Ten Years Analysis of Parental Counselling-in-Continuum in Paediatric Surgery: Psychosocial and Medico-legal Outcome.

BACKGROUND: Parents are anxious and apprehensive about the health of their children. A standardised, reproducible and meticulous parental counselling is helpful to both the parents and the treating doctors, as well as markedly reduces instances of scrimmage and medico-legal litigations. The aim of this study is to assess the psychosocial and medico-legal outcomes of parental counselling-in-continuum (PCiC) in paediatric surgery. MATERIALS AND METHODS: The study was conducted at two government-run Tertiary Healthcare Centres in North India. The study design involves prospective feedback-based study. It included all the admitted paediatric surgery patients. Periodic multisession PCiC was done for each patient by three paediatric surgery teams from 2011 to 2021. At the time of discharge, feedback was taken to assess the psychosocial outcome of PCiC, and the medico-legal outcome was calculated based on the number of litigations. RESULTS: A total of 22,353 admissions were done in paediatric wards at these institutes. 1574 cases were managed conservatively and 20,779 patients who underwent surgeries were included in the study. 4758 (22.89%) were emergency procedures and 16,021 (77.11%) were elective procedures. Parents rated the counselling efforts excellent in 18,285 (81.80%), good in 3162 (14.14%), satisfactory in 876 (3.91%) and poor in 30 (0.13%) cases with zero medico-legal litigations and 12 incidents of scrimmage. CONCLUSIONS: PCiC, being a novel concept, should form a centerpiece of paediatric surgical management as it maximally enhances the patient satisfaction level and protects the treating paediatric surgical team from scrimmage and medico-legal litigations.

Gestational Age-Specific Nomogram of Transcutaneous Bilirubin in First 120 h of Life for Term and Late Preterm Indian Neonates.

OBJECTIVE: To create a nomogram based on transcutaneous bilirubin values (TCB) in first week of life for term and late preterm (>34 weeks) neonates. METHODS AND DESIGN: Prospective longitudinal study. SETTING: Four tertiary-care teaching hospitals (one each in eastern and southern India, two in northern India) between February 2019 and March 2020. PARTICIPANTS: A total of 2492 term and late preterm (>34 weeks) neonates. INTERVENTION: Bilirubin was measured by transcutaneous bilirubinometer (Drager JM-105, Germany) in all neonates in pre-specified times of the day, 12 hourly every day since birth till discharge between 48 and 72 h, and data were recorded in epochs of 6 hourly intervals. Post-discharge, all neonates were called for review in next 48 h. OUTCOME MEASURES: Primary-TCB in first week of life. Secondary-factors having significant association with significant hyperbilirubinaemia requiring phototherapy. RESULTS: Total of 2492 neonates (males 1303 and female 1189), with a total of 14 162 TCB recordings were analysed and mean hourly bilirubin (TCB) at hourly intervals till 120 h and then daily bilirubin values on Days 6 and 7 were tabulated. We have constructed hour-specific bilirubin nomogram with percentiles as per gestational age in term and near-term Indian neonates till 120 h of life. Amongst the known risk factors, delayed cord clamping, primipara and breastfeeding jaundice had significant association for hyperbilirubinaemia needing phototherapy. CONCLUSIONS: We have created gestation-specific nomogram of TCB levels in 6 hourly intervals for the first 120 postnatal hours, obtained from a large predominantly breast fed healthy, term and near-term Indian neonates.

Effect of Delayed Umbilical Cord Clamping on Hemodynamic Instability in Preterm Neonates below 35 Weeks.

INTRODUCTION: Delaying umbilical cord clamping facilitates postnatal transition in neonates but evidence on its effect in reducing hemodynamic instability in preterm neonates is inconclusive. AIMS: To evaluate delayed cord clamping (DCC) in reducing the incidence of hemodynamic instability in preterm neonates below 35 weeks gestational age admitted to the neonatal intensive care unit. METHODS: Neonates between 25 weeks and 34 weeks and 6 days gestation were enrolled. Hemodynamic and respiratory parameters were monitored over 48 h. Hemodynamic instability was defined as persistent tachycardia and/or hypotension necessitating therapy. RESULTS: The DCC cohort included 62 neonates with an equal number in the non-DCC group. The birth weight [mean ± standard deviation (SD)] was 1332.90 ± 390.05 g and the gestational age (mean ± SD) was 31.64 ± 2.52 weeks. Hemodynamic instability was noted in 18/62 (29%) neonates in the DCC cohort and 29/62 (46.7%) in the non-DCC group; relative risk (RR) 0.62 [95% confidence interval (CI) 0.38-0.99] (p = 0.023). The duration of inotrope requirement in the DCC cohort (mean ± SD) was 38.38 ± 16.99 h compared to 49.13 ± 22.90 h in the non-DCC cohort (p = 0.090). Significantly higher systolic, diastolic and mean arterial pressures were noted from 6 h to 48 h in the DCC cohort (p < 0.001). The severity of respiratory distress and FiO2 requirement was also less in the first 24 h. There was no difference in the incidence of patent ductus arteriosus, late-onset sepsis or mortality. CONCLUSION: Delaying umbilical cord clamping at birth by 60 s resulted in significantly lower hemodynamic instability in the first 48 h and higher blood pressure parameters.

