Safety and effectiveness of a non-electric infant warmer for hypothermia in Rwanda: A cluster-randomized stepped-wedge trial.

BACKGROUND: Neonatal hypothermia is a common source of morbidity and mortality in low resource settings. We developed the Dream Warmer, a low cost, re-usable non-electric infant warmer to prevent and treat hypothermia. METHODS: We conducted a cluster-randomized stepped-wedge trial. The primary aim was to assess the effect on overall euthermia rates of introducing the warmer compared to standard of care in rural Rwandan hospitals. The secondary aims were to assess effects of warmer introduction on mortality, as well as the safety and feasibility of the warmer. Ten district hospitals participated in the study from November 19th 2019 to July 15th 2020. Patients were eligible to use the warmer if they were 1) hypothermic (temp < 36·5 °C) or 2) or at risk of hypothermia (weight < 2·5 kg or estimated post menstrual age < 35 weeks) when Kangaroo Mother Care was not available. An encounter was defined as the data from an individual infant on a single day. Trial of a Non Electric Infant Warmer for Prevention and Treatment of Hypothermia in Rwanda [NCT03890211]. FINDINGS: Over the study period, 3179 patients were enrolled across the ten neonatal wards, yielding 12,748 encounters; 464 unique infants used the warmer 892 times, 79% eligible due to hypothermia. Because of limited study nurse resources, the warmer was used in only 18% of eligible encounters. Despite this low rate of warmer use, the rate of euthermia rose from 51% (95% CI 50-52%) of encounters pre-intervention to 67% (66-68%) post-intervention; p < 0·0001. Among the encounters in which the warmer was used, only 11% (9-13%) remained hypothermic. While mortality rates pre- and post-intervention did not change, mortality rate among those who used the warmer was significantly lower than among those who did not (0·9% vs 2·8%, p = 0·01). Use of the warmer did not affect hyperthermia rates. There were no safety concerns or instances of incorrect warmer use. INTERPRETATION: Introduction of the warmer increased rates of euthermia with no associated safety concerns.

Performance of a Nonelectric Infant Warmer in Rwandan Health Centers.

Background. Neonatal hypothermia remains a challenge in resource-limited settings. Methods. We conducted a prospective mixed-methods cohort study in rural Rwandan health centers to assess the performance of an infant warmer we designed for low-resource settings. All hypothermic infants were eligible for enrollment. Outcomes. Safety: incidence of adverse reactions. Effectiveness: attainment of euthermia, rate of temperature rise. Feasibility: correct use of warmer, signs of wear. Interviews of caregivers and nurses. Findings. Of 102 encounters, there were no adverse reactions. Of 80 encounters for hypothermia when infants on warmer for ≥1 hour, 79 achieved euthermia; 73 in ≤2 hours. Of the 80 encounters, 64 had temperature rise ≥0.5°C/h. Of the 102 encounters, there were no instances of the warmer being prepared, used, or cleaned incorrectly. Five out of the 12 warmers exhibited wear. Interview participants were predominantly positive; some found time for readiness of warmer challenging. Interpretation. The warmer performed well. It is appropriate to study in larger scale.

Outcomes of Low-Intensity Treatment of Acute Lymphoblastic Leukemia at Butaro Cancer Center of Excellence in Rwanda.

