Investigating pneumonia in children under 5 years of age in Indonesia

ISRCTN ISRCTN79204992
DOI https://doi.org/10.1186/ISRCTN79204992
Secondary identifying numbers RIDA261119
Submission date
09/12/2019
Registration date
11/12/2019
Last edited
09/04/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Even though identification and treatment has improved, pneumonia (inflammation and swelling of the lungs often caused by an infection) is the leading cause of death in children worldwide, with approximately 1 million deaths each year. Indonesia has a high rate of pneumonia in children, with 1 in 5 children aged under 5 years suffering from pneumonia each year. This study aims to observe children aged under 5 years in Indonesia who have pneumonia to investigate the type of infection that has caused it, the antibiotics that can kill the bacteria involved and the risk factors that make a child more likely to have pneumonia. The results are expected to help with planning treatment and vaccine use.

Who can participate?
Children aged under 5 years who have a cough or difficulty breathing and have fast breathing, as long as the first sign of illness was less than 14 days previously.

What does the study involve?
Children suspected of having pneumonia will be identified at community health centres in different parts of Indonesia. They will have blood samples taken as part of the study and will have their throat and nose swabbed so that bacteria and viruses can be identified. The parents will be asked questions to identify potential risk factors using a questionnaire.

What are the possible benefits and risks of participating?
This is an observational study, which means that the participants receive treatment as usual. There is no risk or benefit of participating.

Where is the study run from?
Diponegoro University (Indonesia)

When is the study starting and how long is it expected to run for?
October 2019 to October 2023

Who is funding the study?
Diponegoro University (Indonesia)

Who is the main contact?
Dr Vincentia Rizke Ciptaningtyas, ciptaningtyas_vr@fk.undip.ac.id

Study website

Contact information

Mrs Vincentia Rizke Ciptaningtyas
Scientific

Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia

ORCiD logoORCID ID 0000-0001-5910-4937
Phone +62 81325755503
Email ciptaningtyas_vr@fk.undip.ac.id
Mrs Vincentia Rizke Ciptaningtyas
Public

Diponegoro University Faculty of Medicine
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia

ORCiD logoORCID ID 0000-0001-5910-4937
Phone +62 81325755503
Email Rizke.Ciptaningtyas@radboudumc.nl

Study information

Study designMulticentre observational (longitudinal case-control) study
Primary study designObservational
Secondary study designCase-control study
Study setting(s)Community
Study typeDiagnostic
Participant information sheet Not available in web format, please use the contact details below to request a participant information sheet.
Scientific titleInvestigation of the modifiable risk factors and etiology of lower respiratory tract infections of children under five years of age in Indonesia
Study acronymRIDA
Study objectivesA better understanding of the etiology, risk factors and antimicrobial resistance patterns among children with lower respiratory tract infection (LRTI) will improve the healthcare for these patients in Indonesia. Hence, reducing childhood morbidity and mortality caused by LRTI and thereby supporting the third ‘sustainable development goal’.
Ethics approval(s)Approved 04/12/2019, Diponegoro University Faculty of Medicine Health Research Ethics Committee (Kantor Dekanat Lama FK Undip lt.1, Jl. Dr. Soetomo 18, Semarang, Indonesia; +62 024-769280010 ext 7820; komisietik@gmail.com), ref: 506/EC/KEPK/FK UNDIP/XII/2019
Health condition(s) or problem(s) studiedLower respiratory tract infection among children aged under 5 years
InterventionThis study is designed as a case control study, whereby cases will be matched with controls (matched by age, sex, time of admission ). Cases will be identified at community health center (Puskesmas) and controls will be enrolled by post for integrated services (Posyandu) where the community health center is located.

All participants will receive a one-time intervention immediately after they have given their consent. The researchers will take a medical history from the parent or carer and physically examine the children, including pulse oximetry. Nasopharyngeal swab, oropharyngeal swab and peripheral vein (blood and serum) will be taken. Information about risk factors will be obtained through a questionnaire designed specifically for this study. Questions in our questionnaire relate to caregiver socio-demographic information (specifically level of education and salary), participant socio-demographic information (specifically antenatal care, breastfeeding and previous illness), immunization status, home-related factors and tobacco exposure.
Intervention typeOther
Primary outcome measureEtiology (with a primary focus on bacteria and viruses) of LRTI identified using conventional (bacterial culture) and molecular methods.
Secondary outcome measures1. Risk factors assessed using parents' and guardians' responses to a questionnaire
2. Antimicrobial sensitivity patterns of isolated bacterial pathogens
3. Virus identification using multiplex PCR
4. Pneumococcal serotypes causing pneumonia identified using multiplex PCR and the Quellung reaction
Overall study start date01/10/2019
Completion date01/10/2022

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit2 Months
Upper age limit59 Months
SexBoth
Target number of participants450
Key inclusion criteria1. Cough or difficulty in breathing
2. Fast breathing:
2.1. In children aged 2 to 11 months, with breathing rate ≥50 breaths per min
2.2. In children aged 12 to 59 months, with breathing rate ≥40 breaths per min
3. First symptom appearing within the last 14 days
4. Aged under 5 years
Key exclusion criteria1. Hospitalized for more than 24 h at enrolment
2. Cancer or history of cancer
3. History of long-term (more than 2 months) exposure to steroid drugs
Date of first enrolment01/06/2020
Date of final enrolment01/10/2022

Locations

Countries of recruitment

  • Indonesia

Study participating centre

Universitas Diponegoro
Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia

Sponsor information

Universitas Diponegoro [Diponegoro University]
University/education

Jl. Prof. Soedarto SH
Kelurahan Tembalang
Kecamatan Tembalang
Semarang
50275
Indonesia

Phone +62 24 76928010
Email dean@fk.undip.ac.id
Website https://www.undip.ac.id/language/id/

Funders

Funder type

University/education

Universitas Diponegoro
Government organisation / Local government
Alternative name(s)
undip, Universitas Diponegoro (UNDIP, Universitas Diponegoro (UNDIP) (Semarang, Indonesia), Universitas Diponegoro (UNDIP) Semarang, UNIVERSITAS DIPONEGORO The Excellent Research University, Diponegoro University, UNDIP
Location
Indonesia

Results and Publications

Intention to publish date01/10/2023
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planThe findings from this research study will be published in an appropriate scientific journal (and made available open access) and/or presented at an appropriate meeting.
IPD sharing planThe data sharing plans for the current study are unknown and will be made available at a later date.

Editorial Notes

09/04/2020: The recruitment start date was changed from 01/03/2020 to 01/06/2020.
11/12/2019: Trial's existence confirmed by Diponegoro University Faculty of Medicine Health Research Ethics Committee.