Need for Repeat-Hospitalization in Very Low Birth Weight or Very Preterm Infants: A Prospective Cohort Study.

OBJECTIVE: To determine the incidence of repeat-hospitalization amongst neonates with gestation <32 wk or birth weight <1500 g within 6 mo of birth. METHODS: All live births with gestation <32 wk or birth weight <1500 g born at a level-III NICU were prospectively enrolled and followed up through routine visits, multimedia and telephonically, fortnightly for re-hospitalization details till 6 mo of postnatal age. Main outcome measures were incidence, causes and risk factors for repeat-hospitalization. RESULTS: Of the 131 neonates enrolled, incidence and incidence density of repeat-hospitalization were 16% (95% CI 10.2-23.4) and 3.6 per 100 person-months, respectively. The most common causes for repeat-hospitalizations were pneumonia (n = 8; 29.6%), sepsis (n = 5, 18.5%), gastroenteritis (n = 3, 11.1%) and severe anemia (n = 2, 7.4%). Majority of repeat-hospitalizations (92.6%; 95% CI 74.1-98.5) occurred within 2 mo of discharge. The median hospital stay during repeat-hospitalizations was 4 d (IQR 1-21). On multivariate analysis, lower socioeconomic status was significantly associated with repeat-hospitalization (aOR 5.9, 1.3-23). Death after discharge occurred in 3 (2.3%) infants and were due to sudden infant death syndrome, complex cyanotic heart disease and pneumonia with multiple co-morbidities (one each). All deaths occurred at home. CONCLUSIONS: Nearly one-sixth of very low birth weight (VLBW) or very preterm infants required repeat-hospitalization after discharge, primarily within 2 mo of discharge. Infections, especially pneumonia, being the most common reason. A comprehensive follow-up package of post-discharge care for prevention of morbidities and timely hospital care for ongoing morbidities is required for optimal long-term survival of these infants.

Feeding Outcomes in Preterm Neonates with Antenatal Abnormal Umbilical Artery Doppler Profile: A Retrospective Cohort Study.

Neonates with absent-or-reversed umbilical artery end-diastolic flow (AREDF) are at an increased risk of feeding problems. In this retrospective study, authors evaluated the incidence of feed intolerance in 213 preterm neonates (January 2017-May 2022) with AREDF. The median (IQR) gestation and birth weight were 32 (30, 33) wk and 1120 (840, 1425) g, respectively. Of 213 neonates, 103 (48.4%; 95% CI 41.5%, 55.3%) neonates developed feed intolerance. Twelve of 213 neonates developed any stage necrotizing enterocolitis (NEC) (5.6%; 95% CI 2.9%, 9.6%) at a median age of 10 d. On multivariate regression, gestation was the only independent predictor of feed intolerance (OR 1.48; 95% CI 1.28, 1.70; for every 1 wk decrease below 36 wk). Almost 50% of preterm neonates with AREDF develop feed intolerance. Alternative feeding strategies warrant exploration to optimise nutrition in these neonates.

Antimicrobial resistance heterogeneity among multidrug-resistant Gram-negative pathogens: Phenotypic, genotypic, and proteomic analysis.

Microbes evolve rapidly by modifying their genomes through mutations or through the horizontal acquisition of mobile genetic elements (MGEs) linked with fitness traits such as antimicrobial resistance (AMR), virulence, and metabolic functions. We conducted a multicentric study in India and collected different clinical samples for decoding the genome sequences of bacterial pathogens associated with sepsis, urinary tract infections, and respiratory infections to understand the functional potency associated with AMR and its dynamics. Genomic analysis identified several acquired AMR genes (ARGs) that have a pathogen-specific signature. We observed that blaCTX-M-15, blaCMY-42, blaNDM-5, and aadA(2) were prevalent in Escherichia coli, and blaTEM-1B, blaOXA-232, blaNDM-1, rmtB, and rmtC were dominant in Klebsiella pneumoniae. In contrast, Pseudomonas aeruginosa and Acinetobacter baumannii harbored blaVEB, blaVIM-2, aph(3'), strA/B, blaOXA-23, aph(3') variants, and amrA, respectively. Regardless of the type of ARG, the MGEs linked with ARGs were also pathogen-specific. The sequence type of these pathogens was identified as high-risk international clones, with only a few lineages being predominant and region-specific. Whole-cell proteome analysis of extensively drug-resistant K. pneumoniae, A. baumannii, E. coli, and P. aeruginosa strains revealed differential abundances of resistance-associated proteins in the presence and absence of different classes of antibiotics. The pathogen-specific resistance signatures and differential abundance of AMR-associated proteins identified in this study should add value to AMR diagnostics and the choice of appropriate drug combinations for successful antimicrobial therapy.

