Echocardiographic characteristics in neonates with septic shock.

Clinical parameters used for hemodynamic assessment and titration of vasopressor therapy in neonates with septic shock have several limitations. Functional echocardiography is an emerging tool for bedside assessment of cardiac function and may be useful for diagnosis of shock and assessing the response to therapy. Data regarding echocardiographic parameters in neonates with shock is lacking. This prospective observational study was conducted in a Level III NICU with the primary objective of comparing echocardiographic characteristics of neonates with septic shock at diagnosis, following fluid boluses, and after maximum inotropic support [A1]. Additionally, we compared these characteristics with those of healthy stable neonates who were gestation and postnatal age-matched. A total of 36 neonates with septic shock and 30 gestation and postnatal age-matched controls were enrolled. The mean (SD) gestation and birth weight of neonates with septic shock were 30.6 (4.0) weeks and 1538 (728) g, respectively. Gram-negative bacilli constituted 78.9% of all isolates. At presentation, there was no significant difference between neonates with shock and controls in terms of ventricular outputs, shortening fraction, ratio of early to late diastolic trans-mitral flow velocity, and myocardial performance indices. The distensibility index of inferior vena cava was higher in neonates with shock compared to controls, (17% vs 10%, (p < 0.01)). Left ventricular output was 209 (92) and 227 (102) ml/kg/min (p = 0.53) and right ventricular output was 427 (203) and 459 (227) ml/kg/min, (p = 0.03), respectively, before and after inotropic therapy.     Conclusion: Echocardiographic parameters may not differentiate neonates with septic shock from hemodynamically stable neonates. Neonates with shock associated with predominantly gram-negative sepsis are not able to augment cardiac functions, either at the onset or after administration of inotropes.      Trial registration: (CTRI/2017/12/010766). What is known: • For neonates with shock, echocardiography is becoming increasingly popular as an objective method of evaluating hemodynamics. • In healthy preterm neonate, cardiac output has been known to increase in response to altered hemodynamics during states of increased oxygen demand. What is new: •  In the setting of septic shock induced by gram-negative organisms, echocardiographic parameters are less likely to assist in the assessment of the response to vasoactive agents. Cytokines, induced by gram-negative organisms, may alter adrenoreceptors in myocardium and vasculature.

Unbound Bilirubin and Acute Bilirubin Encephalopathy in Infants Born Late Preterm and Term with Significant Hyperbilirubinemia.

OBJECTIVE: To compare the association of unbound bilirubin (UB), total serum bilirubin (TSB), and bilirubin:albumin molar ratio (BAMR) with acute bilirubin encephalopathy (ABE), as assessed by bilirubin-induced neurologic dysfunction (BIND) score, in infants with significant hyperbilirubinemia (TSB ≥20 mg/dL or underwent exchange transfusion). STUDY DESIGN: In this prospective cohort study, infants ≥34 weeks of gestational age with significant hyperbilirubinemia during the first 2 postnatal weeks were eligible, unless they had craniofacial malformations, chromosomal disorders, TORCH (toxoplasmosis, other infections, rubella, cytomegalovirus and herpes simplex) infections, surgery, or a family history of congenital deafness. TSB, serum albumin, and UB were measured at hospital admission using the colorimetric, bromocresol green, and modified peroxidase method, respectively. Infants were evaluated on admission for ABE using a standardized neurologic examination and assigned a BIND score by trained physicians. Infants with a total BIND score of 0 were deemed to not have ABE, whereas those with a score ≥1 were deemed to have ABE. RESULTS: A total of 151 infants were studied, among whom 37 (24.5%) had ABE. Of these, 19 had mild ABE (BIND score 1-3) and 18 had moderate-to-severe ABE (BIND score 4-9). On logistic regression, UB, but not TSB or BAMR, was associated with ABE (aOR 1.64; 95% CI 1.17-2.3). On ordered logistic regression, UB, but not TSB or BAMR, was associated with severity of ABE (aOR 1.76; 95% CI 1.28-2.4). CONCLUSIONS: Our findings of the association between UB and ABE indicate that BIND scoring may be useful for evaluation of ABE in infants ≥34 weeks of gestational age.

