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ObjectiveEarly-onset sepsis (EOS), which occurs within the first 72 hours of life, can often be fatal for neonates. Machine learning (ML) models demonstrate promise for timely diagnosis. However, current ML models primarily rely on data from high-income countries, which reduces their applicability to low-income and middle-income countries (LMICs) that have a higher burden and different disease profiles. We developed an ML model for the timely prediction of culture-proven EOS in LMICs.MethodsWe conducted a secondary analysis of the Delhi Neonatal Infection Study (2011–2014) carried out in three level-3 neonatal units in India. Data from inborn neonates suspected of having EOS were extracted, and cases of culture-negative sepsis were excluded. By implementing a dynamic 80:20 (train:test) data split, two feature selection methods were employed—Boruta and Lasso—across 64 variables, and five ML techniques were applied. The aim was to achieve 90% sensitivity to identify the optimal model based on performance metrics. The developed model was integrated into a web application and validated in an external cohort of neonates born between 2015 and 2021.ResultsOf 2924 neonates, 548 (18.7%) had culture-proven sepsis. The mean gestation and birth weight were 35.3 (±3.8) weeks and 2112 (±754) g, respectively. The Boruta and random forest classifier yielded the best model, which included 28 perinatal–neonatal variables. The sensitivity and specificity of the model were 90.3% and 40.6%, respectively. In external validation (n=147; 26 culture-proven sepsis cases), the model’s sensitivity, specificity, positive predictive value and negative predictive value were 92.3%, 37.2%, 24.0% and 95.7%, respectively. The sensitivity was 100% in asymptomatic neonates with only perinatal risk factors for EOS. The use of the model could have reduced antibiotic usage from 74.8% to 55.7% (risk difference: −19.1%; 95% CI −8.3 to −29.7).ConclusionsThe ML model demonstrated high sensitivity and acceptable specificity in predicting EOS. This prediction model has the potential to assist in the timely and reliable identification of culture-positive sepsis and may serve as a bedside decision support tool in LMICs.

Despite advancement in medical care, Rh alloimmunisation remains a major cause of neonatal hyperbilirubinaemia, neuro-morbidity, and late-onset anaemia. Delayed cord clamping (DCC), a standard care now-a-days, is yet not performed in Rh-alloimmunised infants due to paucity of evidence. Hence, we randomised these infants of 28- to 41-week gestation to delayed cord clamping (N = 36) or early cord clamping (N = 34) groups. The primary outcome variable was venous packed cell volume (PCV) at 2 h of birth. The secondary outcomes were incidence of double volume exchange transfusion (DVET) and partial exchange transfusion (PET), duration of phototherapy (PT), functional echocardiography (parameters measured: superior vena cava flow, M-mode fractional shortening, left ventricular output, myocardial perfusion index, and inferior vena cava collapsibility) during hospital stay, and blood transfusion (BT) until 14 weeks of life. Neonates were managed as per unit protocol. The baseline characteristics of enrolled infants were comparable between the groups. The median (IQR) gestation and mean (SD) birth weight of enrolled infants were 35 (33–37) weeks and 2440 (542) g, respectively. The DCC group had a higher mean PCV at 2 h of life (48.4 ± 9.2 vs. 43.5 ± 8.7, mean difference 4.9% (95% CI 0.6–9.1), p = 0.03). However, incidence of DVET and PET, duration of PT, echocardiography parameters, and BT until 14 weeks of postnatal age were similar between the groups.Conclusion: DCC in Rh-alloimmunised infants improved PCV at 2 h of age without significant adverse effects.Trial registration: Clinical Trial Registry of India (CTRI), Ref/2016/11/012572 http://ctri.nic.in/Clinicaltrials, date of trial registration 19.12.2016, date of first patient enrolment 1 January 2017.What is Known:•Delayed cord clamping improves haematocrit, results in better haemodynamic stability, and decreases the need of transfusion in early infancy.•However, due to lack of evidence, potential risk of hyperbilirubinaemia, and exacerbation of anaemia (following delayed cord clamping), early cord clamping is the usual norm in Rh-alloimmunised infantsinfants.What is New:•Delayed cord clamping in Rh-alloimmunised infants improves haematocrit at 2 h of life without any increase in incidence of serious adverse effects.

