Research Articles (Paediatrics and Child Health)
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- ItemThe incidence of retinoblastoma in South Africa : findings from the South African National Cancer Registry (2004–2018)(Taylor & Francis, 2022-12) Stuart, Kelsey V.; Shepherd, Daniel J.; Kruger, Mariana; Singh, ElviraABSTRACT: Purpose: To determine the frequency and incidence rate of retinoblastoma in children in South Africa from 2004 to 2018. Methods: Incident cases of histologically diagnosed retinoblastoma were identified from the South African National Cancer Registry. Crude incidence rates were calculated using national population data on children <15 years and live births. Incidence rates were stratified and compared by age, sex and population group. Direct age-standardised incidence rates and comparative incidence ratios were calculated. Results: The overall age-standardised incidence rate for children <15 years was 3.3 per million or 1 per 21 641 live births. Age-specific rates for children aged 0–4, 5–9 and 10–14 years were 7.7, 0.8 and 0.2 per million, respectively. There was no difference in incidence rates by sex. White children had a significantly higher incidence rate compared to other population groups, but this finding may be due to systemic biases introduced by access to healthcare in South Africa or study methodology. Conclusion: This is the largest study to provide population-based, histologically confirmed national estimates of retinoblastoma incidence from an African nation to date and affirms the need for high-quality cancer registries across the African continent.
- ItemPharmacokinetics and safety of the abacavir/lamivudine/lopinavir/ritonavir fixed-dose granule formulation (4-in-1) in neonates : PETITE study(Wolters Kluwer, 2022-03) Bekker, Adrie; Rabie, Helena; Salvadori, Nicolas; Du Toit, Samantha; Than-in-at, Kanchana; Groenewald, Marisa; Andrieux-Meyer, Isabelle; Kumar, Mukesh; Cressey, Ratchada; Nielsen, James; Capparelli, Edmund; Lallemant, Marc; Cotton, Mark F.; Cressey, Tim R.ABSTRACT: Background: Antiretroviral options for neonates (younger than 28 days) should be expanded. We evaluated the pharmacokinetics, safety, and acceptability of the "4-in-1" fixed-dose pediatric granule formulation of abacavir/lamivudine/lopinavir/ritonavir (30/15/40/10 mg) in neonates. Methods: The PETITE study is an ongoing phase I/II, open-label, single-arm, 2-stage trial conducted in South Africa. In stage 1, term neonates exposed to HIV on standard antiretroviral prophylaxis (nevirapine ± zidovudine) received single dose(s) of the 4-in-1 formulation, followed by intensive pharmacokinetic sampling and safety assessments. At each PK visit, blood was drawn after an observed dose at 1, 2, 4, 8, and 12 hours postdose. In this study, we have reported the planned interim pharmacokinetic and safety analysis after completion of the single-dose administration. Results: Sixteen neonates, with a median (range) birth weight of 3130 g (2790–3590 g), completed 24 pharmacokinetic visits. The 4-in-1 formulation imposed relatively high doses of abacavir [8.6 mg/kg (6.6–11.4)] and lamivudine [4.3 mg/kg (3.3–5.7)] but lower doses of lopinavir [11.5 mg/kg (8.8–15.2)]. The geometric means (GM, 90% CI) AUC0–12 of abacavir, lamivudine, and lopinavir were 29.87 (26.29–33.93), 12.61 (10.72–14.83), and 3.49 (2.13–5.72) µg.h/mL, respectively. Lopinavir GM AUC0–12 was below the predefined target (20–100 µg.h/mL), and ritonavir concentrations were only detectable in 4 of the 120 (3%) samples. No adverse events were related to study drugs. No neonate had difficulty swallowing the 4-in-1 formulation. Conclusions: The high doses of abacavir and lamivudine (in mg/kg) and AUCs were safe, and the formulation was well tolerated; however, lopinavir/ritonavir exposures were extremely low, preventing its use in neonates use in neonates. Alternative pediatric solid antiretroviral formulations must be studied in neonates.
- ItemMaternal and infant outcomes among pregnant women treated for multidrug/rifampicin-resistant tuberculosis in South Africa(Oxford University Press, 2021-04) Loveday, Marian; Hughes, Jennifer; Sunkari, Babu; Master, Iqbal; Hlangu, Sindisiwe; Reddy, Tarylee; Chotoo, Sunitha; Green, Nathan; Seddon, James ABackground Data on safety and efficacy of second-line tuberculosis drugs in pregnant women and their infants are severely limited due to exclusion from clinical trials and expanded access programs. Methods Pregnant women starting treatment for multidrug/rifampicin-resistant (MDR/RR)-tuberculosis at King Dinuzulu Hospital in KwaZulu-Natal, South Africa, from 1 January 2013 to 31 December 2017, were included. We conducted a record review to describe maternal treatment and pregnancy outcomes, and a clinical assessment to describe infant outcomes. Results Of 108 pregnant women treated for MDR/RR-tuberculosis, 88 (81%) were living with human immunodeficiency virus.. Favorable MDR/RR-tuberculosis treatment outcomes were reported in 72 (67%) women. Ninety-nine (91%) of the 109 babies were born alive, but overall, 52 (48%) women had unfavorable pregnancy outcomes. Fifty-eight (54%) women received bedaquiline, and 49 (45%) babies were exposed to bedaquiline in utero. Low birth weight was reported in more babies exposed to bedaquiline compared to babies not exposed (45% vs 26%; P = .034). In multivariate analyses, bedaquiline and levofloxacin, drugs often used in combination, were both independently associated with increased risk of low birth weight. Of the 86 children evaluated at 12 months, 72 (84%) had favorable outcomes; 88% of babies exposed to bedaquiline were thriving and developing normally compared to 82% of the babies not exposed. Conclusions MDR/RR-tuberculosis treatment outcomes among pregnant women were comparable to nonpregnant women. Although more babies exposed to bedaquiline were of low birth weight, over 80% had gained weight and were developing normally at 1 year.
- ItemAutonomy in asthma management(Allergy Society of South Africa (ALLSA), 2021-12) Kling, SharonThe principle of autonomy is one of the pillars of the four principles approach to medical ethics. Autonomous patients should be respected and have the right and the freedom to make their own decisions regarding their healthcare. This individualistic view of autonomy is particularly prevalent in Western cultures and clinical practice; a relational type of autonomy prevails in cultures which are communitarian in their approach. Autonomy and shared decision making are important concepts in managing asthma.
- ItemLife-threatening asthma in children: a review(Allergy Society of South Africa (ALLSA), 2021-12-01) White, Debbie A; White, William A; Kling, SharonWe present a case of a child presenting with well-described but poorly recognised symptoms of life-threatening asthma that were initially missed. We present a management protocol for life-threatening asthma, for which evidence in the literature is lacking.