NCT03187067

Brief Summary

The purpose of this study is to evaluate the impact of LUS on the diagnosis and management of childhood pneumonia in developing countries

Trial Health

90
On Track

Trial Health Score

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

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2017

Geographic Reach
2 countries

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 12, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 31, 2017

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 8, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 8, 2019

Completed
Last Updated

April 8, 2019

Status Verified

April 1, 2019

Enrollment Period

1.4 years

First QC Date

June 12, 2017

Last Update Submit

April 5, 2019

Conditions

PneumoniaAcute Respiratory Infection

Keywords

pneumoniadiagnosticultrasoundPakistanMozambique

Outcome Measures

Primary Outcomes (1)

  • LUS findings at enrollment

    8 hours

Secondary Outcomes (1)

  • Repeat LUS findings

    30 days

Study Arms (4)

Mozambique, cases

Device: Lung ultrasound

Mozambique, controls

Device: Lung ultrasound

Pakistan, cases

Device: Lung ultrasound

Pakistan, controls

Device: Lung ultrasound

Interventions

Lung ultrasoundDEVICE

Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.

Mozambique, casesMozambique, controlsPakistan, casesPakistan, controls

Eligibility Criteria

Age2 Months - 23 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Cases will be children 2 through 23 months of age who present to a study hospital with history of cough or difficulty breathing and chest indrawing. Controls will be children 2 through 23 months of age who present with cough or difficulty breathing, but without chest indrawing, fast breathing or fever.

You may qualify if:

  • Male or female, 2 through 23 months of age
  • Cough \<14 days or difficulty breathing
  • Visible indrawing of the chest wall, with or without fast breathing
  • Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit
  • Male or female, 2 through 23 months of age
  • Cough \<14 days or difficulty breathing
  • Ability and willingness of child's caregiver to provide informed consent and to be available for follow-up for the planned duration of the study, including accepting a home visit if he/she fails to return to the study facility for a scheduled follow-up visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Centro de Investigação em Saúde de Manhiça (CISM)

Manhiça, Mozambique

Location

Aga Khan University

Karachi, Pakistan

Location

Related Publications (2)

  • Riaz A, Cambaco O, Ellington LE, Lenahan JL, Munguambe K, Mehmood U, Lamorte A, Qaisar S, Baloch B, Kanth N, Nisar MI, Volpicelli G, Bassat Q, Jehan F, Ginsburg AS. Feasibility, usability and acceptability of paediatric lung ultrasound among healthcare providers and caregivers for the diagnosis of childhood pneumonia in resource-constrained settings: a qualitative study. BMJ Open. 2021 Mar 11;11(3):e042547. doi: 10.1136/bmjopen-2020-042547.

    PMID: 33707268DERIVED

  • Lenahan JL, Volpicelli G, Lamorte A, Jehan F, Bassat Q, Ginsburg AS. Multicentre pilot study evaluation of lung ultrasound for the management of paediatric pneumonia in low-resource settings: a study protocol. BMJ Open Respir Res. 2018 Dec 19;5(1):e000340. doi: 10.1136/bmjresp-2018-000340. eCollection 2018.

    PMID: 30622716DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Respiratory and blood samples

MeSH Terms

Conditions

PneumoniaDisease

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsLung DiseasesRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 12, 2017

First Posted

June 14, 2017

Study Start

July 31, 2017

Primary Completion

January 8, 2019

Study Completion

January 8, 2019

Last Updated

April 8, 2019

Record last verified: 2019-04

Data Sharing

IPD Sharing
Will not share

There is no plan to make individual participant data (IPD) available to other researchers.

Locations

MO(1)PA(1)