Understanding current childhood pneumonia management practices in a few selected low- and middle-income countries

Plain English Summary

Background and study aims
Pneumonia is the leading cause of morbidity and mortality in children 1-59 months of age. An estimated 138 million pneumonia episodes occurred in under-five children in 2015. Of these, 16% had chest indrawing pneumonia. Every year, pneumonia causes over 800,000 deaths in under-five children, and the burden is disproportionately borne by children living in sub-Saharan Africa and South Asia. The WHO revised the childhood pneumonia classification in 2013. The revised classification includes only two categories of pneumonia; “pneumonia” with fast breathing and/or lower chest indrawing, which requires outpatient therapy with oral amoxicillin, and “severe pneumonia”, pneumonia with any general danger sign, which requires referral to a hospital for injectable antibiotic treatment. Subsequently, in 2014, the WHO revised its pocketbook and IMCI chart booklet to incorporate the treatment of chest indrawing pneumonia with oral amoxicillin. Since 2014, several countries have adopted the new recommendation to treat children with lower chest indrawing pneumonia with oral amoxicillin on an outpatient basis.
In 2018, a retrospective analysis of data from hospitalised children with pneumonia in Kenya showed high mortality among children with mild to moderate palmar pallor, weight-for-age z score (WAZ) less than -3 standard deviation and lower chest indrawing. The authors recommended that these children be treated in a hospital instead of on an outpatient basis as per the current WHO recommendation. A 2-day exploratory meeting of pneumonia research experts was held in WHO, Geneva, in September 2018 to evaluate the implications of this new evidence and other data. The expert panel suggested short-term prospective observational/cohort studies to collect outcome data for children 2–59 months old with lower chest indrawing in real-life settings where the current WHO pneumonia guidelines are being implemented in an outpatient setting. Although 45 countries have revised their national policy to manage children with chest-indrawing pneumonia on an outpatient basis, there is little empirical evidence and experience about its implementation in a programme setting. Thus, it is essential to study this. A prospective observational study will help us gather information from health facilities in some selected countries in various regions concerning the management of children with chest indrawing pneumonia and its outcomes when managed on an outpatient basis.

Who can participate?
Children 2-59 months old with chest-indrawing pneumonia presenting at the participating primary health care facility

What does the study involve?
A prospective observational cohort study will be conducted. The primary objective is to evaluate the survival status (outcome) by day 15 after presentation at a primary health care facility in a programme setting. The secondary objective is to examine survival status and management (including oral treatment, which one, for how many days, or hospitalisation, with injectable antibiotics, how many days, and treatment adherence).

The study will be conducted at the primary care health facility level, where trained healthcare workers are available. The healthcare worker will assess a child with a cough and/or difficulty breathing presenting at the primary care facility. Based on the assessment, the healthcare worker will classify the child into no pneumonia, fast-breathing pneumonia, chest-indrawing pneumonia, severe pneumonia, and manage (treat or refer) according to the national guidelines/policy. The healthcare worker will enter information such as the patient’s name, age, address, parents’ phone number, clinical assessment, and treatment given into the facility register. Further, the healthcare worker will also take the informed written consent from the parents of all children for the day 15 follow-up.

The research staff will collect the information of all the recruited children from the facility who register daily for follow-up visits. On day 15, the research team member will visit the child’s home or hospital to collect information about the vital status of the child and treatment. A total of 310 children 2-59 months of age with chest-indrawing pneumonia will be followed up at each site. Depending on the site, all study data will be collected on paper or an electronic device. Protecting the confidentiality of the data collected in the study will be a high priority. Data will be primarily accessible only to the 'Research Team'. The data/records will be kept for 5 years from the initial assessment date to complete all analyses, and then they will be destroyed.

Data will be analysed using STATA software. Frequencies and percentages will be calculated for categorical variables such as sex, treatment received and vital outcome. At the same time, mean (standard deviation) and median (interquartile range) will be calculated for continuous variables such as age, days of treatment, etc.
However, sites will be finalised in consultation with the WHO regional offices. The study will be conducted in three phases [preparatory phase (duration three months), data collection phase (duration 12 months), and data analysis, report writing and dissemination of results (duration three months)].

What are the possible benefits and risks of participating?
As this study does not provide any intervention, there will be no direct benefit or risk.

Where is the study run from?
The study will be conducted in 6-8 selected countries (a few in Africa, such as Ethiopia, Kenya, Nigeria and Tanzania, and a few in Asia, such as Bangladesh, India, Nepal and Pakistan) where their national policy recommends treatment of 2-59 months old children with chest-indrawing pneumonia on an outpatient basis.

When is the study starting and how long is it expected to run for?
April 2021 to June 2025

Who is funding the study?
Bill and Melinda Gates Foundation (USA)

Who is the main contact?
Yasir Bin Nisar, nisary@who.int (Switzerland)

Contact information

Dr Yasir Bin Nisar
Public, Scientific, Principal Investigator

World Health Organization
Avenue Appia 20
Geneva
1202
Switzerland

ORCID ID	0000-0002-9720-5699
Phone	+41227915595
Email	nisary@who.int

Study information

Eligibility

Locations

Countries of recruitment

• Ethiopia
• India
• Nigeria
• Pakistan
• Uganda
• Zambia

Study participating centres

Sponsor information

World Health Organization
Charity

Ajantha Kumari Ranajeewa
Avenue Appia 20
Geneva
1202
Switzerland

Phone	+41 22 791 4303
Email	ranajeewaa@who.int
Website	https://www.who.int/
"ROR"	https://ror.org/01f80g185

Funders

Funder type

Charity

Results and Publications

Study outputs

Editorial Notes

31/03/2025: Publication reference added.
21/06/2024: Publication reference added.
14/11/2023: Study's existence confirmed by the World Health Organization Research Ethics Review Committee (WHO ERC).