ABSTRACT
Acute kidney injury (AKI) occurs in nearly 30% of sick neonates. Chronic kidney disease (CKD) can be detected in certain populations of sick neonates as early as 2 years. AKI is often part of a multisystem syndrome that negatively impacts developing organs resulting in short- and long-term pulmonary, neurodevelopmental, and cardiovascular morbidities. It is critical to incorporate kidney-related data into neonatal clinical trials in a uniform manner to better understand how neonatal AKI or CKD could affect an outcome of interest. Here, we provide expert opinion recommendations and rationales to support the inclusion of short- and long-term neonatal kidney outcomes using a tiered approach based on study design: (1) observational studies (prospective or retrospective) limited to data available within a center's standard practice, (2) observational studies involving prospective data collection where prespecified kidney outcomes are included in the design, (3) interventional studies with non-nephrotoxic agents, and (4) interventional studies with known nephrotoxic agents. We also provide recommendations for biospecimen collection to facilitate ancillary kidney specific research initiatives. This approach balances the costs of AKI and CKD ascertainment with knowledge gained. We advocate that kidney outcomes be included routinely in neonatal clinical study design. Consistent incorporation of kidney outcomes across studies will increase our knowledge of neonatal morbidity.
ABSTRACT
Background & objectives: Antibiotic administration within one hour of presentation is a standard of care goal in the treatment of febrile neutropenia (FN). The objective of this study was to find the proportion of children with FN who had a time to antibiotic administration (TTA) of ≤60 min and evaluate causes for delay. Methods: A prospective analysis of children presenting with FN was carried out. The primary outcome was the proportion of patients who received antibiotics within one hour of triage. Predictor variables included the place of presentation, time and day of the week. A root cause analysis was done for delayed TTA. Results: A total of 211 children (mean age: 6 yr) with FN were evaluated for TTA. The primary outcome of TTA, (≤60 min) was achieved in 66 per cent children. The odds of delayed TTA were lower when patients were evaluated in the night. Odds of delayed TTA were higher in patients who had no focus of infection, when assessed in the oncology daycare and when assessed over the weekend, but none were statistically significant. Waiting for blood results (30%), delay in preparing antibiotics (21%) and delay in allotting bed (30%) were significant causes for delay. Interpretation & conclusions: Two-thirds of the patients achieved the target TTA of ≤60 min. Patients seen during the daytime and on weekends had a delay in TTA compared to those presenting at the evening or night or weekdays. Children with a focus for fever received antibiotics earlier. Logistics for admission and awaiting blood counts were chief causes for delay.