Umbilical Cord Blood IgA Levels and Bacterial Profile in Preterm Neonates Born with Maternal Risk Factors for Early-Onset Neonatal Sepsis.

OBJECTIVES: To investigate the IgA levels and bacterial profile in umbilical cord blood (UCB) samples of mothers with risk factors compared to those without risk factors; and to understand the link between UCB culture positivity and neonatal outcomes [early-onset sepsis (EOS) or death within 7 d of life]. METHODS: This is a pilot prospective case-control study. Mothers with preterm deliveries (gestational age <34 wk) were enrolled in two groups- Cases: Those with antenatal risk factors (prolonged duration of rupture of membranes of ≥24 h or chorioamnionitis) and controls: Those without these two risk factors. Serum IgA levels was assayed and microbiological culture was tested in UCB samples. 16S sequencing to determine the UCB microbiome was performed in a subset of samples (n = 15). Neonates were followed-up for the occurrence of EOS or death until 7 d of life. RESULTS: Forty-nine mothers as cases and 50 mothers as controls were consecutively enrolled. No significant difference was observed in the IgA levels (60.5 vs. 58.1 mg/L; p = 0.71), neonatal blood culture positivity (4.1% vs. 8.0%; p = 0.41) and UCB culture positivity (30.6% vs. 26.0%; p = 0.61) in the two groups. No difference was observed between the groups in occurrence of EOS or death within 7 d of life. Proteobacteria, Firmicutes and Actinobacteria were the most abundant phyla. Serratia, Bifidobacterium, Collinsella, Meganomas and Blautia being the most common genera. CONCLUSIONS: Cord blood IgA concentration could not differentiate the neonates at-risk of infection due to its presence in both the groups.

Feasibility, Sustainability, and Effectiveness of the Implementation of "Facility-Team-Driven" Approach for Improving the Quality of Newborn Care in South India.

OBJECTIVES: The primary objective of the study was to assess the feasibility and sustainability of the implementation of the point of care quality improvement (POCQI) methodology for improving the quality of neonatal care at the level 2 special newborn care unit (SNCU). Additional objective was to evaluate the effectiveness of the quality improvement (QI) and preterm baby package training model. METHODS: This study was conducted in a level-II SNCU. The study period was divided into baseline; intervention and sustenance phases. The primary outcome i.e., feasibility was defined as completion of training for 80% or more health care professionals (HCPs) through workshops, their attendance in subsequent review meetings and, successful accomplishment of at least two plan-do-study-act (PDSA) cycles in each project. RESULTS: Of the total, 1217 neonates were enrolled during the 14 mo study period; 80 neonates in the baseline, 1019 in intervention and 118 in sustenance phases. Feasibility of training was achieved within a month of initiation of intervention phase; 22/24 (92%) nurses and 14/15 (93%) doctors attended the meetings. The outcomes of individual projects suggested an improvement in proportion of neonates being given exclusive breast milk on day 5 (22.8% to 78%); mean difference (95% CI) [55.2 (46.5 to 63.9)]. Neonates on any antibiotics declined, proportion of any enteral feeds on day one and duration of kangaroo mother care (KMC) increased. Proportion of neonates receiving intravenous fluids during phototherapy decreased. CONCLUSIONS: The present study demonstrates the feasibility, sustainability, and effectiveness of a facility-team-driven QI approach augmented with capacity building and post-training supportive supervision.

Probiotics for the prevention of mortality and sepsis in preterm very low birth weight neonates from low- and middle-income countries: a Bayesian network meta-analysis.

