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Article

Neutrophil Gelatinase-Associated Lipocalin as a Useful Modality in Early Acute Kidney Injury Detection Amongst Low-Birth-Weight Neonates

by
Tetty Yuniati
1,
Fiva Aprilia Kadi
1,
Aris Primadi
1,
Dwi Oktari Erfanti
2,
Johanes Edy Siswanto
3,4 and
Ahmedz Widiasta
5,*
1
Neonatology Division, Child Health Department, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin General Hospital, Bandung 40161, Indonesia
2
Neonatology Division, Child Health Department, Faculty of Medicine, Universitas Padjadjaran Hospital, Jatinangor 45363, Indonesia
3
Department of Neonatology, Harapan Kita National Woman and Children’s Hospital, Jakarta 11420, Indonesia
4
Faculty of Medicine, Pelita Harapan University, Tangerang 15811, Indonesia
5
Nephrology Division, Child Health Department, Faculty of Medicine, Universitas Padjadjaran, Hasan Sadikin General Hospital, Bandung 40161, Indonesia
*
Author to whom correspondence should be addressed.
Kidney Dial. 2026, 6(1), 14; https://doi.org/10.3390/kidneydial6010014
Submission received: 10 December 2025 / Revised: 9 February 2026 / Accepted: 13 February 2026 / Published: 25 February 2026
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Abstract

Background: Chronic kidney disease (CKD) and hypertension in adolescence and young adulthood are predisposing factors for cardiovascular and neurological diseases later in life. Serum creatinine levels have been routinely used as a daily practice modality for detecting acute kidney injury (AKI) in patients of all ages, but unfortunately have some limitations, such as their delayed increase during AKI events. An earlier biomarker is needed to detect AKI, notably in the neonatal period. In the present study, we aimed to determine whether neutrophil gelatinase-associated lipocalin (NGAL) could be used as a modality in detecting AKI, not only in children and adults, but also in neonates. Methods: We conducted a prospective-cohort study on preterm neonates with a gestational age of 28–34 weeks at Hasan Sadikin General Hospital, Bandung, and performed serum NGAL and creatinine measurements. Spearman’s rank correlation was used to determine the association between serum NGAL levels and AKI during the first 48 h in these neonates. Serum NGAL was measured using the Elabscience® Human NGAL ELISA kit; NGAL positivity was defined as serum NGAL > 150 ng/mL for exploratory classification. Results: Serum NGAL measurement showed a better positivity rate in detecting early AKI in neonates than creatinine (KDIGO and nRIFLE), with values of 81.8, 24.7, and 10.4, respectively. Conclusions: NGAL can be used as a modality for detecting AKI earlier in neonates.

1. Introduction

Chronic kidney disease (CKD) is a non-communicable disease (NCD) that not only affects adults but also children and babies, and can cause decreased quality of life and increased mortality. CKD and hypertension in adolescence and young adulthood are predisposing factors for cardiovascular and neurological diseases later in life [1,2,3,4].
Early screening for CKD will provide a better prognosis, but requires appropriate, careful, and continuous modalities [5,6], with those currently established in developed countries including urinary screening and blood pressure measurements. Underdeveloped nephrons also play a role in CKD incidence [5], and disrupted nephron development is common in premature births; in premature conditions, the number of nephrons remains insufficient, and hypertension and glomerular hyperfiltration often occur. Monitoring premature babies therefore requires uniformity so that potential incidents of acute kidney disease (AKD) and CKD are discovered promptly; early acute kidney injury (AKI) diagnosis is important in preventing AKD [7,8]. Proper AKI management could prevent AKD and CKD [9,10,11,12].
In daily practice, premature babies require minimal handling during treatment; therefore, urinary catheterization is not recommended, because it can cause iatrogenic urinary tract infection (UTI), which causes difficulties in detecting oliguria in neonates. The modality commonly used to screen for AKI in neonates is SCr measurement, though this is sometimes only meaningful if AKI has occurred for >48 h, causing delayed treatment and affecting the prognosis. In adult and pediatric populations, there are other promising modalities for early AKI detection, including examining cystatin C, neutrophil gelatinase-associated lipocalin (NGAL), and kidney injury molecule-1 (KIM-1) [13,14,15]. These protein examinations are not yet common, and government and hospital policies still need to be prepared. The government requires valid research data to examine the expression of these proteins.
NGAL, KIM-1, and cystatin C levels in neonates during early AKI detection have not been well researched. Studies on IL-18 in neonates have been published; however, procuring IL-18 kits is expensive. Therefore, they are difficult to implement in developing countries. Oligonephronemia-related prematurity is a predisposing factor for CKD in both adulthood and childhood [5]. It is necessary to conduct research to determine the relationship between NGAL and serum creatinine in AKI in the first 24 h of birth, in order to determine the best modality for early AKI detection in at-risk neonates. In addition, evidence of serum NGAL being used to monitor AKI treatment in LBW neonates is needed. Although research has been published on the significance of serum NGAL levels in detecting AKI early in neonates, some controversies remain [5,16,17,18,19,20]. In addition, urinary and serum NGAL have almost the same significance; therefore, research on the use of the latter in monitoring neonatal AKI is necessary. In this study, we aimed to determine whether NGAL can be used as a modality for early detection and monitoring of improvement in AKI amongst LBW neonates.