Effects of latent iron deficiency on auditory neural maturation during early infancy in infants above 35 weeks' gestation.

BACKGROUND: Latent iron deficiency (LID) at birth is associated with prolonged latencies in auditory brainstem response (ABR), a surrogate for neural maturation. This study aimed to compare wave and inter-peak latencies of ABR at birth and at 4-6 months of age in infants ≥35 weeks of gestation with normal iron status (NIS) and LID. METHODS: Neonates born at ≥35 weeks were screened. Cord ferritin value ≤ 75 ng/mL and >75 ng/mL were classified as LID and NIS, respectively. ABR was performed within 48 h of birth. The absolute latencies of waves I, III, and V, and inter-peak latencies I-III, III-V, and I-V were computed. Infants were reassessed at 4-6 months of age for hemoglobin, serum ferritin levels, and ABR latencies. RESULTS: In total, 160 neonates were enrolled. The mean (SD) birth weight and gestational age of the study population were 2843 (384) g and 38.3 (1.1) weeks, respectively. Approximately 122 infants completed follow-up until 4-6 months of age: 37 in the LID group and 85 in the NIS group. Overall, the wave and interpeak latencies in both groups at birth were comparable. At 4-6 months, the absolute latencies of waves I, III, and V, and inter-peak latencies I-III, III-V, and I-V were decreased and were comparable in both groups. Among small-for-gestational-age neonates, inter-peak latencies in I-III and I-V at birth were significantly longer in the LID group than in the NIS group. Nine (24.3%) infants in the LID group and none in the NIS group were iron-deficient at 4-6 months of age. CONCLUSION: There was no difference in wave or inter-peak latencies at birth and at 4-6 months of age in neonates aged ≥35 weeks with or without LID. However, infants with LID at birth have a significant risk of iron deficiency at 4-6 months of age. CTRI/2017/08/009379 (www.ctri.nic.in).

Amplitude integrated EEG: how much it helps in prognostication in neonatal encephalopathy?

INTRODUCTION: Neonatal encephalopathy (NE) is associated with a high risk of adverse neurological outcomes. Several neurodiagnostic tests have been evaluated to predict the prognosis. Amplitude integrated Electroencephalogram (aEEG) is now being commonly used for bedside evaluation of cerebral function. There is limited data on the role of aEEG for prognostication in NE, from resource-limited settings. OBJECTIVE: To evaluate the predictive ability of aEEG for abnormal neurological outcomes in neonatal encephalopathy or neonates with encephalopathy. METHODS: Neonates above 35 weeks of gestation admitted to NICU in a tertiary care hospital with a diagnosis of encephalopathy were enrolled. Clinical characteristics severity of encephalopathy and seizures were recorded. Amplitude integrated recording was started at admission and continued till recovery of trace to normal or for 10 days. The primary outcome was death or abnormal neurological status at 3-6 months of age. The study was registered in the Clinical Trial Registry of India (CTRI/2013/05/003612). RESULTS: The incidence of NE was 6% of total admission. Moderate and severe encephalopathy occurred in 58 and 39% of babies respectively. Hypoxic-ischemic encephalopathy was the most common cause. Clinical seizures occurred in 91% of cases. An abnormal aEEG trace was observed in 51 (76.1%) infants with NE. For adverse neurological outcomes at an age average of 4.5 months of age, aEEG had a sensitivity, specificity, NPV, and PPV of 100, 54.2, 100, and 77.5, respectively. CONCLUSIONS: Clinical staging and aEEG has good predictive ability to detect an adverse neurological outcome. aEEG improves the ability to predict abnormal outcome in babies with moderate encephalopathy. Early recovery of aEEG abnormality correlates with better neurodevelopmental outcomes.KEY MESSAGESWhat's known: aEEG is a useful modality to assess neurodevelopmental outcomes however data from developing countries is lacking.What's new: aEEG monitoring in babies in neonatal encephalopathy may improve the prediction of abnormal neurological outcomes in babies with moderate encephalopathy.