Background: Probiotics have been shown to reduce the risk of mortality and necrotizing enterocolitis (NEC) in very low birth weight (VLBW) neonates. The probiotic species with the maximal benefits in neonates from low- and middle-income countries are unknown. Objective: To identify the strain of probiotics with the maximum benefit in preventing neonatal mortality, sepsis, and NEC using the Bayesian network meta-analysis. Search methods: We searched Medline via PubMed, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL). We also hand-searched reference lists of previous systematic reviews to identify eligible studies. Selection criteria: Randomized controlled trials (RCTs) from LMICs comparing enteral supplementation of one or more probiotics with another probiotic species or placebo were included. Data collection and analysis: Two authors screened the studies, extracted the data, and examined the risk of bias using the Cochrane risk of bias 2 (RoB 2) tools. Bayesian network meta-analysis was performed using the "BUGSnet" package in R and RStudio (version 1.4.1103). The confidence in the findings was assessed using the Confidence in Network Meta-analysis (CINeMA) web application. Results: Twenty-nine RCTs enrolling 4,906 neonates and evaluating 24 probiotics were included. Only 11 (38%) studies had a low risk of bias. All the studies compared the probiotics with a placebo; none had a head-to-head comparison of different probiotic species. Also, only one study each had evaluated most probiotic regimens. When compared to placebo, the combination of B longum, B bifidum, B infantis, and L acidophilus may reduce the risk of mortality (relative risk [RR] 0.26; 95% credible interval [CrI] 0.07 to 0.72), sepsis (RR 0.47; 95% CrI 0.25 to 0.83), and NEC (RR 0.31; 95% CrI 0.10 to 0.78) but the evidence is very uncertain. There is low certainty evidence that the single probiotic species, B lactis, could reduce the risk of mortality (RR 0.21; 0.05 to 0.66) and NEC (RR 0.09; 0.01 to 0.32). Conclusion: Given the low to very low certainty of evidence for the efficacy of the two probiotics found to reduce mortality and necrotizing enterocolitis, no firm conclusions can be made on the optimal probiotics for use in preterm neonates in low- and middle-income countries. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42022353242, identifier: CRD42022353242.

Procalcitonin for Detecting Culture-Positive Sepsis in Neonates: A Prospective, Multicenter Study.

INTRODUCTION: It is unclear if serum procalcitonin (PCT) estimated at sepsis suspicion can help detect culture-positive sepsis in neonates. We evaluated the diagnostic performance of PCT in culture-positive sepsis in neonates. METHODS: This was a prospective study (February 2016 to September 2020) conducted in four level-3 units in India. We enrolled neonates suspected of sepsis in the first 28 days of life. Neonates with birth weight <750 g, asphyxia, shock, and major malformations were excluded. Blood for PCT assay was drawn along with the blood culture at the time of suspicion of sepsis and before antibiotic initiation. The investigators labeled the neonates as having culture-positive sepsis or "no sepsis" based on the culture reports and clinical course. PCT assay was performed by electrochemiluminescence immunoassay, and the clinicians were masked to the PCT levels while assigning the label of sepsis. Primary outcomes were the sensitivity, specificity, and likelihood ratios to identify culture-positive sepsis. RESULTS: The mean birth weight (SD) and median gestation (IQR) were 2,113 (727) g and 36 (32-38) weeks, respectively. Of the 1,204 neonates with eligible cultures, 155 (12.9%) had culture-positive sepsis. Most (79.4%) were culture-positive within 72 h of birth. The sensitivity, specificity, and positive and negative likelihood ratios at 2 ng/mL PCT threshold were 52.3% (95% confidence interval: 44.1-60.3), 64.5% (60.7-68.1), 1.47 (1.23-1.76), and 0.74 (0.62-0.88), respectively. Adding PCT to assessing neonates with 12.9% pretest probability of sepsis generated posttest probabilities of 18% and 10% for positive and negative test results, respectively. CONCLUSION: Serum PCT did not reliably identify culture-positive sepsis in neonates.

Comparison of regional versus global growth charts for the classification of small-for-gestational age neonates.

