ABSTRACT
Neonatal sepsis is a significant cause of mortality and morbidity in low- and middle-income countries. To deliver high-quality data studies and inform future trials, it is crucial to understand the challenges encountered when managing global multi-centre research studies and to identify solutions that can feasibly be implemented in these settings. This paper provides an overview of the complexities faced by diverse research teams in different countries and regions, together with actions implemented to achieve pragmatic study management of a large multi-centre observational study of neonatal sepsis. We discuss specific considerations for enrolling sites with different approval processes and varied research experience, structures, and training. Implementing a flexible recruitment strategy and providing ongoing training were necessary to overcome these challenges. We emphasize the attention that must be given to designing the database and monitoring plans. Extensive data collection tools, complex databases, tight timelines, and stringent monitoring arrangements can be problematic and might put the study at risk. Finally, we discuss the complexities added when collecting and shipping isolates and the importance of having a robust central management team and interdisciplinary collaborators able to adapt easily and make swift decisions to deliver the study on time and to target. With pragmatic approaches, appropriate training, and good communication, these challenges can be overcome to deliver high-quality data from a complex study in challenging settings through a collaborative research network.
ABSTRACT
Background: Improved survival in extremely low birth weight infants (ELBWI) in Sub-Saharan Africa has raised the question whether these survivors have an increased chance of adverse neurodevelopmental outcomes. Objectives: To describe neurodevelopmental outcomes of ELBWI in a neonatal unit in South Africa. Methods: This was a prospective follow-up study. All ELBWI who survived to discharge between 1 July 2013 and 31 December 2017 were invited to attend the clinic. Bayley Scales of Infant and Toddler Development (version III) were conducted at 9 to 12 months and 18 to 24 months. Results: There were 723 ELBWI admissions during the study period, 292 (40.4%) survived to hospital discharge and 85/292 (29.1%) attended the neonatal follow up clinic. The mean birth weight was 857.7 g (95% CI: 838.2-877.2) and the mean gestational age was 27.5 weeks (95% CI 27.1-27.9). None of the infants had any major complication of prematurity. A total of 76/85 (89.4%) of the infants had a Bayley-III assessment at a mean corrected age of 17.21 months (95% CI: 16.2-18.3). The mean composite scores for cognition were 98.4 (95% CI 95.1-101.7), language 89.9 (95% CI 87.3-92.5) and motor 97.6 (95% CI 94.5-100.6). All mean scores fell within the normal range, The study found 28 (36.8%) infants to be "at risk" for neurodevelopmental delay. Conclusion: Our study demonstrates good neurodevelopmental outcome in a small group of surviving ELBWI, but these results must be interpreted in the context of the high mortality in this group of infants.
ABSTRACT
Background. Chronic lung disease (CLD) remains a significant morbidity in preterm babies despite advances in neonatal care. The use of postnatal corticosteroids (PNCSs) to treat CLD remains controversial.Objectives. To describe the clinical characteristics of babies with CLD at Charlotte Maxeke Johannesburg Academic Hospital (CMJAH) and to explore the use of PNCSs for the prevention and treatment of CLD.Methods. This was a 2-year retrospective review of neonates admitted to CMJAH. Neonates who were in hospital for =28 days were included. Comparisons were made between neonates with evolving CLD and those with no CLD.Results. A total of 485 neonates were analysed: 237 had evolving CLD and 245 did not have CLD. Overall incidence of evolving CLD was 5%. More neonates with CLD than those without CLD needed resuscitation at birth (48.5% v. 39.8%; p=0.02) and had low 5-minute Apgar scores (17.2% v. 10.6%; p=0.001). Neonates with CLD had increased prevalence of patent ductus arteriosus (30.4% v. 7.7%; p=0.001) and late-onset sepsis (56.5% v. 23.6%; p=0.001). The mortality rate was also higher in CLD babies (10.2 v. 2.4%; p=0.001). Necrotising enterocolitis (NEC) (29.2% v. 8%; p=0.005) and sepsis (83.3% v. 53.8%; p=0.008) were associated with increased mortality. The use of PNCSs was associated with less NEC (3.5% v. 17.2%; p=0.001) and improved survival (95.6% v. 81.7%; p=0.001).Conclusions. CLD remains a common morbidity in neonates despite advances in neonatal care. The use of PNCSs was shown to have short-term benefits. To get the most out of PNCS use for CLD; further studies need to be conducted to determine the safest type of steroid; safe doses and the duration of treatment