Impact of Cerebral Oxygen Saturation Monitoring on Short-term Neurodevelopmental Outcomes in Neonates with Encephalopathy - A Prospective Cohort Study.

BACKGROUND: Near-infrared spectroscopy (NIRS) has been used for monitoring cerebral oxygen saturation (rSO2) in neonates. There is a lack of data from low-middle income countries (LMIC) setting of cerebral rSO2 in neonates with encephalopathy of diverse etiologies. This study aimed to monitor cerebral rSO2 using NIRS in encephalopathic neonates to maintain the rSO2 between 55 to 85 % in the first 72 hours of admission to improve short-term neurodevelopmental outcomes (NDO). MATERIALS AND METHODS: This prospective cohort study enrolled encephalopathic neonates with hypoxic- ischemic encephalopathy (HIE) and non-HIE etiologies into 8 clinical categories. The cerebral rSO2 was monitored and targeted to be between 55 to 85 %, with predefined actions and management alterations over 72 hours. The neurodevelopmental assessment was conducted at 3, 6, and 9-12 months corrected age. Moreover, the motor and mental developmental quotients (MoDQ) (MeDQ) were recorded and compared to historical control. RESULTS: A total of 120 neonates were enrolled and assessed for NDO. The MoDQ (mean ± SD) was 92.55 ± 14.85, 93.80 ± 13.20, 91.02 ± 12.69 and MeDQ (mean ± SD) was 91.80 ± 12.98, 91.80 ± 13.69, 88.41 ± 11.60 at 3, 6 and 9-12 months. The MoDQ and MeDQ scores of the historic cohort at 12 months were 86.35 ± 20.34 and 86.58 ± 18.27. The mean difference [MD (95 %CI)] for MoDQ was - 4.670 (- 8.48 to - 0.85) (p=0.0165) and for MeDQ was - 1.83 (- 5.26 to 1.6) (p=0.29). There was a negative correlation between the composite developmental quotient (CoDQ) with mean rSO2 and a positive correlation with cerebral fractional tissue oxygen extraction (CFTOE). Neonates with HIE and neonatal encephalopathy (NE) (n=37/120) had the lowest motor and mental DQ on neurodevelopmental assessment. Clinical categories, neonatal meningitis (NM), and intraventricular hemorrhage (IVH) improved in DQ scores over the study period. CONCLUSION: Monitoring and maintaining cerebral rSO2 between 55-85 % through appropriate management changes improved neurodevelopmental scores at the 12-month follow-up in neonates with encephalopathy caused by varied etiologies.

Diagnostic Accuracy of Clinical Tool 'STOPS' and Serum Procalcitonin for Optimizing Antibiotic Therapy in Neonates Born at ≥ 28 Weeks of Gestation with Neonatal Sepsis.

BACKGROUND: Antibiotic therapy is initiated in neonates on suspicion of sepsis. Optimizing therapy is a felt need of clinicians as prolonged injudicious use increases mortality and morbidity risk. OBJECTIVE: To evaluate the diagnostic accuracy of clinical tool 'STOPS' and serum procalcitonin (PCT) for identifying neonates with early-onset neonatal sepsis (EONS) or late-onset neonatal sepsis (LONS) and early discontinuation in those with no sepsis. METHODS: The study had a prospective analytical design conducted at a tertiary care hospital. Consecutively admitted neonates with suspected EONS or LONS were enrolled. The 'STOPS' tool comprising sensorium, temperature, oxygenation, perfusion, skin color, and blood sugar was applied at 6 and 12 hours of enrollment. Serum PCT was sent at 12 hr. The sensitivity, specificity, positive and negative predictive value (PPV and NPV), positive and negative likelihood ratio (PLR and NLR) were estimated. RESULTS: The study enrolled 380 neonates, of which 330 were given antibiotics for EONS and 50 for LONS. Temperature disturbance in the EONS group at 12 hr showed a PPV of 100% and a PLR of 9.1 (7.7 - 18). Perfusion assessment at 12 hr had a PPV of 77% and PLR of 8.25 (2.3 - 29). Skin color assessment at 12 hr had a PPV of 100% and PLR of 13.5 (9.7 - 27). The diagnostic accuracy of PCT in the EONS group was unremarkable. In the LONS group, skin color at 12 hr had a PPV of 100% and PLR of 11.2 (8.6 - 19.5). The diagnostic accuracy of PCT in the LONS group showed a PPV of 82% and PLR of 7 (1.7 - 29). CONCLUSION: Identifying abnormal STOPS parameters was superior to PCT alone in EONS and as good as PCT in LONS. The 'STOPS' tool allows early identification of neonates with no sepsis, thereby optimizing antibiotic use.