OBJECTIVE: To compare the performance of regional versus global charts for identifying small-for-gestational age (SGA) neonates with short-term adverse outcomes. DESIGN: Prospective cohort study. SETTING: Level-3 neonatal unit in India. PATIENTS: Neonates were categorised into SGA and appropriate-for-gestational age (AGA; 10th-90th centile) using four charts, namely, the AIIMS, Lubchenco, Fenton and Intergrowth 21st charts. They were followed up for adverse outcomes until 28 days. OUTCOMES: We evaluated the (1) burden of SGA, (2) sensitivity and diagnostic OR (DOR), (3) relative risk (RR) and number needed to screen (NNS) to detect adverse outcomes in SGA versus 'optimal' AGA (50th-90th centile) and (4) RR of morbidities in 'additional SGA' (ie, classified as SGA by others but not by AIIMS chart). RESULTS: Among 1367 neonates, 19.6%, 4.5% and 12.5% were classified as SGA by Intergrowth 21st, AIIMS and Lubchenco charts, respectively. Intergrowth 21st had the highest sensitivity (39.1%) but the least DOR (2.6) to detect adverse outcomes; AIIMS chart had low sensitivity (19.3%) but higher DOR (4.3). RR and NNS were 3.7 and 14; 4.4 and 7; 4.0 and 8; 3.6 and 10 with Intergrowth 21st, AIIMS, Lubchenco and Fenton charts, respectively. 'Additional SGA' identified by Intergrowth 21st had lower risk of adverse outcomes than SGA identified by both the charts (RR 0.39; 95% CI 0.19 to 0.82). CONCLUSIONS: Compared with AIIMS and Lubchenco charts, Intergrowth 21st runs the risk of overdiagnosing SGA neonates who may not be at a higher risk of short-term morbidities.

Gut microbiome dysbiosis in neonatal sepsis.

Sepsis is a highly heterogeneous, life-threatening organ dysfunction primarily caused by a dysregulated immune response to counter bacterial, viral, or fungal infections, resulting in haemodynamic changes and significant morbidity and mortality across all ages. In recent times, it has become one of the foremost causes of morbidity and mortality among newborns globally. The neonates, particularly the preterm neonates, due to their immature immune systems and non-canonical microbial community acquisition in the gastrointestinal tract and other body habitats, are adversely affected compared to the elderly with immunocompromised conditions. The neonates could acquire microbiota in utero or during delivery from the mother's genital tract or postnatally from contact with hospital personnel and the immediate hospital environment after the birth. Other factors that may enhance the risk include early colonization of microbiota by pathogens that trigger dysbiosis of the gut microbiome accompanied by a dysregulated immune response, organ dysfunction, and potential death. The sepsis-linked mortality could be prevented by timely diagnosis, selective antibiotic therapy, and supportive postnatal care. Infections due to antibiotic-resistant bacteria severely restrict possible therapeutic options, thus extending hospital stays. A comprehensive analysis of the infecting pathogens, cognate host responses, and the microbiota present would certainly help formulate appropriate interventions.

Short-term neurodevelopment and growth outcomes of very and moderate preterm Indian infants.

OBJECTIVE: To study the growth and neurodevelopmental outcome of very and moderate preterm infants (VMPT) compared to term appropriate-for-age (term AGA) infants at 18-months corrected age. METHODS: This prospective cohort study enrolled consecutively born 212 VMPT infants and 250 term AGA controls delivered during study period. OUTCOME MEASURES: Major neurodevelopmental impairment (NDI) defined as any one of cerebral palsy, motor (MoDQ) or mental developmental quotient (MoDQ) <70 on Developmental Assessment Scale for Indian infants, visual or hearing impairment, or epilepsy, and growth outcomes. RESULTS: Among 195 VMPT and 240 term AGA infants who completed follow-up, the frequency of major NDI was 12.8% and 2.5% respectively (RR 5.1; 95% CI [2.13-12.19]). Major NDI was higher among infants <28 weeks gestation (39%) and birthweight <1000 grams (27%). A quarter of VMPT infants exhibited wasting and 18% stunting than 7% each among controls. CONCLUSION: VMPT infants had a higher frequency of major NDI and growth failure at 18-months.

Simulation Based vs Conventional Training for Initial Steps in Delivery Room Care of Preterm Neonates: An Open Label Randomized Trial.

OBJECTIVE: To assess whether simulation based education (SBE) improves the practices and knowledge of junior residents for stabilization of a preterm neonate in delivery room as compared to conventional education (CE). METHODS: This trial randomized 24 pediatric residents to either SBE (n=12) or CE (n=12) groups. One-time SBE was imparted to the SBE group. Both the groups had similar facilitator participant ratio and equally timed sessions. The individual skills scores and performance by preterm stabilization performance evaluation (PSPE) score in real time were recorded using a validated tool within 8 weeks of the training. Knowledge gain was evaluated using pre and post-test scores. RESULTS: The mean (SD) skill and PSPE scores were comparable between the two groups (skill score 51.1 (8.1), 46.5 (7.8), respectively mean difference 4.6; 95% CI -2.1 to 11.3; PSPE-score 80.2 (14.2) vs. 82.9 (10.3); mean difference -2.68; 95% CI -8.35 to 13.71). The mean (SD) knowledge gain was similar in the groups [4.4 (1.9), 5.3 (4.1); mean difference 0.91; 95% CI, -1.81 to 3.64. CONCLUSION: In junior residents, a one-time SBE session, when compared to conventional task training, did not lead to improvement in the performance of the initial steps of neonatal resuscitation.