2. Materials and Methods

2.1. Study Design, Setting, and Participant

A prospective-cohort study was conducted from January to July 2024 in Hasan Sadikin General Hospital, Bandung, West Java.

2.2. Inclusion and Exclusion Criteria

The inclusion criteria were preterm infants born at 28–34 weeks of gestational age without any dehydration, while those with congenital heart disease, infant lupus, congenital anomalies of the kidney and urinary tract (CAKUT), and sepsis were excluded to avoid bias from additional postrenal and prerenal AKI risk factors.

2.3. Variables

Preterm infants met the inclusion criteria for urinary production monitoring. NGAL levels and SCr levels were measured within the first 24 h and repeated on day 3. Serum NGAL was measured using the ElabscienceR Human NGAL ELISA kit. NGAL positivity was defined as serum NGAL > 150 ng/mL.

2.4. Statistical Methods

Statistical analysis was conducted with the Kolmogorov–Smirnov test of normality on numerical data; the Wilcoxon test of differences in changes in NGAL, SCr, and urine volume between D1 and D3; Cochran’s Q test to determine the differences in positivity rate between modalities; and Spearman’s rank test to determine the correlation between SCr and urine volume with NGAL. In this manuscript, the term “positivity rate” refers to the proportion of the total cohort that met each diagnostic criterion (i.e., classified as AKI by NGAL, KDIGO or nRIFLE) rather than a true positivity rate against a gold standard. Characteristic data are presented descriptively for the categorical data using numbers and percentages, while numerical data are presented as the median, IQR, and minimum maximum, because the data are not normally distributed. The confidence interval is 95% with a significance level of 5% (p < 0.05), and the analysis was performed using SPSS version 27.0.
This research project was approved by the institutional review boards at Hasan Sadikin General Hospital; all methods were performed in accordance with the relevant guidelines and regulations.

3. Results

3.1. Participants/Descriptive Data

This study included 77 low-birth-weight neonates with varying demographic and clinical characteristics (Table 1). Based on the KDIGO, NGAL, and nRIFLE criteria, AKI was found in 19, 63, and 8 neonates, respectively. Of the total subjects, the majority were male (58.4%), the median neonate gestational age was 33 weeks, and there was a gestational age range of 28–34 weeks, indicating that most subjects were born prematurely. The neonate birth weights in this study varied, with a median of 1600 g in the range of 750–2150 g, indicating that the subjects consisted of neonates with birth weights that ranged from very low to close to normal, and most were born spontaneously (54.5%). The neonates’ health conditions after birth were assessed using the APGAR score, with a median of 7 in the first minute, 8 in the second minute, and 9 in the fifth minute, which showed an improvement in condition over time. As many as 27.3% of mothers who gave birth experienced hypertension during pregnancy, which may have contributed to premature birth and the low birth weight in neonates. In this study, we provide important insights into the demographic and clinical characteristics of LBW neonates, which may be useful for developing better treatment and intervention strategies in the future.