Development and validation of high definition phenotype-based mortality prediction in critical care units.

OBJECTIVES: The objectives of this study are to construct the high definition phenotype (HDP), a novel time-series data structure composed of both primary and derived parameters, using heterogeneous clinical sources and to determine whether different predictive models can utilize the HDP in the neonatal intensive care unit (NICU) to improve neonatal mortality prediction in clinical settings. MATERIALS AND METHODS: A total of 49 primary data parameters were collected from July 2018 to May 2020 from eight level-III NICUs. From a total of 1546 patients, 757 patients were found to contain sufficient fixed, intermittent, and continuous data to create HDPs. Two different predictive models utilizing the HDP, one a logistic regression model (LRM) and the other a deep learning long-short-term memory (LSTM) model, were constructed to predict neonatal mortality at multiple time points during the patient hospitalization. The results were compared with previous illness severity scores, including SNAPPE, SNAPPE-II, CRIB, and CRIB-II. RESULTS: A HDP matrix, including 12 221 536 minutes of patient stay in NICU, was constructed. The LRM model and the LSTM model performed better than existing neonatal illness severity scores in predicting mortality using the area under the receiver operating characteristic curve (AUC) metric. An ablation study showed that utilizing continuous parameters alone results in an AUC score of >80% for both LRM and LSTM, but combining fixed, intermittent, and continuous parameters in the HDP results in scores >85%. The probability of mortality predictive score has recall and precision of 0.88 and 0.77 for the LRM and 0.97 and 0.85 for the LSTM. CONCLUSIONS AND RELEVANCE: The HDP data structure supports multiple analytic techniques, including the statistical LRM approach and the machine learning LSTM approach used in this study. LRM and LSTM predictive models of neonatal mortality utilizing the HDP performed better than existing neonatal illness severity scores. Further research is necessary to create HDP-based clinical decision tools to detect the early onset of neonatal morbidities.

Restrictive Threshold for the Management of Patent Ductus Arteriosus in Very Low Birth Weight Neonates.

OBJECTIVE: To compare outcomes of very low birth weight (VLBW) neonates before and after the change in practice for treatment of PDA. METHODS: Medical records of VLBW neonates were reviewed. Neonates were categorized in two groups: Period I (January, 2012 to July, 2015) and Period II (August, 2015 to December, 2016). The primary outcome of study was composite outcome of death or broncho-pulmonary dysplasia (BPD). RESULTS: The composite outcome (Death/BPD) was comparable in two groups; adjusted OR (95% CI) 1.1 (0.6, 1.9). Mortality and severe BPD were also comparable. The pharmacological treatment for PDA was required in 8.4% vs 2.6% of VLBW neonates during Period I and II, respectively (P=0.03). Durations of invasive and noninvasive ventilation were comparable during two periods. CONCLUSIONS: Restrictive threshold for management of PDA in VLBW neonates may not be associated with increase in morbidities or mortality and possibly would reduce need for pharmacological treatment or surgical ligation.

Designing a bed-side system for predicting length of stay in a neonatal intensive care unit.

Increased length of stay (LOS) in intensive care units is directly associated with the financial burden, anxiety, and increased mortality risks. In the current study, we have incorporated the association of day-to-day nutrition and medication data of the patient during its stay in hospital with its predicted LOS. To demonstrate the same, we developed a model to predict the LOS using risk factors (a) perinatal and antenatal details, (b) deviation of nutrition and medication dosage from guidelines, and (c) clinical diagnoses encountered during NICU stay. Data of 836 patient records (12 months) from two NICU sites were used and validated on 211 patient records (4 months). A bedside user interface integrated with EMR has been designed to display the model performance results on the validation dataset. The study shows that each gestation age group of patients has unique and independent risk factors associated with the LOS. The gestation is a significant risk factor for neonates < 34 weeks, nutrition deviation for < 32 weeks, and clinical diagnosis (sepsis) for ≥ 32 weeks. Patients on medications had considerable extra LOS for ≥ 32 weeks' gestation. The presented LOS model is tailored for each patient, and deviations from the recommended nutrition and medication guidelines were significantly associated with the predicted LOS.

