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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202206525204526 Date of Registration: 15/06/2022
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title AIRE RESEARCH PROTOCOL: OPERATIONAL EVALUATION OF THE ROUTINE PULSE OXYMETER IMPLEMENTATION INTO THE INTEGRATED MANAGEMENT OF CHILDHOOD ILLNESS (PAPER AND ELECTRONIC) AT PRIMARY HEALTH CARE LEVEL IN WEST AFRICA
Official scientific title AIRE RESEARCH PROTOCOL: «EVALUATING THE OPERATIONAL IMPLEMENTATION OF DECENTRALIZED PULSE OXYMETER IN CHILDREN»
Brief summary describing the background and objectives of the trial The AIRE project is aimed to contribute to the reduction of neonatal and infant mortality caused by hypoxemia. We will evaluate the implementation of routine Pulse Oximeters (PO) in the Integrated Management of Childhood Illness (IMCI) approach among consultations in children under 5 years at primary health care centers (PHC). The introduction of POs aims to strengthen the diagnosis of hypoxemia (defined as a SpO2 measurement< 90%) among all severe (respiratory and non-respiratory) cases to allow for a prompt and effective referral to a hospital with an appropriate case management (oxygen, antibiotic therapy and other required treatments) in the West African health context. Between July 2019 and December 2022, the AIRE project will be implemented by The Alliance for International Medical Action (ALIMA), in partnership with Solidarité Thérapeutique et Initiatives pour la Santé (Solthis), Terre des hommes (Tdh) and the Institut National de la Santé et de la Recherche Médicale (Inserm). In West Africa, there remains limited information about the epidemiology, identification, pathways of care, patterns of care, costs and outcomes of children with severe diseases at the PHC level. The primary objective of the AIRE operational research protocol is to assess the process of routine PO use (with hospital referral if hypoxemia is diagnosed by Sp02<90% as recommended by WHO) during the IMCI (paper-based or electronic-based) consultation of children under 5 years at the primary health centers (PHC) in West Africa. This study will have three components: a) the context evaluation (infrastructures, staff, P0 use, IMCI outpatient’s characteristics), b) the process evaluation (feasibility, acceptability, fidelity, implementation challenges, context-mechanism-outcome configurations), and c) the outcomes evaluation (pathways of care, patterns of care, Day-14 health outcomes for severe cases only and costs of care).
Type of trial CCT
Acronym (If the trial has an acronym then please provide) AIRE
Disease(s) or condition(s) being studied Infections and Infestations,Paediatrics
Sub-Disease(s) or condition(s) being studied Respiratory and non respiratory
Purpose of the trial Treatment: Devices
Anticipated trial start date 03/01/2021
Actual trial start date 14/06/2021
Anticipated date of last follow up 31/07/2022
Actual Last follow-up date
Anticipated target sample size (number of participants) 40000
Actual target sample size (number of participants)
Recruitment status 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
Crossover: all participants receive all interventions in different sequence during study Non-randomised Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Use of pulse oxymeter each IMCI consultation each IMCI consultation Use of Pulse Oxymeter during the IMCI consultation at Primary Health Centre level 40000
Experimental Group Follow up of all severe cases included in AIRE research For each IMCI consultation For each IMCI consultation Follow up at day 14 for each severe cases included in AIRE research 6000
Control Group Use of Pulse Oxymeter integrated into IMCI consultation Each IMCI consultation Each IMCI consultation For each child under five years of age who comes to the primary health center during the data collection period, an IMCI consultation will be conducted and will end with a clinical classification. Then, for those eligible for SpO2 measurement, oxygen saturation will be measured and the IMCI integrating Pulse Oxymeter classification will be determined. 40000 Uncontrolled
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
The PO will be used among the following eligible children according to the IMCI classification and depending on age and signs: • 0-59 days: All sick children. • 2-59 months, with cough and breathing difficulties: All sick children (green, yellow or red) • 2-59 months, without cough and breathing difficulties: those classified as moderate (yellow) or severe (red). All neonates (0 to 59 days) and children (2 to 59 months) attending IMCI consultation in research sites of the AIRE project will be screened for PO use eligibility criteria detailed above by the health care professional working at the PHCs. Those eligible for whom at least one caregiver has given consent will be enrolled over the recruitment period None Infant: 1 Month(s)-12 Month(s),Infant: 13 Month(s)-24 Month(s),New born: 0 Day-1 Month,Preschool Child: 2 Year-5 Year 0 Day(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 05/11/2020 Comite National d ethique pour la recherche en sante
Ethics Committee Address
Street address City Postal code Country
NA Conakry NA Guinea
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 11/05/2021 COMITE NATIONAL D ETHIQUE POUR LA SANTE ET LES SCIENCES DE LA VIE
Ethics Committee Address
Street address City Postal code Country
NA Bamako 5241 Mali
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 02/12/2020 Comite National d ethique pour la recherche en sante
Ethics Committee Address
Street address City Postal code Country
NA NIAMEY NA Niger
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 04/11/2020 COMITE D ETHIQUE POUR LA RECHERCHE EN SANTE
Ethics Committee Address
Street address City Postal code Country
NA OUAGADOUGOU NA Burkina Faso
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 11/05/2021 COMITE D EVALUATION ETHIQUE DE L INSERM
Ethics Committee Address
Street address City Postal code Country
101 RUE DE TOLBIAC Paris 75654 France
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 18/03/2021 Research Ethics Review Committee WHO ERC
Ethics Committee Address
Street address City Postal code Country
20 Avenue Appia GENEVE CH 1211 Switzerland