Secular Trends in Birthweights in Two Epochs Over 40 Years in a Tertiary Care Center.

OBJECTIVE: To compare the average birthweights and the weight centiles of the 'new' growth charts with the 'old' (1974) charts developed in the same unit four decades ago. METHODS: Birthweight and gestation data of the eligible 12,355 singleton neonates born between 2009 and 2016 at a level-3 neonatal unit at a public sector hospital were used to develop the new growth chart. We then compared the prevalence of small for gestational age (SGA) and large for gestational age (LGA) classified by the new charts and the old charts, the incidence of short-term adverse outcomes among them, and the diagnostic performance of both the charts to identify the adverse outcomes in a separate validation cohort. RESULTS: The mean birthweights of boys and girls across all gestations were higher by 150-200 g and 100-150 g, respectively, in the new chart. The prevalence of SGA doubled (9.8% vs 4.7%), but LGA decreased by one-third (17.5% vs 25.9%) with the new chart. However, the proportion of SGA and LGA having one or more short-term adverse outcomes, and the diagnostic performance of both the charts to identify neonates with short-term adverse outcomes, were comparable. CONCLUSION: There was an upward shift in the birthweights by about 150 g across all gestations in the new chart compared to the old chart developed 40 years ago. The findings imply the need to consider using updated growth charts to ensure accurate classification of size at birth of neonates.

'NOPAIN-ROP' trial: Intravenous fentanyl and intravenous ketamine for pain relief during laser photocoagulation for retinopathy of prematurity (ROP) in preterm infants: A randomised trial.

OBJECTIVES: To investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP). DESIGN: Open-label randomised trial. SETTING: Tertiary care institution. PARTICIPANTS: Preterm infants who underwent laser photocoagulation for ROP. INTERVENTIONS: Infants were randomised to receive fentanyl as intravenous bolus dose of 2 µg/kg, followed by an intravenous infusion of 1 µg/kg/hour increased to a maximum of 3 µg/kg/hour or intravenous ketamine as bolus dose of 0.5 mg/kg, followed by further intermittent intravenous bolus doses of 0.5 mg/kg to a maximum of 2 mg/kg in the initial phase and intravenous fentanyl (bolus of 2 µg/kg followed by infusion of 2 µg/kg/hour to a maximum of 5 µg/kg/hour) or intravenous ketamine (bolus dose of 1 mg/kg followed by intermittent bolus doses of 0.5 mg/kg to a maximum of 4 mg/kg) in the revised regimen phase. MAIN OUTCOME MEASURES: Proportion of infants with adequate analgesia defined as the presence of both: (1) all the Premature Infant Pain Profile-Revised scores measured every 15 min less than seven and (2) proportion of the procedure time the infant spent crying less than 5%.Secondary outcomes included apnoea, cardiorespiratory or haemodynamic instability, feed intolerance and urinary retention requiring catheterisation during and within 24 hours following the procedure. RESULTS: A total of 97 infants were randomised (fentanyl=51, ketamine=46). The proportions of infants with adequate analgesia were 16.3% (95% CI 8.5% to 29%) with fentanyl and 4.5% (95% CI 1.3% to 15.1%) with ketamine. Ten infants (19.6%) in the fentanyl group and seven infants (15.2%) in the ketamine group had one or more side effects. In view of inadequate analgesia with both the regimens, the study steering committee recommended using a higher dose of intravenous fentanyl and intravenous ketamine. Consequently, we enrolled 27 infants (fentanyl=13, ketamine=14). With revised regimens, the proportions of infants with adequate analgesia were higher: 23.1% (95% CI 8.2% to 50.2%) with fentanyl and 7.1% (95% CI 1.3% to 31.5%) with ketamine. However, higher proportions of infants developed apnoea (n=4; 30.7%), need for supplemental oxygen (n=5, 38.4%) and change in cardiorespiratory scores (n=7; 53.8%) with fentanyl but none with ketamine. CONCLUSIONS: Fentanyl-based and ketamine-based drug regimens provided adequate analgesia only in a minority of infants undergoing laser photocoagulation for ROP. More research is needed to find safe and effective regimens that can be employed in resource constrained settings. TRIAL REGISTRATION NUMBER: CTRI/2018/03/012878.