3.2. Outcomes

Based on the analysis in Table 2, which presents changes in urine volume, creatinine levels, and NGAL between the first (D1) and third day (D3) in low-birth-weight neonates, several important conclusions can be drawn: (1) There was a significant increase in urine volume from D1 to D3, with the median increasing from 1.4 mL/kg/hour (D1) to 3.0 mL/kg/hour (D3), indicating a significant increase in urinary output, which may reflect changes in kidney function or the body’s response to clinical intervention. A p-value of <0.001 confirmed that this change was statistically significant. (2) Creatinine, a traditional marker of kidney function, did not show significant changes between D1 and D3. Median creatinine levels changed only slightly from 0.76 mg/dL in D1 to 0.74 mg/dL in D3, with a p-value of 0.655, indicating that this change was not statistically significant. This indicates that kidney filtering function remained stable during this observation period. (3) There was a significant increase in NGAL levels from D1 to D3, with the median increasing from 168 ng/mL on D1 to 507 ng/mL on D3. This increase, which was also statistically significant (p-value < 0.001), indicated that NGAL responded more quickly to kidney changes or stress than creatinine.
It can be concluded that in low-birth-weight neonates, there was a significant increase in urine volume and NGAL levels from the first to the third day. The more rapid and significant increase in NGAL compared to creatinine suggests that the former is a more responsive and possibly more effective modality for early detection of kidney damage or stress. Meanwhile, the creatinine level stability showed that, despite changes in kidney function detected by NGAL, the kidney filtering function measured through creatinine remained stable during this observation period. These changes need to be considered in low-birth-weight neonate clinical monitoring, especially in the context of early detection and treatment of kidney damage.

4. Discussion

4.1. Acute Kidney Injury Positivity Rate Using NGAL, KDIGO, and nRIFLE

In this study, we evaluated the acute kidney injury (AKI) positivity rate in low-birth-weight neonates using three different diagnostic modalities: NGAL, KDIGO, and nRIFLE (Table 3). The results obtained show significant differences in each modality’s positivity in detecting AKI.
NGAL emerged as the most sensitive diagnostic modality, with an AKI positivity rate of 81.8%. A 95% confidence interval range (71.8% to 88.8%) showed that NGAL consistently detected AKI in the majority of neonates examined (Figure 1), indicating that NGAL can be a very effective tool for early AKI detection in low-birth-weight neonatal populations. In contrast, KDIGO shows a lower positivity rate of 24.7%, with a 95% confidence interval between 16.4% and 35.4%. Although KDIGO can still detect AKI, its positivity is much lower compared to NGAL.
Overall, compared to KDIGO and nRIFLE, NGAL proved to be the most sensitive and responsive modality in detecting AKI in low-birth-weight neonates. These findings highlight the importance of selecting the right diagnostic tools for monitoring and managing AKI in this vulnerable neonatal population to ensure early detection and timely intervention.

