Hypoxia Clinical Trial
Official title:
Evaluating Novel Pediatric Pulse Oximeters for Outpatient Child Pneumonia Care in Sub-Saharan Africa
The primary objective of this clinical trial is to evaluate the performance of three pulse oximeters during outpatient care within Cape Town, South Africa. This objective will be achieved through generating evidence on how, why, for whom, to what extent and at what cost can paediatric pulse oximetry devices improve the management of hypoxemic children. This will be done with two inter-linked studies: - Aim 1: Determine the impact of two novel paediatric pulse oximeter devices on the correct management of hypoxaemia. If the investigators find these devices improve healthcare worker assessments and decision making, it could improve clinical outcomes for children in low-resource contexts. - Aim 2: Describe the burden of hypoxaemia and risks for mortality amongst children presenting with acute respiratory infections in a low-resource setting in Cape Town. By establishing the burden and need, a clearer investment case for pulse oximetry can be made for this context.
Status | Not yet recruiting |
Enrollment | 2160 |
Est. completion date | February 28, 2026 |
Est. primary completion date | February 28, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Months to 59 Months |
Eligibility | Inclusion Criteria: - 0-59 months of age inclusive - presenting to care for an acute condition the includes observed and/or caregiver history of either cough and/or difficult breathing - residing in clinic catchment area - caregiver agrees to provide contact details including phone number and/or residential address - caregiver agrees to be contacted after two weeks by the study staff - caregiver is able and willing to provide written informed consent Exclusion Criteria: - 60 months of age or older - presenting to care for a non-acute condition or an acute condition that does not include either observed or caregiver history of cough and/or difficult breathing - does not reside in the clinic catchment area - caregiver does not agree to provide contact details - caregiver does not agree to be contact by study staff after two weeks - caregiver unable to provide written informed consent |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Johns Hopkins University | Baylor College of Medicine, Karolinska Institutet, University of Stellenbosch |
GBD 2019 Under-5 Mortality Collaborators. Global, regional, and national progress towards Sustainable Development Goal 3.2 for neonatal and child health: all-cause and cause-specific mortality findings from the Global Burden of Disease Study 2019. Lancet. 2021 Sep 4;398(10303):870-905. doi: 10.1016/S0140-6736(21)01207-1. Epub 2021 Aug 17. — View Citation
Glasgow RE, Harden SM, Gaglio B, Rabin B, Smith ML, Porter GC, Ory MG, Estabrooks PA. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health. 2019 Mar 29;7:64. doi: 10.3389/fpubh.2019.00064. eCollection 2019. — View Citation
King C, Boyd N, Walker I, Zadutsa B, Baqui AH, Ahmed S, Islam M, Kainja E, Nambiar B, Wilson I, McCollum ED. Opportunities and barriers in paediatric pulse oximetry for pneumonia in low-resource clinical settings: a qualitative evaluation from Malawi and Bangladesh. BMJ Open. 2018 Jan 30;8(1):e019177. doi: 10.1136/bmjopen-2017-019177. — View Citation
Lazzerini M, Sonego M, Pellegrin MC. Hypoxaemia as a Mortality Risk Factor in Acute Lower Respiratory Infections in Children in Low and Middle-Income Countries: Systematic Review and Meta-Analysis. PLoS One. 2015 Sep 15;10(9):e0136166. doi: 10.1371/journal.pone.0136166. eCollection 2015. — View Citation
McCollum ED, King C, Deula R, Zadutsa B, Mankhambo L, Nambiar B, Makwenda C, Masache G, Lufesi N, Mwansambo C, Costello A, Colbourn T. Pulse oximetry for children with pneumonia treated as outpatients in rural Malawi. Bull World Health Organ. 2016 Dec 1;94(12):893-902. doi: 10.2471/BLT.16.173401. Epub 2016 Oct 11. Erratum In: Bull World Health Organ. 2017 Jan 1;95(1):81. — View Citation
McCollum ED, King C, Hammitt LL, Ginsburg AS, Colbourn T, Baqui AH, O'Brien KL. Reduction of childhood pneumonia mortality in the Sustainable Development era. Lancet Respir Med. 2016 Dec;4(12):932-933. doi: 10.1016/S2213-2600(16)30371-X. Epub 2016 Nov 12. No abstract available. — View Citation
Rahman AE, Hossain AT, Nair H, Chisti MJ, Dockrell D, Arifeen SE, Campbell H. Prevalence of hypoxaemia in children with pneumonia in low-income and middle-income countries: a systematic review and meta-analysis. Lancet Glob Health. 2022 Mar;10(3):e348-e359. doi: 10.1016/S2214-109X(21)00586-6. — View Citation
Reiner RC, Welgan CA, Casey DC, Troeger CE, Baumann MM, Nguyen QP, Swartz SJ, Blacker BF, Deshpande A, Mosser JF, Osgood-Zimmerman AE, Earl L, Marczak LB, Munro SB, Miller-Petrie MK, Rodgers Kemp G, Frostad J, Wiens KE, Lindstedt PA, Pigott DM, Dwyer-Lindgren L, Ross JM, Burstein R, Graetz N, Rao PC, Khalil IA, Davis Weaver N, Ray SE, Davis I, Farag T, Brady OJ, Kraemer MUG, Smith DL, Bhatt S, Weiss DJ, Gething PW, Kassebaum NJ, Mokdad AH, Murray CJL, Hay SI. Identifying residual hotspots and mapping lower respiratory infection morbidity and mortality in African children from 2000 to 2017. Nat Microbiol. 2019 Dec;4(12):2310-2318. doi: 10.1038/s41564-019-0562-y. Epub 2019 Sep 30. — View Citation
Richards D, Hunter L, Forey K, et al. Demographics and predictors of mortality in children undergoing resuscitation at Khayelitsha Hospital, Western Cape, South Africa. SAJCH South African Journal of Child Health 2018; 12: 127-31
WHO. World Health Organization Integrated Management of Childhood Illness ( IMCI ) Chart Booklet-Standard. Geneva (Switzerland): World Health Organization 2014; : 1-80.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Correct management of oxygen saturation | The numerator is the number of children who have a biologically plausible oxygen saturation measurement achieved, the oxygen saturation measurement is documented by the healthcare worker, and an appropriate referral recommendation has been provided by the healthcare worker. All three of these conditions need to be met to be considered correct management. The denominator will be all the eligible recruited children, with suspected LRI. | Day 1 after enrollment | |
Secondary | Oxygen saturation measurement acceptance | The proportion of caregivers who permit the healthcare worker to measure the oxygen saturation on the child. | Day 1 after enrollment | |
Secondary | Referral completion | Amongst children with an oxygen saturation <94%, the proportion who present to the referral hospital within 48 hours. | Day 3 after enrollment | |
Secondary | Proportion Who Receive Oxygen treatment | Amongst children with an oxygen saturation <94%, the proportion who present to the referral hospital within 48 hours and are given oxygen treatment. | Day 3 after enrollment | |
Secondary | Mortality | The proportion of children who died from any cause by day 15 of enrollment. | Day 15 after enrollment | |
Secondary | Hypoxemic (<94%) mortality | The proportion of children with an oxygen saturation <94% who died by day 15 of enrollment. | Day 15 after enrollment | |
Secondary | Hypoxemic (<90%) mortality | The proportion of children with an oxygen saturation <90% who died by day 15 of enrollment. | Day 15 after enrollment |
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