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Pulse Oximetry and Oxygen Services for the Care of Acutely Unwell Children with Pneumonia or COVID-19 Attending Frontline Health Facilities in Lagos, Nigeria (INSPIRING-Lagos)

Pulse Oximetry and Oxygen Services for the Care of Acutely Unwell Children with Pneumonia or COVID-19 Attending Frontline Health Facilities in Lagos, Nigeria (INSPIRING-Lagos)

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12621001071819
Acronym
INSPIRING-Lagos (Integrated Sustainable Childhood Pneumonia and Infectious disease Reduction in Nige
Enrollment
840
Registered
2021-08-13
Start date
2020-08-06
Completion date
2022-08-31
Last updated
2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

We will evaluate the introduction of stabilisation rooms equipped with pulse oximetry and oxygen systems to frontline health facilities in an urban area of Nigeria. We hypothesise that stabilisation rooms, implemented alongside clinical training and support, will improve the quality of care for children with pneumonia and reduce deaths. While our evaluation focus is on children under 5 years of age with pneumonia, the intervention will be available to benefit all children and adults receiving care from participating facilities. If we find that stabilisation rooms are effective it will inform government and World Health Organization recommendations and policies about pulse oximetry and oxygen for smaller health facilities.

Interventions

The project will establish “stabilisation rooms” within the outpatient areas of participating primary facilities, designed to allow for short-term oxygen delivery for children with hypoxaemia prior to transfer to hospital (or admission to the ward). These stabilisation rooms are intended to support both short-term COVID-19 and longer-term paediatric pneumonia care needs, and will consist of the following intervention components: 1. Pulse oximeters, equipped with both paediatric and adult re-usab

The project will establish “stabilisation rooms” within the outpatient areas of participating primary facilities, designed to allow for short-term oxygen delivery for children with hypoxaemia prior to transfer to hospital (or admission to the ward). These stabilisation rooms are intended to support both short-term COVID-19 and longer-term paediatric pneumonia care needs, and will consist of the following intervention components: 1. Pulse oximeters, equipped with both paediatric and adult re-usable probes; 2. Medical oxygen supply delivered through newly installed oxygen concentrators powered from mains supply, generators and/or solar power; 3. Clinical guidelines and job aids (alongside clinical training, described below). Secondary health facilities that admit children will also be supported with pulse oximeters and oxygen concentrators for use on the wards to support safe care of patients referred for inpatient care. Precise use of the stabilisation room will vary between facilities, but in general: all acutely unwell children will be screened for hypoxaemia; all children with severe hypoxaemia (SpO<90%) will be commenced on oxygen therapy; all hypoxaemia children will be admitted for a period of observation/treatment either at the same facility or via referral to a larger facility. Selection of devices was based on national and international technical guidance and experience with similar devices in Nigeria and elsewhere. To facilitate a sub-study comparing the usability and acceptability of two oximeters, facilities will be randomly allocated to receive either Lifebox (Acare Technology, New Taipei City, Taiwan) or Masimo RadG (Masimo, Irvine CA, USA) oximeters. We anticipate a 1-6 month delay in receiving both oxygen and oximetry equipment, given the global supply chain challenges during the COVID-19 pandemic; therefore, the evaluation design will need to be adaptive and flexible. The intervention will be delivered by Save the Children Nigeria, with technical support provided by private non-profit Oxygen for Life Initiative (OLI), working closely with local government. The stabilisation rooms will be implemented alongside broader capacity-building activities targeting primary care HCW practices (preventive and curative). This will include training on WHO’s IMCI guidelines, pulse oximetry and oxygen therapy, immunization, and nutrition. - Integrated Management of Childhood Illness (IMCI) In primary facilities, 6 days. For Community Health Extension Worker, Community Health Officers, nurses, - Pulse oximetry and Oxygen therapy In primary and secondary care facilities, 3 days. Community Health Extension Worker, Community Health Officers, nurses, midwives, doctors, +/- technicians - Immunization “Reaching Every District” In primary care facilities, 2-3 days. Vaccinators, immunisation focal persons, facility officer in charge - Nutrition – Infant and Young Child Feeding (IYCF), Community Management of Acute Malnutrition (CMAM) In training centre and primary care facilities, 3 days. Repeated after 1 year for new staff. Community Health Extension Worker, Community Health Officers, nurses, nutrition focal person All training activities will be coordinated by Save the Children Nigeria using the ADDIE model (A = Analysis, D = Design, D = Develop Training Materials, I = Implement/Delivery, and E = Evaluation). Save the Children Nigeria will conduct a Training Needs Assessments using their “Task Analysis” tools, assessing a health care worker’s actual skills and knowledge compared to the skills and knowledge they are meant to have based on their job descriptions. The training will be adapted from existing standard training packages to the local context with the assistance of local facilitators selected from the State Ministry of Health (SMOH) and partners (e.g. WHO, UNICEF, OLI). Training is based on existing modules (e.g. IMCI) where available and will involve a mix of didactic, observational, and participatory teaching strategies. Local facilitators who lead the training will also act as coaches, mentors and supervisors after the training has been completed and the participants have been deployed. They will visit each facility every 4-6 weeks and maintain interim contact using mobile phone-based group messaging. The Ikorodu LGA health team will also contribute to supervision through existing immunization supportive supervision arrangements. External evaluation team members will attend some training activities as observers and review administrative records to evaluate intervention fidelity. Clinical data collection will include items to measure adherence to guidelines. The program will be delivered and evaluated over 2 years (12 month intervention period), and may continue indefinitely following satisfactory program evaluation.

Sponsors

University College London
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
0 to 59 Months
Healthy volunteers
No

Inclusion criteria

The intervention and impact evaluation will focus on children aged 0-59 months attending the outpatient areas of participating facilities for an acute illness and who are diagnosed with clinical pneumonia defined according to the 2014 WHO IMCI guidelines.

Exclusion criteria

No additional exclusion criteria.

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 12, 2026