The aim of this prospective observational study was to compare the incidence of endotracheal tube (ETT) malposition using weight-based (Tochen), gestation-based (Kempley), and nasotragal length (NTL) methods in deceased neonates and fresh stillbirths. We enrolled deceased neonates and fresh stillbirths within 2 ± 1 h of death or delivery, respectively; without hydrops, tracheostomy or major congenital anomalies affecting face, neck, or thorax. Each enrolled subject was intubated orotracheally, with lip-to-tip distance determined by three methods in random succession. Chest X-ray was acquired after each insertion. The primary outcome was proportion of malpositioned ETTs on chest X-ray (defined as ETT tip not lying between upper border of T1 and lower border of T2 vertebrae), assessed by two experts masked to the methods used. The proportion of malpositioned tubes was not significantly different with any of the three methods: (weight 27/50 (54%), gestation 35/50 (70%), and NTL 35/50 (70%), p value 0.055). The malpositioned tubes were too far in (87/150; 58%) than too far out (10/150; 6.7%).Conclusions: None of the currently recommended methods accurately predicts optimal ETT length in neonates. There is an urgent need for newer bedside modalities for estimating ETT position in neonates.What is known?• NRP guidelines recommend gestation-based and nasotragal length (NTL) methods to estimate initial ETT depth in neonates. Weight-based (Tochen) method is still widely used in neonatal units for ETT depth estimation. Evidence till date has not proven superiority of one method over the other.What is new?• All three methods for ETT depth estimation (Tochen, gestation-based, and NTL) resulted in high rates of ETT malposition in neonates. Formulae, devised from this study based on linear regression models, did not perform well for estimation of optimal ETT position.

The guidelines for surfactant therapy are largely based on studies done in developed coun1tries wherein the facility infrastructure, patient profile, and clinical practices are different from low- and middle-income countries (LMICs). Though SRT is widely practiced in developing countries, there exists variability in clinical practice. Our objective was to identify the factors which would predict the need of surfactant administration and develop a “clinical respiratory distress (RD) score” for surfactant administration in preterm neonates with respiratory distress. A prospective observational study was conducted in 153 preterm infants (260/7 to 346/7 weeks gestation) with respiratory distress who were managed with CPAP and/or surfactant where indicated. Gestation < 32 weeks, no antenatal corticosteroid (ANS), hypothermia at admission, Apgar score < 3 at 1 minute, and Silverman score > 2 at 2 hours were found to be the significant factors in predicting surfactant requirement in multivariate regression analysis. A seven point scale was developed and categorized into two categories as < 4 and ≥ 4. The sensitivity, specificity, PPV, and NPV were 67%, 87%, 86%, and 68%, respectively, with a cutoff score ≥ 4. The positive likelihood ratio was 5.07 (95% CI 2.71–9.48), and negative likelihood ratio was 0.38 (95% CI 0.28–0.52). The observed rate of surfactant administration was found to be around 32% when the composite score was below four, and the rate increased to almost 86% when the composite score was ≥ 4. The predictive accuracy of the model was subsequently evaluated in a cohort of 56 preterm infants with respiratory distress.. Sensitivity, specificity and positive and negative predictive value during the validation phase were 97%, 73%, 85%, and 94%, respectively. With a composite score less than 4, the observed rate of surfactant administration was 6% (95% CI 1%–28%) as against the model predicted rate of 24%, while with composite score ≥ 4, the observed rate was 85% (95% CI 69%–94%) as against the model predicted rate of 90%.Conclusion: “Clinical RD score” is a simple score, which can be utilized for decision-making for early surfactant administration for preterm infants (260/7 to 346/7 weeks gestation) with respiratory distress.Trial Registration: NCT03273764What is Known:• Both CPAP and surfactant therapy are effective in management of preterm infants with RDS.• The efficacy of surfactant replacement therapy is better when it is administered early in the course of disease.What is New:• Many of the known risk factors for RDS do not predict surfactant requirement.• “Composite RD score” comprising of five independent predictors of surfactant requirement with a numeric cutoff may help decide which preterm neonates with respiratory distress need early surfactant administration in low- and middle-income countries.