Machine Learning-Based Automatic Classification of Video Recorded Neonatal Manipulations and Associated Physiological Parameters: A Feasibility Study.

Our objective in this study was to determine if machine learning (ML) can automatically recognize neonatal manipulations, along with associated changes in physiological parameters. A retrospective observational study was carried out in two Neonatal Intensive Care Units (NICUs) between December 2019 to April 2020. Both the video and physiological data (heart rate (HR) and oxygen saturation (SpO2)) were captured during NICU hospitalization. The proposed classification of neonatal manipulations was achieved by a deep learning system consisting of an Inception-v3 convolutional neural network (CNN), followed by transfer learning layers of Long Short-Term Memory (LSTM). Physiological signals prior to manipulations (baseline) were compared to during and after manipulations. The validation of the system was done using the leave-one-out strategy with input of 8 s of video exhibiting manipulation activity. Ten neonates were video recorded during an average length of stay of 24.5 days. Each neonate had an average of 528 manipulations during their NICU hospitalization, with the average duration of performing these manipulations varying from 28.9 s for patting, 45.5 s for a diaper change, and 108.9 s for tube feeding. The accuracy of the system was 95% for training and 85% for the validation dataset. In neonates <32 weeks' gestation, diaper changes were associated with significant changes in HR and SpO2, and, for neonates ≥32 weeks' gestation, patting and tube feeding were associated with significant changes in HR. The presented system can classify and document the manipulations with high accuracy. Moreover, the study suggests that manipulations impact physiological parameters.

Development of data dictionary for neonatal intensive care unit: advancement towards a better critical care unit.

BACKGROUND: Critical care units (CCUs) with extensive use of various monitoring devices generate massive data. To utilize the valuable information of these devices; data are collected and stored using systems like clinical information system and laboratory information management system. These systems are proprietary, allow limited access to their database and, have the vendor-specific clinical implementation. In this study, we focus on developing an open-source web-based meta-data repository for CCU representing stay of the patient with relevant details. METHODS: After developing the web-based open-source repository named data dictionary (DD), we analyzed prospective data from 2 sites for 4 months for data quality dimensions (completeness, timeliness, validity, accuracy, and consistency), morbidity, and clinical outcomes. We used a regression model to highlight the significance of practice variations linked with various quality indicators. RESULTS: DD with 1555 fields (89.6% categorical and 11.4% text fields) is presented to cover the clinical workflow of a CCU. The overall quality of 1795 patient days data with respect to standard quality dimensions is 87%. The data exhibit 88% completeness, 97% accuracy, 91% timeliness, and 94% validity in terms of representing CCU processes. The data scores only 67% in terms of consistency. Furthermore, quality indicators and practice variations are strongly correlated (P < 0.05). CONCLUSION: This study documents DD for standardized data collection in CCU. DD provides robust data and insights for audit purposes and pathways for CCU to target practice improvements leading to specific quality improvements.

Chronic Auditory Toxicity in Late Preterm and Term Infants With Significant Hyperbilirubinemia.

BACKGROUND AND OBJECTIVES: Significant hyperbilirubinemia (SHB) may cause chronic auditory toxicity (auditory neuropathy spectrum disorder and/or sensorineural hearing loss); however, total serum bilirubin (TSB) does not discriminate neonates at risk for auditory toxicity. Our objective was to compare TSB, bilirubin albumin molar ratio (BAMR), and unbound bilirubin (UB) for their association with chronic auditory toxicity in neonates with SHB (TSB ≥20 mg/dL or TSB that met criteria for exchange transfusion). METHODS: Infants ≥34 weeks' gestational age (GA) with SHB during the first 2 postnatal weeks were eligible for a prospective longitudinal study in India. Comprehensive auditory evaluations were performed at 2 to 3 months of age by using auditory brainstem response, tympanometry, and an otoacoustic emission test and at 9 to 12 months of age by using audiometry. The evaluations were performed by an audiologist unaware of the degree of jaundice. RESULTS: A total of 93 out of 100 infants (mean GA of 37.4 weeks; 55 boys, 38 girls) who were enrolled with SHB were evaluated for auditory toxicity. Of those, 12 infants (13%) had auditory toxicity. On regression analysis controlling for covariates, peak UB (but not peak TSB or peak BAMR), was associated with auditory toxicity (odds ratio 2.41; 95% confidence interval: 1.43-4.07; P = .001). There was significant difference in the area under the receiver operating characteristic curves between UB (0.866), TSB (0.775), and BAMR (0.724) for auditory toxicity (P = .03) after controlling for covariates. CONCLUSIONS: Unconjugated hyperbilirubinemia indexed by UB (but not TSB or BAMR) is associated with chronic auditory toxicity in infants ≥34 weeks' GA with SHB.