PURPOSE: Children with acute lymphoblastic leukemia (ALL) in low-income countries have disproportionately lower cure rates than those in high-income countries. At Butaro Cancer Center of Excellence (BCCOE), physicians treated patients with ALL with the first arm of the Hunger Protocol, a graduated-intensity method tailored for resource-limited settings. This article provides the first published outcomes, to our knowledge, of patients with ALL treated with this protocol. METHODS: This is a retrospective descriptive study of patients with ALL enrolled at BCCOE from July 1, 2012 to June 30, 2014; data were collected through December 31, 2015. Descriptive statistics were used to calculate patient demographics, disease characteristics, and outcomes; event-free survival was assessed at 2 years using the Kaplan-Meier method. RESULTS: Forty-two consecutive patients with ALL were included. At the end of the study period, 19% (eight) were alive without evidence of relapse: three completed treatment and five were continuing treatment. Among the remaining patients, 71% (30) had died and 10% (four) were lost to follow-up. A total of 83% (25) of the deaths were disease related, 3% (one) treatment-related, and 13% (four) unclear. Event-free survival was 22% (95% CI, 11% to 36%), considering lost to follow-up as an event, and 26% (95% CI, 13% to 41%) if lost to follow-up is censored. CONCLUSION: As expected, relapse was the major cause of failure with this low-intensity regimen. However, toxicity was acceptably low, and BCCOE has decided to advance to intensity level 2. These results reflect the necessity of a data-driven approach and a continual improvement process to care for complex patients in resource-constrained settings.

Predictors of Suboptimal Follow-up in Pediatric Cancer Survivors.

Attendance to follow-up care after completion of cancer treatment is an understudied area. We examined demographic, clinical, and socioeconomic predictors of follow-up by pediatric cancer patients at a large center in 442 newly diagnosed patients using multivariable logistic regression analyses. Patients who did not return to clinic for at least 1000 days were considered lost to follow-up. Two hundred forty-two (54.8%) patients were lost. In multivariable analyses, the following variables were independent predictors of being lost to follow-up: treatment with surgery alone (odds ratio [OR]=6.7; 95% confidence interval [CI], 3.1-14.9), older age at diagnosis (reference, 0 to 4; ages, 5 to 9: OR=1.8, 95% CI, 1.1-3; ages, 10 to 14: OR=3.3; CI, 1.8-6.1; and ages, 15 and above: OR=4.8; CI, 2.1-11.7), lack of history of stem cell transplantation (OR=2, 95% CI, 1.04-3.7) and lack of insurance (OR=3.4; CI, 1.2-9.2). Hispanic patients had the best follow-up rates (53.7%) compared to whites and blacks (P=0.03). Attendance to long-term follow-up care is suboptimal in childhood cancer survivors. Predictors that were associated with nonattendance can be used to design targeted interventions to improve follow-up care for survivors of pediatric cancer.

Treating Nephroblastoma in Rwanda: Using International Society of Pediatric Oncology Guidelines in a Novel Oncologic Care Model.

PURPOSE: Success in treating nephroblastoma in high-income countries has been transferred to some resource-constrained settings; multicenter studies report disease-free survival of greater than 70%. However, few reports present care models with rural-based components, care tasks shifted to internists and pediatricians, and data collection structured for monitoring and evaluation. Here, we report clinical outcomes and protocol compliance for patients with nephroblastoma evaluated at Butaro Cancer Center of Excellence in Rwanda. PATIENTS AND METHODS: This retrospective study reports the care of 53 patients evaluated between July 1, 2012, and June 30, 2014. Patients receiving less than half of their chemotherapy at Butaro Cancer Center of Excellence were excluded. RESULTS: Of the 53 patients included, 9.4% had stage I, 13.2% had stage II, 24.5% had stage III, 26.4% had stage IV, and 5.7% had stage V disease; the remaining 20.8% had unknown stage disease from inadequate work-up or unavailable surgical report. The incidence of neutropenia increased with treatment progression, and the greatest proportion of delays occurred during the surgical referral phase. At the end of the study period, 32.1% of patients (n = 17) remained alive after treatment; 24.5% (n = 13) remained alive while continuing treatment, including one patient with recurrent disease; 30.2% (n = 16) died; and 13.2% (n = 7) were lost to follow-up. CONCLUSION: Our findings confirm that nephroblastoma can be effectively treated in resource-constrained settings. Using an approach in which chemotherapy is delivered at a rural-based center by nononcologists and data are used for routine evaluation, care can be delivered in safe, novel ways. Protocol modifications to mitigate chemotherapy toxicities and strong communication between the multidisciplinary team members will likely minimize delays and further improve outcomes in similar settings.