Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201807164196402 Date of Approval: 23/07/2018
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Pulse oximetry and integrated management of childhood illness for diagnosis of childhood pneumonia in primary health care units of rural Ethiopia: study protocol for a cluster randomized controlled trial
Official scientific title Pulse oximetry and integrated management of childhood illness for diagnosis of childhood pneumonia in primary health care units of rural Ethiopia: study protocol for a cluster randomized controlled trial
Brief summary describing the background and objectives of the trial Background: The World Health Organization¿s integrated management of childhood illness algorithm is currently used in resource limited countries for managing childhood pneumonia. However, this algorithm has limitation in accurately classifying children with pneumonia and in identifying children who are in need of oxygen therapy. Therefore, this study aimed to see if the introduction of pulse oximetry would improve the performance of health workers for diagnosing severe childhood pneumonia and the cost effectiveness of this intervention at primary health care units. Primary objective The primary objective of this study is to compare whether the combined use of integrated management of childhood illness (IMCI) algorithm and pulse oximetry increases the proportion of severe pneumonia case detection, among children aged 2 month to 59 month, compared to integrated management of childhood illness algorithm only. Secondary objectives The secondary objectives of the study are: i. To determine whether combined use of IMCI algorithm and pulse oximetry increases the proportion of pneumonia cases referred to hospital. ii. To assess the treatment failure (up to 2, 5 and 14 days) after treatment with IMCI and pulse oximetry versus IMCI algorithm alone. iii. To estimate the incremental cost effectiveness of the combined use of IMCI algorithm and pulse oximetry with IMCI algorithm alone.
Type of trial RCT
Acronym (If the trial has an acronym then please provide) RCT
Disease(s) or condition(s) being studied Pneumonia ,Respiratory
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Diagnosis / Prognosis
Anticipated trial start date 17/08/2018
Actual trial start date 09/08/2018
Anticipated date of last follow up 26/11/2018
Actual Last follow-up date 26/11/2018
Anticipated target sample size (number of participants) 1440
Actual target sample size (number of participants) 1440
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomization using a randomization table created by a computer software program Central randomisation by phone/fax Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Combined use of the WHO Integrated management of childhood illness algorithm with pulse oximetry For 3-6 months Pulse oximetry will be used in intervention arm. Health workers in intervention arm will use pulse oximetry to measure oxygen saturation of each child. Measurement of oxygen saturation will be taken after health workers classify pneumonia based on the IMCI guideline. Oxygen saturation will be measured twice 5 minutes apart. Oxygen saturation shall be measured when the child is calm and the oxygen saturation shall be recorded when the pulse oximetry accurately reflected consistent, high amplitude plethysmographic waveforms associated with stable oxygen saturation for 1 minute. 720
Control Group Integrated management of childhood illness guideline 3-6 months The WHO IMCI guideline will be used to manage children with childhood pneumonia both in intervention and control arms. The guideline was developed based on expert opinion and research results and it goes through subsequent revisions. The guideline combines curative interventions for common child hood illnesses: Pneumonia, diarrhea, malaria, malnutrition, measles, anemia, meningitis, sepsis, and ear infection, and preventive interventions: immunization, nutrition counselling and breastfeeding support. The guidelines rely on detection of cases based on simple clinical signs. Based on the training courses health workers follow a series of steps including: assess for clinical signs, classify the child’s illness, identify treatment, counselling and follow up. The first draft training of this guideline was tested in six outpatient primary health care units of Ethiopia in 1997 . 720 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Patients presenting with symptoms suggestive of pneumonia will be included in the study. Patients with a long history of cough wherein differential diagnosis is tuberculosis, will be excluded. However, patients suspected of having tuberculosis will be referred to the nearest hospital. Patients with chronic cough of more than two weeks duration will not be included in this study. Infant: 0 Month-23 Month,Infant: 1 Month-23 Month,Preschool Child: 2 Year-5 Year 2 Month(s) 59 Month(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/04/2018 Medical Research Ethics South East Norway
Ethics Committee Address
Street address City Postal code Country
Gullhaugveien 1- 3 0484 Oslo Oslo 0318 Norway
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The primary study outcome will be severe pneumonia cases as assessed by IMCI algorithm and pulse oximetry. The primary Outcome will be measured at baseline
Secondary Outcome Severe pneumonia cases referred to hospital by health workers. At base line
Secondary Outcome Treatment failure on day 2 after enrollment. on day 2 after enrollment
Secondary Outcome Cumulative treatment failure up to 5 and 14 days after enrollment on day 5 and 4
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Dilla Gedeo zone Dilla Dilla 419 Ethiopia
FUNDING SOURCES
Name of source Street address City Postal code Country
Norwegian Programme for Capacity Development in Higher Education and Research for Development in Norway 0257 Oslo Oslo 0030 Norway
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Centre for international health Overlege Danielsens Hus, Arstadveien Bergen Bergen 5020 Norway University
COLLABORATORS
Name Street address City Postal code Country
University of Bergen 5007 Bergen, Norway Bergen 5007 Norway
Hawassa University Hawassa Hawssa Ethiopia
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Bernt Lindtjorn bernt.lindtjorn@cih.uib.no +4795056812 Overlege Danielsens Hus, Arstadveien Bergen
City Postal code Country Position/Affiliation
Bergen 5020 Norway University of Bergen
Role Name Email Phone Street address
Public Enquiries Solomon Hailemariam solomon0917242124@gmail.com +251917242124 Dilla
City Postal code Country Position/Affiliation
Dilla 0419 Ethiopia Dilla University
Role Name Email Phone Street address
Scientific Enquiries Kjell Arne kjell.johansson@uib.no +4797191828 Overlege Danielsens Hus, Arstadveien Bergen
City Postal code Country Position/Affiliation
Bergen 5020 Norway University of Bergen
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Undecided
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information