Auditory toxicity in late preterm and term neonates with severe jaundice.

AIM: Jaundice may cause auditory toxicity (auditory neuropathy and hearing loss). However, total serum bilirubin (TSB) does not discriminate neonates at risk for auditory toxicity. We compared TSB, bilirubin:albumin molar ratio (BAMR), and unbound bilirubin for their association with auditory toxicity in neonates with severe jaundice (TSB ≥342µmol/L, or that met exchange transfusion). METHOD: Neonates greater or equal to 34 weeks gestational age with severe jaundice during the first 2 postnatal weeks were eligible for prospective cohort study, unless they had craniofacial malformations, chromosomal disorders, toxoplasmosis, other infections, rubella, cytomegalovirus, herpes simplex infections, surgery, or family history of congenital deafness. RESULTS: Twenty-eight out of 100 neonates (mean gestational age 37.4wks; 59 males, 41 females) had auditory toxicity. Peak unbound bilirubin, but not peak TSB and BAMR, was associated with auditory toxicity (p<0.05) in neonates with severe (TSB <427.5µmol/L) and extreme hyperbilirubinemia (TSB ≥427.5µmol/L). Area under the receiver operating characteristic curve for unbound bilirubin (0.78) was significantly greater (p=0.03) than TSB (0.54) among neonates with severe but not extreme hyperbilirubinemia. INTERPRETATION: Unbound bilirubin is more strongly associated with auditory toxicity than TSB and/or BAMR in greater or equal to 34 weeks gestational age neonates with severe jaundice. Unbound bilirubin is a better predictor than TSB in neonates with severe hyperbilirubinemia.

Biomolecular inflammatory response to surgical energy usage in laparoscopic surgery: results of a randomized study.

OBJECTIVE: Use of surgical energy is integral to laparoscopic surgery (LS). Energized dissection (ED) has a potential to impact the biomolecular expression of inflammation due to ED-induced collateral inflammation. We did this triple-blind randomized controlled (RCT) study to assess this biomolecular footprint in an index LS, i.e., laparoscopic cholecystectomy (LC). METHODS AND PROCEDURES: This RCT was conducted in collaboration with tertiary-level institutions, from January 2014 to December 2014 with institutional review board clearance. Consecutive, unselected, consenting candidates for LC were randomized (after anesthesia induction) into group I (ED) and group II (non-ED). They were managed with compliance to universal protocols for ethics, informed consent, anesthesia, drug usage and clinical pathway with blinded observers. Biomolecular inflammatory markers, i.e., interleukin 6 (IL-6), tumor necrosis factor-alpha (TNF-α) and highly sensitive CRP (HS-CRP), were measured with blood drawn juxta-preoperatively (H0), at 4 h (H4) and at 24 h (H24). The quantitative changes induced by ED on IL-6, TNF-α and HS-CRP at H0, H4 and H24 with their kinetic behavior were the study endpoint. Prospective data were analyzed statistically with a p value of <0.05 being significant. RESULTS: Two cases from the ED group had biliary injury and hence were withdrawn from analysis. The ED (n = 49) and non-ED (n = 51) groups had similar demographic, clinical and H0 biomolecular variables. There was a significant increase in IL-6, TNF-α and HS-CRP from H0 to H4 in both the groups (p values <0.001). From H4 to H24, all three cytokines showed significant increase in ED group (p < 0.05), whereas in the non-ED group, IL-6 showed significant fall (p = 0.004) and TNF-α showed no significant change (p = 0.063). Both the groups showed H4-H24 elevation of HS-CRP (p = 0.000). CONCLUSION: Energized dissection adds to the cytokine-mediated postoperative inflammation. The additional ED-induced inflammation can be measured objectively by IL-6 and TNF-α levels. CLINICAL TRIALS REGISTRY: Clinical Trials Registry, India (REF/2014/06/007153).

