Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Pediatric Pneumonia Lung Ultrasound (PLUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03187067
Recruitment Status : Completed
First Posted : June 14, 2017
Last Update Posted : April 8, 2019
Sponsor:
Collaborators:
Bill and Melinda Gates Foundation
Barcelona Institute for Global Health
Aga Khan University
Information provided by (Responsible Party):
Save the Children

Tracking Information
First Submitted Date June 12, 2017
First Posted Date June 14, 2017
Last Update Posted Date April 8, 2019
Actual Study Start Date July 31, 2017
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 12, 2017)
LUS findings at enrollment [ Time Frame: 8 hours ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 12, 2017)
Repeat LUS findings [ Time Frame: 30 days ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pediatric Pneumonia Lung Ultrasound
Official Title Evaluation of Impact of Lung Ultrasound (LUS) on Management of Pneumonia in Low-resource Settings
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
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Respiratory and blood samples
Sampling Method Non-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.
Condition
  • Pneumonia
  • Acute Respiratory Infection
Intervention Device: Lung ultrasound
Lung ultrasound will be performed on all children to investigate imaging patterns characteristic of pneumonia.
Study Groups/Cohorts
  • Mozambique, cases
    Intervention: Device: Lung ultrasound
  • Mozambique, controls
    Intervention: Device: Lung ultrasound
  • Pakistan, cases
    Intervention: Device: Lung ultrasound
  • Pakistan, controls
    Intervention: Device: Lung ultrasound
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 5, 2019)
270
Original Estimated Enrollment
 (submitted: June 12, 2017)
240
Actual Study Completion Date January 8, 2019
Actual Primary Completion Date January 8, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Months to 23 Months   (Child)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Mozambique,   Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number NCT03187067
Other Study ID Numbers PLUS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
IPD Sharing Statement
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available to other researchers.
Responsible Party Save the Children
Study Sponsor Save the Children
Collaborators
  • Bill and Melinda Gates Foundation
  • Barcelona Institute for Global Health
  • Aga Khan University
Investigators Not Provided
PRS Account Save the Children
Verification Date April 2019