cough.

You may qualify if:

  • Cough arm 1.Children age 16 years old and below with cough at presentation- Patients presenting with active or chronic or residual cough
  • Well arm
  • Children age 16 years old and below and Well with no cough presentation.

You may not qualify if:

  • Children with severe behavioral
  • Droplet isloated cases as determined by protocol of hospital

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KKWCH

Singapore, 229899, Singapore

RECRUITING

Related Publications (1)

  • B T B, Hee HI, Teoh OH, Lee KP, Kapoor S, Herremans D, Chen JM. Asthmatic versus healthy child classification based on cough and vocalised /a:/ sounds. J Acoust Soc Am. 2020 Sep;148(3):EL253. doi: 10.1121/10.0001933.

MeSH Terms

Conditions

CoughCough-Variant AsthmaInfluenza, Human

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsAsthmaBronchial DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus Diseases

Study Officials

  • Hwan Ing Hee, MBBCH BAO

    KK Women's and Children's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hwan Ing Hee, MBBCH BAO

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 25, 2017

First Posted

May 30, 2017

Study Start

February 1, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

June 1, 2017

Record last verified: 2017-05

Locations