Latent iron deficiency at birth influences auditory neural maturation in late preterm and term infants.

BACKGROUND: In utero latent iron deficiency has been associated with abnormal neurodevelopmental outcomes during childhood. Its concomitant effect on auditory neural maturation has not been well studied in late preterm and term infants. OBJECTIVE: The objective was to determine whether in utero iron status is associated with auditory neural maturation in late preterm and term infants. DESIGN: This prospective cohort study was performed at Sir Ganga Ram Hospital, New Delhi, India. Infants with a gestational age ≥34 wk were eligible unless they met the exclusion criteria: craniofacial anomalies, chromosomal disorders, hemolytic disease, multiple gestation, third-trimester maternal infection, chorioamnionitis, toxoplasmosis, other infections, rubella, cytomegalovirus infection, and herpes simplex virus infections (TORCH), Apgar score <5 at 5 min, sepsis, cord blood not collected, or auditory evaluation unable to be performed. Sixty consecutive infants with risk factors for iron deficiency, such as small for gestational age and maternal diabetes, and 30 without risk factors for iron deficiency were enrolled. Absolute wave latencies and interpeak latencies, evaluated by auditory brainstem response within 48 h after birth, were measured and compared between infants with latent iron deficiency (serum ferritin ≤75 ng/mL) and infants with normal iron status (serum ferritin >75 ng/mL) at birth. RESULTS: Twenty-three infants had latent iron deficiency. Infants with latent iron deficiency had significantly prolonged wave V latencies (7.10 ± 0.68 compared with 6.60 ± 0.66), III-V interpeak latencies (2.37 ± 0.64 compared with 2.07 ± 0.33), and I-V interpeak latencies (5.10 ± 0.57 compared with 4.72 ± 0.56) compared with infants with normal iron status (P < 0.05). This difference remained significant on regression analyses after control for confounders. No difference was noted between latencies I and III and interpeak latencies I-III. CONCLUSION: Latent iron deficiency is associated with abnormal auditory neural maturation in infants at ≥34 wk gestational age. This trial was registered at clinicaltrials.gov as NCT02503397.

Human Milk Fortification in India.

Human milk fortification in preterm babies has become a standard of care in developed countries. Use of human milk fortifier (HMF) in very-low-birthweight infants is not a routine practice in India. There are concerns about high osmolality, feed intolerance, necrotizing enterocolitis, risk of contamination and added cost associated with use of HMF. There are limited data from India which address the issue of safety and short-term benefits of human milk fortification. This chapter highlights the issues related to human milk fortification in our country.

T-piece or self inflating bag for positive pressure ventilation during delivery room resuscitation: an RCT.

OBJECTIVE: To compare the duration of positive pressure ventilation (PPV) during delivery room resuscitation in neonates resuscitated with self-inflating bag (SIB) and T-piece resuscitator (TPR). DESIGN: Randomized control trial. SETTING: Delivery room and neonatal intensive care unit of a tertiary care center in northern India. PATIENTS: Consecutively born neonates more than 26 weeks of gestation requiring PPV at birth. INTERVENTION: Eligible neonates were randomized to two groups, SIB and TPR. OUTCOME MEASURES: Duration of PPV, intubation rates in delivery room, incidence of respiratory distress, need for mechanical ventilation during first 48h and its duration, need for surfactant replacement therapy and mortality during NICU stay. RESULTS: Fifty neonates received PPV with a SIB and 40 received PPV with a TPR. The mean (SD) birth weight and gestational age of neonates in SIB and TPR groups were 2264 (872) and 2065 (814)g; 35.1 (3.6) and 34.3 (3.7) weeks, respectively. The median (IQR) duration of PPV in delivery room was significantly less in TPR group as compared to SIB; 30 (30-60)s vs. 60 (30-90)s, respectively; (p<0.001). A higher proportion of neonates required delivery room intubation in SIB group as compared to TPR group (34% vs. 15%, p=0.04). In the TPR group, a higher proportion of neonates could be resuscitated with room air only (72.5% vs. 38%, p=0.001). Other outcomes were comparable in the two groups. Similar findings were observed in neonates <34 weeks, except that fewer neonates resuscitated with TPR required invasive ventilation (31.6% vs. 77.8%, p=0.008). CONCLUSION: Use of TPR during delivery room resuscitation resulted in shorter duration of PPV and lesser rates of intubation as compared to SIB. More infants in this group could be resuscitated with room air only (CTRI/2010/091/002946).