ObjectiveTo evaluate mortality and short-term morbidities in extremely low birth weight (ELBW) infants (<1000 g) in a birth cohort in North India.MethodsIn-hospital data of 231 ELBW infants (Jan 2013 to Sept 2018) were collected from a prospectively maintained electronic database by using standard definitions.ResultsThe mean (SD) gestation and birth weight were 27.9 (2.2) weeks and 783 (133) g, respectively. Major morbidities included respiratory distress syndrome (n = 132, 57%), moderate-to-severe bronchopulmonary dysplasia (n = 62, 26.8%), hemodynamically significant patent ductus arteriosus (n = 65, 28%), intracranial hemorrhage ≥ grade II (n = 38, 16%), and culture-positive sepsis (n = 44, 19%). Median (IQR) duration of hospital stay (survivors) was 50 (17–79) days. The overall survival was 62%. On logistic regression, severe birth asphyxia, gestation ≤26 weeks, and respiratory distress syndrome were major predictors of mortality.ConclusionIn the current ELBW cohort, nearly two-thirds survived until discharge, who had considerable morbidities needing prolonged hospital stay. This study can be utilized for counseling and planning of care of ELBW infants in similar settings.

Purpose: With improving survival of preterm neonates, retinopathy of prematurity (ROP) is emerging as a major cause of childhood blindness. Incidence of sight-threatening ROP can be reduced by improving the quality of care provided to preterm neonates. Methods: This before-and-after study was designed to develop a need-based intervention package to improve knowledge, skills, and practices of those providing care for preterm neonates, and to evaluate the effectiveness of this package when combined with point-of-care quality improvement (POCQI) in improving survival of preterm neonates without sight-threatening ROP. The study had a formative component to assess baseline knowledge, skills, practices and attitudes, and to assess the needs of the healthcare staff to improve the care of preterm neonates. It was conducted in four special care neonatal units (SCNU) in the state of Madhya Pradesh in India. Results: A theory of change was developed to guide the development of study tools including needs assessment and educational package development. The educational package thus developed has been tested at the study sites in combination with POCQI projects driven by local teams of healthcare providers. The effectiveness of the interventions has been evaluated by collection of individual-level data on neonates admitted at the study sites. Conclusion: A multidimensional educational package integrated with system changes in the form of quality improvement (QI) endeavours driven by local context and needs were developed and evaluated in the project.

ObjectivesTo investigate if intravenous fentanyl or intravenous ketamine can provide adequate analgesia in preterm infants undergoing laser photocoagulation for retinopathy of prematurity (ROP).DesignOpen-label randomised trial.SettingTertiary care institution.ParticipantsPreterm infants who underwent laser photocoagulation for ROP.InterventionsInfants 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 measuresProportion 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.ResultsA 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.ConclusionsFentanyl-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 numberCTRI/2018/03/012878.

To compare the efficacy of low dose fentanyl infusion and 24% oral sucrose in providing optimal pain relief during laser for retinopathy of prematurity (ROP), we enrolled fifty-eight spontaneously breathing preterm infants undergoing laser. The preterm infants were randomized to either fentanyl infusion (1 mcg/kg/hr) or 24% oral sucrose (2 ml). We evaluated and compared the proportion of time spent crying during the procedure, salivary cortisol before and after the procedure, premature infant pain profile- revised (PIPP-R) scores during the procedure, apnoea during and after the procedure, need for mechanical ventilation, and feed intolerance and urinary retention 24 h after the procedure between the two groups. We found that the proportion of time spent crying during the procedure was significantly less in the fentanyl group [62.5% (50.7–74.2) vs 73.8% (55.6–83.4); P = 0.02]. Average PIPP-R score during the procedure was significantly less in the fentanyl group [7.2 vs 9.0; (mean difference of − 1.8; P = 0.01)]. There was no difference in other outcomes between the two groups.Conclusion: During laser for ROP, low dose fentanyl infusion was found to be efficacious in reducing pain as compared with 24% sucrose.What is Known:• Preterm infants undergoing laser photocoagulation for ROP suffer significant amount of pain.• Standard of care for pain relief in infants undergoing laser therapy in developed countries is general anesthesia (GA) or combination of sedation, analgesia, and paralysis (SAP).What is New:• During laser photocoagulation for ROP, fentanyl infusion at low dose (1 mcg/kg/hr) is efficacious in reducing pain as compared to 24% oral sucrose.