4.2. The Correlation Between Changes in Serum Creatinine, Urine Volume, and NGAL

Based on Table 3 and Figure 2 depicting the correlation between changes in creatinine, urine volume, and NGAL from day one (D1) to day three (D3) in low-birth-weight neonates, the following conclusions can be drawn: Correlation of creatinine changes with NGAL changes: The Spearman (r) correlation value between creatinine and NGAL change is −0.026 with a p-value of 0.410, suggesting that there was almost no correlation between creatinine and NGAL changes. This indicates that the change in creatinine levels from D1 to D3 had no significant relationship with the change in NGAL levels in the neonates studied. Correlation of changes in urine volume with changes in NGAL: The Spearman correlation value (r) between the change in urine volume and NGAL was −0.167 with (p = 0.073). Although this negative correlation was stronger than that with creatinine, it was not statistically significant (p > 0.05), suggesting that there is a slight tendency for an increase in urine volume to be associated with a decrease in NGAL, but this is not strong enough to be considered significant. The results of this correlation analysis showed that changes in creatinine levels and urine volume from day one to day three were not significantly correlated with changes in NGAL levels in low-birth-weight neonates. In other words, changes in NGAL levels, as a marker of kidney injury, were not directly related to changes in creatinine or urine volume during this observation period.
As mentioned in Table 4, there was no statistically significant relationship found between subject characteristics (sex, gestational age, birth weight, delivery mode, and maternal hypertension history) and NGAL levels in low-birth-weight neonates (p > 0.05), suggesting that NGAL levels are not influenced by the above characteristics; in other words, subject characteristics (sex, gestational age, birth weight, delivery mode, and maternal hypertension history) were not confounding factors.
CKD potency could be detected earlier, i.e., from history-taking regarding neonatal low birth weight and prematurity [1,2,3,21]. Oligonephropathy-related prematurity is a predisposing factor for hypertension not only in adulthood but also during infancy. Delayed diagnosis and neglected hypertension are known to be contributing factors for CKD and end-stage kidney disease (ESKD) [22,23]. Primary prevention of CKD should be performed as soon as possible; that is, routine urinary and blood pressure screening should take place from childhood. Table 1 shows that the subjects in this study were homogeneous in terms of sex, gestational age, birth weight, and delivery methods.
As shown in Table 2, from the first 24 h, NGAL levels increased (above 150 ng/mL) in neonates experiencing oliguria, while creatinine levels did not. However, in neonates with AKI who improved after treatment, serum NGAL levels remained elevated, while serum creatinine levels did not increase, indicating that AKI detection in neonates can be performed early by determining urine production or examining NGAL levels. Serum creatinine cannot be used to determine AKI earlier in LBW neonates, perhaps because these neonates have very little muscle mass and lean body mass. In addition, this is also possibly because the neonates in this study received adequate management to improve AKI (proven by the urine volume, which was no longer oliguric). As a protein released by damaged tubular cells, NGAL continues to rise when urine volume starts to return to normal, indicating that although AKI has been improved, there are still many tubular cells that have not recovered from injury [24]. In the present study, an important finding is that NGAL can be detected earlier but is not very good for monitoring AKI as it improves; therefore, it is still necessary to monitor diuresis and creatinine levels as well as electrolyte and acid–base balance to monitor AKI which is being treated.
Table 3 shows that the positivity rate for first-day serum NGAL was better than that for serum creatinine, using both the KDIGO and nRIFLE criteria. This is in accordance with previous studies on adult and pediatric populations [13,14,15,19,20,24,25,26,27,28]. In a systematic review study, Xu et al. (2022) state that NGAL is very good at detecting AKI conditions that require kidney replacement therapy (KRT); however, this systematic review only includes studies on adult populations (more than 18 years old), and there are no studies on children, infants, and neonates [24]. Maisel et al. (2016)’s research states that an NGAL cut-off point of more than 150 ng/dL is a strong predictor that AKI is at risk of worsening kidney failure, and Andriani et al. (2015) find that this cut-off point has very high specificity and sensitivity, i.e., 88 and 81%, respectively [14,17]. Batte et al. (2022) state that high NGAL values in children with sickle cell disease are associated with high mortality [26], and according to Zhang et al., NGAL is significant as an early detector of AKI in the adult population [15]. However, the present study is the first to examine this in LBW neonates.
Table 5 shows that there was no correlation between changes in urine volume and changes in creatinine and NGAL, which is not in accordance with previous studies which showed that NGAL and creatinine were correlated with urine volume. The different results obtained in this study may be because NGAL at 24 h was increased in LBW neonates with AKI who then underwent adequate management so that AKI improved, as can be seen from the urine volume, which was no longer oliguric on the third day of examination. The good outcomes of this therapy resulted in no increase in creatinine, urine volume, or polyuria, while NGAL continued to increase. As NGAL is a tubular protein, this indicated that injury to the tubules had not yet healed completely. This strongly suggests that NGAL is useful for early AKI detection in LBW neonates but not for monitoring improvement in AKI; therefore, the combination of NGAL, urine volume, and serum creatinine level monitoring is important for successfully managing AKI in LBW neonates. It is known that NGAL was significantly elevated in neonatal sepsis, so neonates with early symptoms or signs of sepsis such as severe asphyxia, RDS, and hypotension were excluded from this study because this would cause bias or confusion regarding the increase in NGAL values which may be due to inflammatory process.
Zou (2023)’s meta-analysis included most of the pediatric population, finding that, interestingly, NGAL was very accurate in detecting AKI in asphyxiated neonates [13]. However, no research has specialized in preterm neonates at 28–34 weeks of gestational age. Although previous studies regarding NGAL in neonates have been published, controversy remains, especially according to Sarafidis et al. (2014) who stated that NGAL could not predict AKI 1–2 days earlier than creatinine, while other studies said it could [16]. For example, Hanna et al. (2016) and Elmas et al. (2017) stated that urine NGAL could detect AKI earlier in nonseptic and nonasphyxiated neonates [18,19]. The controversies between several of these studies necessitate a systematic review of NGAL’s role in early AKI detection in preterm neonates. Therefore, this research is essential because it adds to the repertoire of systematic reviews that the suspicion that AKI occurs more often in preterm and low-birth-weight (LBW) neonates. An LBW state is associated with hypothermia and metabolic disorders, which are often superimposed on metabolic disorders due to early-phase AKI.

