An institution-based retrospective follow-up study design was conducted among a cohort of neonates in the previous two consecutive years, from January 1, 2020 to December 30, 2022.
Study area
The study was conducted in the Northwest Amhara region's comprehensive specialized hospitals. In the Northwest Amhara region, there are three comprehensive specialized hospitals (CSH). Those are the University of Gondar CSH, Tibebe Ghion CSH, and Debre Tabor CSH. UoGCSH is located in Gondar town and has an average annual admission of 4560 and an average monthly admission of 380 neonates. Tibebe Ghion CSH is found in Bahir Dar city. These hospitals have an average annual neonatal admission of 1920 neonates and an average monthly admission of 160, respectively. Debre Tabor CSH, which is found in Debre Tabor town, has an average annual neonatal admission of 1560 and an average monthly admission of 130. These hospitals are the final referral choice for other health institutions. Those hospitals have NICUs with mixed health professionals (neonatal and comprehensive nurses, general practitioners, pediatricians, and other staff). The major services in the NICU include general neonatal care services, blood and exchange transfusions, phototherapy, and ventilation support such as continuous positive air pressure
Source and Study Population
Source populations
The source population included all neonates admitted to the NICUs of the three Amhara Region hospitals, Comprehensive Specialized Hospitals Northwest Ethiopia.
Study populations
From January 1, 2020, to December 30, 2022, all neonates admitted to the three selected comprehensive specialized hospitals in Amhara Region, Northwest Ethiopia.
Eligibility criteria
All neonates’ medical cards documented in the previous two years from the study period were recruited and incomplete cards were excluded.
Sample size determination and sampling procedures
Sample size determination
The sample size was calculated using the single population proportion formula; considering the following: 95% confidence interval(CI), 50% proportion of neonates with acute kidney injury and 5% margin of error. The required sample was calculated using the following formula.
By adding a 10 % chart attrition, a total of 634 charts were included in the study.
Sampling procedures
There are three comprehensive specialized hospitals in the Amhara region. Based on the data, UoGCSH has 9120/2 years, TGCSH has 3840/2 years and DTCSH has 3120/2 years, 16,080 newborns were admitted to the hospitals from January 1, 2020 to December 30, 2022.
A total of 634 samples were selected from 16,080 newborns. From the final sample size, a proportional allocation was made for each hospital. The sampling frame was established after the identification numbers of the admitted patients were recorded from the registration book. After identifying patients who met the inclusion criteria, study participants were selected by simple random sampling using computer-generated methods.
Study Variables
Dependent variable
Incidence of Neonatal Acute kidney injury
Independent variables
Socio-demographic maternal and neonatal
Age, sex, gestational age, and Age of the mother, birth weight, weight of Gestation
Maternally related factors
Placental hemorrhage, prenatal steroids, Prolonged rupture of membranes (PROM), ANC, Placental hemorrhage, Polyhydramnios, oligohydramnios, Place of delivery, preeclampsia, gestational hypertension, DM, Prolonged labor, and Parity),
Clinical factors
Neonatal Sepsis, necrotizing enterocolitis, MAS, Shock, RDS, IVH, Low APGAR, hypoxic-ischemic encephalopathy (HIE) Congenital heart disease (CHD) and Persistent pulmonary hypertension (PPH)Sodium level, potassium level
Operational definition
Acute kidney injury: is defined as a serum creatinine level of 1.5 mg/dl or an increase in serum creatinine of 0.2 to 0.3 mg/dl within 48 hours (20).
Censored: newborn who did not develop the outcome of interest (AKI) until the end of the follow-up period or lost to follow-up, recovery from illness, discharged against medical advice, or transfer out to other health institutions without knowing the outcome.
Outcome: newborn who were develop the outcome during the study period
Data collection tools
A pretested checklist was used to collect the required data from patients' medical records. Consistency was checked. Data were collected by reviewing the complete patient chart for the last two consecutive years of the study period. AKI was confirmed by reviewing the medical records.
Data quality control
Data quality was ensured by developing appropriate data abstraction tools. The checklist was evaluated by experienced researchers. The data collection instrument was pretested on 5% of the sample size. Both data collectors and supervisors were thoroughly trained on the data collection checklist and the data collection process. During data collection, strict monitoring and supervision was performed by the supervisors and the investigator. Data entry was also performed using Epi data 4.6 software.
Data processing, analysis, and presentation:
After data collection, the data were cleaned, edited, and coded. Errors identified at this time were corrected after a review of the original data using the code numbers. Data were entered using Epi-Data version 4.6 and analyzed using STATA 14 statistical software. Descriptive statistics were performed using mean, frequency, percentage, tables, and numbers. In addition, a log-rank test was used to compare AKI survival among different categorical predictor variables. The variance inflation factor (VIF = 1.83) was used to test the multicollinearity test showing the association between predictor variables.at risk for follow-up and reported per 100-person day. Kaplan-Meir was used to estimate mean survival.
Based on the Cox proportional hazard assumption test using Schoenfeld residuals and a log-log plot (graphical), all covariates met the assumption, and the overall global model met the proportional hazard assumption (global test, p = 0.6638). The Cox-Snell residual test was used to test goodness of fit. A 95% confidence interval (CI) for the adjusted hazard ratio (AHR) was estimated to determine the strength of the association. Statistical significance between predictors and AKI was determined with a P value of 0.05.