PLUS: Pediatric Pneumonia Lung Ultrasound

Sponsor

Save the Children (Other)

Overall Status

Completed

CT.gov ID

NCT03187067

Collaborator

Bill and Melinda Gates Foundation (Other), Barcelona Institute for Global Health (Other), Aga Khan University (Other)

270

Enrollment

Locations

17.3

Actual Duration (Months)

135

Patients Per Site

7.8

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pneumonia Acute Respiratory Infection	Device: Lung ultrasound

Study Design

Study Type:

Observational

Actual Enrollment :

270 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings

Actual Study Start Date :

Jul 31, 2017

Actual Primary Completion Date :

Jan 8, 2019

Actual Study Completion Date :

Jan 8, 2019

Arms and Interventions

Arm	Intervention/Treatment
Mozambique, cases	Device: Lung ultrasound Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Mozambique, controls	Device: Lung ultrasound Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Pakistan, cases	Device: Lung ultrasound Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Pakistan, controls	Device: Lung ultrasound Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.

Outcome Measures

Primary Outcome Measures

LUS findings at enrollment [8 hours]

Secondary Outcome Measures

Repeat LUS findings [30 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Months to 23 Months

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria (chest indrawing cases):

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

Inclusion Criteria (non-chest indrawing controls):

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