4.3. The Study Novelty and Limitation

This study is the first in which changes in serum NGAL and creatinine levels in neonates with improved AKI are compared. However, this study has some limitations, i.e., its single-center setting and the number of subjects not being representative enough to determine the cut-off point for NGAL in neonates with AKI.

5. Conclusions

The results conclude that serum NGAL cannot represent improved AKI, demonstrated by a non-significant correlation between the two; hence, monitoring of creatinine and urinary production is still needed to manage LBW neonates with AKI.

Author Contributions

Conceptualization, T.Y., F.A.K., A.P. and A.W.; Methodology, T.Y., F.A.K. and A.P.; Software, F.A.K., A.P., D.O.E. and J.E.S.; Validation, T.Y. and A.P.; Formal analysis, A.P. and D.O.E.; Investigation, T.Y., A.P. and D.O.E.; Resources, T.Y., A.P., D.O.E. and A.W.; Data curation, A.P. and A.W.; Writing—original draft, D.O.E.; Writing—review & editing, T.Y., F.A.K., D.O.E. and J.E.S.; Visualization, D.O.E. and J.E.S.; Supervision, J.E.S.; Project administration, A.P.; Funding acquisition, A.P. All authors have read and agreed to the published version of the manuscript.

Funding

Internal research grant of Universitas Padjadjaran No. 1753/UN631/PT00/2024.

Institutional Review Board Statement

The study was conducted in accordance with the Declaration of Helsinki, and approved by the Institutional Review Board (or Ethics Committee) of Hasan Sadikin General Hospital, No.DP.04.03/D.XIV.6.5./112/2024, for studies involving humans.

Informed Consent Statement

Informed consent for study participation was gained from a parent and/or legal guardian.

Data Availability Statement

The original contributions presented in this study are included in the article. Further inquiries can be directed to the corresponding author.

Conflicts of Interest

The authors declare that they have no competing interests.