Preterm White Matter Injury: A Prospective Cohort Study.

OBJECTIVE: To determine the incidence and risk factors of preterm white matter injury [WMI; periventricular-intraventricular hemorrhage (PIVH) and/or periventricular leukomalacia (PVL)]. DESIGN: Prospective cohort study. SETTING: Level-3 neonatal intensive care unit. PATIENTS: Inborn preterm neonates (n=140) delivered at <32 weeks gestation or birthweight <1500 g. METHODS: Serial cranial ultrasounds were performed at postnatal ages of 3 days (±12 hour), 7 (±1) days, 21 (±3) days and 40 (±1) weeks postmenstrual age (PMA). PIVH and PVL were graded as per Volpe and De-Vries criteria, respectively. Univariate followed by multivariate analysis was done to evaluate risk factors for PIVH and PVL. OUTCOME MEASURES: The primary outcome was the incidence of preterm WMI. The secondary outcomes were evaluation of risk factors and natural course of WMI. RESULTS: The mean (range) gestation and birth weight of enrolled neonates were 29.7 (24-36) weeks and 1143 (440-1887) g, respectively. PIVH occurred in 25 (17.8%) neonates. PVL occurred in 34 (24.3%) neonates. None of them were grade III or IV PVL. Preterm WMI (any grade PIVH and/or PVL) occurred in 52 (37.1%) neonates. Severe PIVH (grade III) and cystic PVL occurred in 7 (5%) and 5 (3.6%) neonates, respectively. On multivariate analysis, none of the presumed risk factors were associated with PIVH. However, hemodynamically significant patent ductus arteriosus, and apnea of prematurity were significantly associated with increased risk of PVL. CONCLUSIONS: Significant WMI occurred only in one-third of the cohort, which is comparable to that described in literature from the developed countries.

Aqueous chlorhexidine 1% versus 2% for neonatal skin antisepsis: a randomised non-inferiority trial.

OBJECTIVE: To evaluate whether 1% aqueous chlorhexidine gluconate (CHG) when compared with 2% aqueous chlorhexidine gluconate is non-inferior for neonatal skin antisepsis. DESIGN: Parallel, blinded, non-inferiority randomised trial. SETTING: Level III, academic, neonatal intensive care unit. PATIENTS: Infants born at 260/7 to 426/7 weeks of gestation from June 2019 to December 2019. INTERVENTIONS: Participants were randomised to skin antisepsis by either 1% aqueous CHG or 2% aqueous CHG. MAIN OUTCOME MEASURES: The primary outcome was the proportion of negative skin swab cultures after skin antisepsis. Secondary outcomes were local skin reactions at 0, 6, 12 and 24 hours and plasma chlorhexidine levels in a subset of the study population. RESULTS: A total of 308 neonates with a median gestation age of 34 (31-37) weeks and mean birth weight of 2029 g were randomised on 685 occasions (1% CHG: n=341; 2% CHG: n=344). 93.0% of the post-antisepsis skin swabs were sterile in 1% CHG group compared with 95.6% of the swabs in the 2% CHG group (risk difference -2.7%, 95% CI -6.2% to +0.8%). The lower bound of 95% CI crossed the pre-specified absolute non-inferiority limit of 5%. Neonates developed mild dermatitis on 16 (2.3%) occasions. There was no significant difference in median plasma CHG levels in the two groups, 19.6 (12.5-36.4) and 12.6 (8.7-26.6) ng/mL, respectively. CONCLUSIONS: Application of 1% aqueous CHG was not shown to be non-inferior to 2% chlorhexidine aqueous for skin antisepsis in neonates. There were no severe skin-related adverse events in either of the two groups. TRIAL REGISTRATION NUMBER: CTRI/2019/06/019822; (http://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=33453&EncHid=&userName=CTRI/2019/06/019822).