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome The study primary endpoint is the added-value of the use of pulse oxymeter in the identification of severe case, respiratory and non respiratory, at PHC level, among all children attended to IMCI consultation in the 4 countries At the end of data collection period and data cleaning
Secondary Outcome Pathways of care after hospital referral to describe the cascade of care: hospitalizations achieved among severe cases at PHC and delay, drop-out after referral and causes of non-referral, return to care End of data collection period and data cleaning
Secondary Outcome Patterns of care at hospital: PO use and SpO2 measurement at entry, coverage of oxygen therapy, injectable antibiotics, ACTS, and other specific treatments… (in %, delays, volume, and duration), hospital length, and outcome at hospital discharge End of data collection period and data cleaning
Secondary Outcome Direct and indirect of both medical and non-medical costs (costs of consultations, medicines, medical equipment, examination and care, staff costs, PO deployment, transport to health centers and hospitals, childcare, accommodation), including loss of income for people accompanying children End of data collection period and data cleaning
Secondary Outcome Short-term health outcomes at 14 days in terms of vital status and care (died, alive and cured, alive still in care, alive but return to care, lost-to-follow-up), whether they were hospitalized or not and dates of death if any End of data collection period and data cleaning
Primary Outcome Description of how the AIRE project works, for who, in which specific contexts and why, using a realist evaluation End of data collection period and data cleaning
Primary Outcome Level of acceptability of the innovation (POs) introduced by the project among health workers and children’s caregivers End of data collection period and data cleaning
Secondary Outcome Description of the implementation fidelity, meaning to which extent the final implementation is in line with the planned AIRE project activities (explore if the activities planned by the project have actually been implemented, and as often and as long as initially planned End of data collection period and data cleaning
Secondary Outcome State how the implementation of the AIRE project is organized, what are its challenges, what are the factors that influence it (including e-IMCI vs paper-IMCI) End of data collection period and data cleaning
Primary Outcome Description of all AIRE sites introducing PO over the study period: health infrastructures, health care staff, frequency of PO use, and IMCI outpatient characteristics End of data collection period and data cleaning
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Santou PHC Telimele Telimele Guinea
Wacoro PHC Dioila Dioila Mali
Ouahabou PHC Boromo Boromo Burkina Faso
Aeroport2 PHC Niamey4 Niamey Niger
Sarekaly PHC Telimele Telimele Guinea
Sinta PHC Telimele Telimele Guinea
Telimele PHC Telimele Telimele Guinea
Baoufoulala PHC Dioila Dioila Mali
Dougabougou PHC Markala Markala Mali
Sibila PHC Markala Markala Mali
Oury PHC Boromo Boromo Burkina Faso
Bissanderou PHC Dedougou Dedougou Burkina Faso
Gamkalle PHC Niamey4 Niamey Niger
Garankedey PHC Dosso Dosso Niger
Kigoudou Koara PHC Dosso Dosso Niger
FUNDING SOURCES
Name of source Street address City Postal code Country
UNITAID Global Health Campus, Chemin du Pommier 40, 5th floor, 1218 Grand-Saconnex Geneva 1218 Switzerland
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor ALIMA NGO Rue NG 96 Route de l aeroport Dakar 15530 Senegal Consortium Lead
COLLABORATORS
Name Street address City Postal code Country
Terre des Homme Lausanne Avenue de Montchoisi 15 Lausanne 1006 Switzerland
Solthis 34 Avenue Jean Jaures Paris 75019 France
Inserm 37 Allees Jules Guesde Toulouse 31073 France
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Valeriane LEROY valeriane.leroy@inserm.fr +33672432636 37 Allees Julles Guesde
City Postal code Country Position/Affiliation
Toulouse 31073 France Directrice de Recherche Inserm
Role Name Email Phone Street address
Public Enquiries Marine VIGNON marine.vignon@alima.ngo 00221778554159 Rue NG 96 Route de l aeroport
City Postal code Country Position/Affiliation
Dakar 15530 Senegal Project Manager ALIMA
Role Name Email Phone Street address
Scientific Enquiries Gildas Boris HEDIBLE gildas.hedible@inserm.fr +33610178078 37 Allees Jules Guesde
City Postal code Country Position/Affiliation
Toulouse 31073 France Research project manager Inserm
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes The AIRE data sharing agreement describes the terms and conditions associated with the storage, access, protection, and use of data collected as part of the AIRE project. Informed Consent Form,Statistical Analysis Plan,Study Protocol At the end of 2022 according to AIRE publication plan The Processed Data will be converted into a digital table format and can be distributed by the Data Manager via secured web transfer (FTPS). The following Parties will have access to the Processed Data: 􀶷 Inserm, Université Toulouse (CERPOP, U1295), Toulouse, France 􀶷 ALIMA 􀶷 Terre des hommes foundation 􀂱 Lausanne 􀶷 Solthis, 􀶷 IRD CEPED, Paris, France 􀶷 PACCI, Abidjan, Côte d'Ivoire Within the calendar after the release of the AIRE publication plan, exclusive access to the data will be granted to parties listed above. Other parties may have access to data and publish information if they receive approval from AIRE consortium. After the AIRE publication plan is released, a Party can use the Data in any publication if prior written consent has been obtained from the AIRE consortium. Access to Processed Data will be made available to any third Party after the publication of the AIRE publication plan, upon a motivated request (concept sheet) and after the AIRE consortium approval of the AIRE consortium and PI of Burkina Faso, Guinea, Mali and Niger if still active, and the written consent of the AIRE research coordinator (Inserm U1295 Toulouse, France). All AIRE project data sharing group members will observe rules for protecting confidentiality of participants and reporting only reliable results created by the AIRE project data sharing group.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 14/06/2022
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 14/06/2022
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information