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Kidneydial 06 00014 g001
Figure 1. Bar chart of AKI positivity rate based on NGAL, KDIGO, and nRIFLE.
Figure 1. Bar chart of AKI positivity rate based on NGAL, KDIGO, and nRIFLE.
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Figure 2. Scatter plot of correlation between serum creatinine changes, urinary volume, and serum NGAL.
Figure 2. Scatter plot of correlation between serum creatinine changes, urinary volume, and serum NGAL.
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Table 1. Characteristics of low-birth-weight neonates.
Table 1. Characteristics of low-birth-weight neonates.
Variablesn = 77
Gender, n (%)
 Male45 (58.4)
 Female32 (41.6)
Gestational Age (weeks), Median (Min–Max)33 (28–34)
Birth Weight (gram), Median (Min–Max)1600 (750–2150)
Delivery Method, n (%)
 SC35 (45.5)
 Spontaneous42 (54.5)
APGAR 1, Median (Min–Max)7 (3–8)
APGAR 2, Median (Min–Max)8 (4–9)
APGAR 5, Median (Min–Max)9 (5–10)
Maternal Hypertension, n (%)21 (27.3)
SC, cesarean section; APGAR, appearance, pulse, grimace, activity, and respiration.
Table 2. Urinary volume, serum creatinine, and NGAL changes in LBW neonates between D1 and D3.
Table 2. Urinary volume, serum creatinine, and NGAL changes in LBW neonates between D1 and D3.
D1D3Changesp-Value
Urinary Volume (mL/kg/h)
Median (IQR)1.4 (1.2–1.5)3.0 (2.8–3.5)1.6 (1.4–2.0)<0.001 *
Min–Max0.0–4.10.8–4.5−2.1–2.9
Creatinine (mg/dL)
Median (IQR)0.76 (0.62–0.96)0.74 (0.63–0.98)0.01 (−0.2–0.28)0.655
Min–Max0.10–1.820.10–2.84−0.96–2.34
NGAL (ng/mL)
Median (IQR)168.04 (92.37–375.71)507.34 (254.73–961.76)201.76 (65.45–585.92)<0.001 *
Min–Max20.20–1612.0436.10–1844.87−817.06–1558.20
IQR = interquartile range, analysis using Wilcoxon signed-rank test, and * significance p < 0.05.
Table 3. Proportion of neonates classified as AKI based on NGAL, KDIGO, and nRIFLE.
Table 3. Proportion of neonates classified as AKI based on NGAL, KDIGO, and nRIFLE.
Diagnostic Modality
of AKI		Positivity Rate (%)95% CI
Positivity Rate		p-Value (Cochran’s Q Test)
NGAL81.871.8–88.8<0.001 *
KDIGO24.716.4–35.4
nRIFLE10.45.4–19.2
AKI = acute kidney injury, * significance p < 0.05. In this study “positivity rate” refers to the proportion of the total cohort classified as AKI by each modality.
Table 4. The association between the characteristics of the subjects and NGAL levels amongst low-birth-weight neonates.
Table 4. The association between the characteristics of the subjects and NGAL levels amongst low-birth-weight neonates.
VariableNGAL (ng/mL)p-Value
nMedian (Min–Max)
Gender
 Male45150.96 (20.20–1536.56)0.457
 Female32181.07 (49.06–1612.03)
Gestational age (weeks)
 28–3014114.34 (20.20–1114.07)0.196
 31–3463177.15 (30.91–1612.03)
Birth weight (grams)
 750–150020114.34 (20.20–1114.07)0.120
 >1500–215057177.15 (30.91–1612.03)
Delivery methods
 Cesarean section35132.11 (20.20–1612.03)0.493
 Spontaneous42181.07 (30.91–1536.56)
Maternal hypertension
 Yes21110.89 (20.20–566.32)0.146
 No56181.07 (30.91–1612.03)
Analysis using the Wilcoxon rank-sum test.
Table 5. The correlation between serum creatinine changes and urine volume and NGAL.
Table 5. The correlation between serum creatinine changes and urine volume and NGAL.
VariableSerum NGAL Changes
rp-Value
Serum creatinine changes−0.0260.410
Urinary volume changes−0.1670.073
Using Spearman’s rank correlation.
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Yuniati, T.; Kadi, F.A.; Primadi, A.; Erfanti, D.O.; Siswanto, J.E.; Widiasta, A. Neutrophil Gelatinase-Associated Lipocalin as a Useful Modality in Early Acute Kidney Injury Detection Amongst Low-Birth-Weight Neonates. Kidney Dial. 2026, 6, 14. https://doi.org/10.3390/kidneydial6010014

AMA Style

Yuniati T, Kadi FA, Primadi A, Erfanti DO, Siswanto JE, Widiasta A. Neutrophil Gelatinase-Associated Lipocalin as a Useful Modality in Early Acute Kidney Injury Detection Amongst Low-Birth-Weight Neonates. Kidney and Dialysis. 2026; 6(1):14. https://doi.org/10.3390/kidneydial6010014

Chicago/Turabian Style

Yuniati, Tetty, Fiva Aprilia Kadi, Aris Primadi, Dwi Oktari Erfanti, Johanes Edy Siswanto, and Ahmedz Widiasta. 2026. "Neutrophil Gelatinase-Associated Lipocalin as a Useful Modality in Early Acute Kidney Injury Detection Amongst Low-Birth-Weight Neonates" Kidney and Dialysis 6, no. 1: 14. https://doi.org/10.3390/kidneydial6010014

APA Style

Yuniati, T., Kadi, F. A., Primadi, A., Erfanti, D. O., Siswanto, J. E., & Widiasta, A. (2026). Neutrophil Gelatinase-Associated Lipocalin as a Useful Modality in Early Acute Kidney Injury Detection Amongst Low-Birth-Weight Neonates. Kidney and Dialysis, 6(1), 14. https://doi.org/10.3390/kidneydial6010014

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