Abdominal circumference or gastric residual volume as measure of feed intolerance in VLBW infants.

BACKGROUND: The aim of the study was to compare prefeed abdominal circumference (AC) and gastric residual volume (GRV) as a measure of feed intolerance in very-low-birth-weight infants (VLBW). METHODS: Eighty VLBW infants were randomized to 2 groups; feed intolerance was monitored by measuring either GRV group or prefeed AC group. The primary outcome was time to full enteral feeds (180 mL · kg · day). Other main outcome measures were feed interruption days, duration of parenteral nutrition, incidence of culture positive sepsis, necrotizing enterocolitis, mortality, and duration of hospital stay. RESULTS: The median (interquartile range) time to achieve full feeds was 10 (9-13) versus 14 (12-17.5) days in AC and GRV groups, respectively (P < 0.001). Infants in AC group had fewer feed interruption days (0 [0-2] vs 2.0 [1, 5], P < 0.001) and shorter duration of parenteral nutrition (P < 0.001). The incidence of culture-positive sepsis in AC and GRV groups was 17.5% and 30 %, respectively (P = 0.18). Duration of hospital stay and mortality were comparable in both the groups. CONCLUSIONS: Prefeed AC as a measure of feed intolerance in VLBW infants may shorten the time taken to achieve full feeds.

Outcomes of laparoscopic cholecystectomy done with surgical energy versus done without surgical energy: a prospective-randomized control study.

OBJECTIVE: Laparoscopic cholecystectomy (LC), a gold standard procedure can be done without energized dissection (ED). We did a randomized study for the outcomes of LC done with ED or without ED, i.e., with cold dissection (CD). METHODS AND PROCEDURES: At a tertiary level institution, open-ended prospective-randomized control study was conducted between September 2008 and June 2013. Consecutive, unselected, consenting candidates for LC were enrolled following standard ethics, informed consent, anesthesia, and clinical pathway protocol. They were allocated to control group (LC with ED) or study group (LC with CD, as per our published technique with the option for rescue ED). The study points were based upon Clavien-Dindo grading of postoperative complications. They were either, peri-operative events potentially affecting, hospital stay (Grade I) or Grade II-V, e.g., peri-operative hemodynamic instability, needing intervention/blood transfusion, injury to biliary ducts/hollow viscous, postoperative biliary leak, postoperative re-intervention, re-hospitalization, mortality, and any adverse event during a 90-day follow-up period. The data were prospectively collected in an integrated "hospital information system" that could be retrieved only by independent external coordinators. RESULTS: Demographics, co-morbidities, and gallbladder inflammation profile of the control group (n = 361) and study group (n = 384) were comparable. There was no rescue ED usage in the study group. Hospital stay (Grade I adverse outcome dependent) was longer, i.e., 1.6 ± 1.03 in the control versus 1.35 ± 1.2 days in the study group (p < 0.001). Grade II-IV complications were significantly more (p < 0.009) in control group. There was one common bile duct (CBD) injury in each group. The index bilio-enteric anastomosis for CBD injury in control group failed and needed a revision with multiple interventions. There was one grade V adverse outcome, i.e., mortality in the control group. CONCLUSION: Avoiding the use of ED in LC is associated with better outcomes.