Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Impact of Pulse Oximetry on Hospital Referral Acceptance in Children Under 5 With Severe Pneumonia

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: NCT03588377
Recruitment Status : Completed
First Posted : July 17, 2018
Last Update Posted : March 31, 2022
Sponsor:
Collaborator:
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
Dr Fatime Mir, Aga Khan University

Brief Summary:
The study assesses and compares the effect of 'pulse oximetry' (PO) used by Lady Health Workers (LHWs) at household level on increasing hospital referral acceptance rates in intervention clusters (district Jamshoro) for 0-59 months old children with severe pneumonia with the effect of LHWs using clinical signs alone in non-intervention clusters of the same district.

Condition or disease Intervention/treatment Phase
Severe Pneumonia Hypoxemia Device: Pulse Oximetry Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Diagnostic
Official Title: Impact of Pulse Oximetry on Hospital Referral Acceptance in Children Under 5 With Severe Pneumonia in District Jamshoro - A Cluster Randomized Trial - (GAPPD Scale up Project)
Actual Study Start Date : August 1, 2019
Actual Primary Completion Date : December 31, 2020
Actual Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Active Comparator: Intervention Cluster
Signs and symptoms of severe pneumonia Pulse Oximetry
Device: Pulse Oximetry

Intervention clusters:

On LHW's regular visits to households of their catchment area, they will daily screen for severe pneumonia and check oxygen level in blood using a pulse oximeter in all under <5 children with symptoms of cough or difficulty breathing

Case definition:

  1. Birth - 6 days: Fast breathing +/- Low oxygen in blood <92% (Hypoxemia)
  2. 7 days - 59 months: Fast breathing and/or Chest In-drawing + Any one danger sign: (Low oxygen in blood <92% (Hypoxemia), Refusing to eat, Vomiting continuously, Convulsions, Lethargy/ Unconsciousness, Stridor.

No Intervention: Non-Intervention Cluster
Signs and symptoms of severe pneumonia



Primary Outcome Measures :
  1. Hospital Referral Acceptance [ Time Frame: Day 3 to 7 ]
    Number of children accepting hospital referral out of total severe pneumonia identified

  2. Predictors of hospital referral acceptance [ Time Frame: Day 0-3 ]
    number of children having the predictors (severe signs and symptoms, low distance from referral facility and high WAMI score)


Secondary Outcome Measures :
  1. Comparison of clinical outcomes of children 0-59 months who accepted referral to those who refused admission and were treated at home [ Time Frame: Day 3 to Day 7 ]
    Treatment failure (no improvement in signs and symptoms of severe pneumonia at day 3 of identification), Deaths in above, Hypoxemia.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Children of 0-59 months age
  2. Signs of severe pneumonia (clinical signs only in control clusters, clinical signs and/or hypoxemia in intervention clusters)
  3. Written informed consent by legal guardian

Exclusion Criteria:

1. Residents of out of catchment areas


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03588377


Locations
Layout table for location information
Pakistan
Jāmshoro Office - AKU
Jāmshoro, Sindh, Pakistan, 76000
Sponsors and Collaborators
Aga Khan University
Bill and Melinda Gates Foundation
Investigators
Layout table for investigator information
Principal Investigator: Fatima Mir, FCPS Aga Khan University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Dr Fatime Mir, Associate Professor, Aga Khan University
ClinicalTrials.gov Identifier: NCT03588377    
Other Study ID Numbers: 4722-Ped-ERC-17
First Posted: July 17, 2018    Key Record Dates
Last Update Posted: March 31, 2022
Last Verified: March 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia
Hypoxia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases
Signs and Symptoms, Respiratory