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Pneumonia Childhood clinical trials

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NCT ID: NCT03446534 Recruiting - Clinical trials for Lower Respiratory Tract Infection

The Norwegian Antibiotics for Pneumonia in Children Study

NAPiC
Start date: March 7, 2018
Phase: Phase 4
Study type: Interventional

This study evaluates the effect of amoxicillin in the treatment of lower airway infections in preschool children. Half of the patients will receive amoxicillin, while the other half will receive placebo.

NCT ID: NCT03067558 Terminated - Pneumonia Childhood Clinical Trials

Acute Respiratory Infection Diagnostic Aids (ARIDA) Controlled Accuracy Evaluation Protocol

Start date: April 5, 2017
Phase: N/A
Study type: Observational

Pneumonia is the leading infectious cause of death among children under 5 years of age globally. Many pneumonia deaths result from late care seeking and inappropriate treatment due to misdiagnosis of symptoms. The United Nations Children's Fund's (UNICEF's) Acute Respiratory Infection Diagnostic Aids (ARIDA) project aims to introduce automated respiratory rate (RR) counting aids for use by frontline health workers in resource limited community settings and health facilities. These RR counting aids aim to offer improved accuracy, effectiveness and acceptability compared to current practices for counting and classifying RR to detect fast breathing pneumonia. The general aim of the controlled accuracy study is to understand whether the ARIDA test device accurately measures RR in children under 5 years of age with cough and/or difficult breathing. It is a cross-sectional, prospective study in a controlled setting comprising three types of device evaluations: 1. The accuracy of the ARIDA test device in measuring RR in young infants 0 to <2months, children 2 to <12 months and 12 to 59 months when compared to a video panel reference standard will be established through the first evaluation. 2. The consistency of the ARIDA test device will be established by determining the level of agreement between the measures of RR for two ARIDA test devices when used on the same child at the same time in those aged 2 to <12 months and 12 to 59 months through the second evaluation. 3. A third evaluation on a different group of normal-breathing children aged 2 to 59 months will assess RR fluctuation over time due to ARIDA test device attachment. Evaluations 1 and 2 for accuracy and consistency will also be undertaken with expert clinicians (EC) conducting a manual RR count to further the evidence base around the performance of current standard practice in a controlled setting. The study is a cross-sectional, prospective study and will be conducted in paediatric in and outpatient departments Saint Paul's Hospital and Millennium Medical Collage in Addis Ababa, Ethiopia.

NCT ID: NCT02669654 Recruiting - Pneumonia Childhood Clinical Trials

Effectiveness Trial of Day-care vs. Usual Care of Severe Pneumonia & Malnutrition in Children

Day-care
Start date: November 1, 2015
Phase: Phase 4
Study type: Interventional

Background: At present pneumonia and malnutrition have become the leading causes of mortality among <5-year-old children in developing countries. World Health Organization standard management of severe pneumonia and severe malnutrition requires hospitalization for supportive care. As many developing countries including Bangladesh do not have enough pediatric hospital beds to accommodate the demand for admission of all children with severe pneumonia and malnutrition, Investigators developed alternative treatment option such as "Day Care Approach", for those children who cannot be hospitalized, but are too sick to be managed in the community. After successful Day Care Approach of management of efficacy trials with severe childhood pneumonia and severe malnutrition, the next step is to conduct an effectiveness trial under "real life" condition, i.e. within the Health Systems of Bangladesh. Burden: Pneumonia is the leading cause of mortality in developing countries, being responsible for 1,368,000 (18%) of annual 7.6 million deaths, 95% occurring in developing countries. Similarly, malnutrition is a major health problem with an estimated 1.7 & 3.6 million children dying annually because of Severe Acute Malnutrition & Moderate Acute Malnutrition, respectively. Objectives: To assess & implement the Day Care Approach of management of severe childhood pneumonia with or without Moderate Acute Malnutrition and/or severe underweight into existing Health Systems of Bangladesh as a safe & cost effective alternative to Existing Treatment. Methods: A cluster randomized controlled trial will be conducted in Bangladesh by involving 16 clusters (Wards) in Dhaka & 16 clusters (Unions) in rural areas that will be randomly assigned to intervention & control arm. Children with severe pneumonia will be enrolled in (i) Tikatuli, (ii) Circular Road, (iii) Dhamrai Upazilla of Dhaka, (iv) Karimganj Upazillas to one of two management schemes: (i) Existing Treatment in control clusters or (ii) Day care Approach in intervention clusters by involving Comprehensive Reproductive Health Centres in urban and Health and Family Welfare Centres in rural areas. Outcome variables: - Primary: clinical treatment failure by day 6 - Secondary: (i) Treatment failure between day 7-14 in children who are well on day 6 (ii) Cost effectiveness (iii) Referrals to hospitals (iv) Deaths