Proportionate Postnatal Growth in Preterm Neonates on Expressed Breast Milk Feeding With Selected Fortification.

BACKGROUND: Preterm neonates not fed an exclusive human-milk diet in the neonatal intensive care unit (NICU) show disproportionate postnatal growth. There are scant data on postnatal growth in neonates from India fed an exclusive expressed breast milk (EBM) diet. This study describes the postnatal changes in weight, length, and head circumference in preterm neonates given EBM with selected fortification. METHODS: The study had a prospective observational design. Exclusive EBM feeding, early initiation, and standardized progression of feeds was followed. Fortification of breast milk with human milk fortifier (HMF) or liquid calcium phosphate and multivitamins (CALVIT) or hindmilk (HM) was done based on the gestational age. Monitoring for weight, length, and head circumference was done from admission to discharge. RESULTS: Ninety-three preterm neonates were included in the study, of which 34 (36.6%) were small for gestational age. Thirty-two (34.3%) neonates received EBM with HMF, 35 (35.7%) received EBM fortified with CALVIT and 26 (28%) neonates received HM fortification. There was a significant difference in the change in z-scores from birth to discharge for the weight, length, and head circumference (P = .001). The mean increase in daily weight ranged from 8.8 to 9.5 g/d, whereas weekly change in length was 0.8-0.9 cm/wk, and head circumference was 0.7 cm/wk. CONCLUSION: Postnatal growth of preterm neonates during NICU admission on exclusive EBM feeding with selected fortification resulted in a proportionate increase in weight, length, and head circumference.

Evaluation of Rh-Hemolytic Disease in Neonates and Management with Early Intensive Phototherapy in the Neonatal Intensive Care Unit.

BACKGROUND OF THE STUDY: In neonates with Rh-hemolytic disease, light emitting diode (LED) phototherapy allows delivery of high spectral irradiance (SI). A linear correlation exists between SI and efficacy of phototherapy with no saturation point. There is scant data on evaluation and early phototherapy using LED units in Rh-hemolytic disease. OBJECTIVE: This study aimed to describe the hemoglobin (Hb), hematocrit (Hct), total serum bilirubin (TSB), phototherapy parameters and short-term outcomes in neonates with Rh-hemolytic disease. METHODOLOGY: Maternal parameters for Rh-isoimmunization were recorded and monitoring of fetal anemia by Doppler ultrasound was done. Early intensive phototherapy within 1 h of birth was initiated for cord blood Hb below 13.6 g/dl and/or TSB greater than 2.8 mg/dl. RESULTS: Fifty Rh positive neonates were enrolled of which 11/50 (22%) received intrauterine transfusions. The maximum TSB remained below 18 mg/dl in 42/50 (84%) of neonates. The mean SI on the trunk was 56.260 ± 8.768 µW/cm2/nm and duration of phototherapy was 7 ± 3.29 days (mean ± SD). There was a positive correlation between strength of indirect antiglobulin test and cord blood Hb: correlation coefficient (r) = 0.295; direct antiglobulin test and duration of phototherapy: r = 0.331. Early packed red blood cell (PRBC) transfusion was required in 8/50 (16%) neonates while 20/50 (40%) required late transfusions. CONCLUSION: With a mean SI of 56.260 ± 8.768 µW/cm2/nm on the trunk, TSB remained below 18 mg/dl in majority thereby avoiding exchange transfusion. Early or late PRBC transfusion requirement was 1 (1-2) (median ± interquartile range).

Morbidity Patterns of Late Preterm Babies Born Small for Gestation.

OBJECTIVE: To compare hypoglycemia and the other early neonatal morbidities (from birth till hospital discharge) of late preterm babies born small for gestational age (LP SGA) with their appropriate for age (LP AGA) counterparts. METHODS: LP SGA and LP AGA, as defined by Fenton charts, were prospectively followed-up to assess development of predefined morbidities, mortality and readmission rates at one month. All live inborn late preterm babies (340/7 to 366/7 weeks, n = 238) were included. RESULTS: LP SGA babies (n = 72) as compared to LP AGA babies (n = 166) were at higher risk for developing at least one predefined neonatal morbidity before hospital discharge [RR 1.93 (1.6-2.3; p < 0.001)]. These included hypoglycemia, hypothermia, respiratory morbidity needing support, jaundice needing treatment, feeding difficulties, birth asphyxia, and sepsis; besides, significant rates of readmissions and duration of hospital stay. CONCLUSIONS: Being born small for gestation age acts an additional jeopardizing factor in late preterm babies.

Anterior Fontanelle Size in Healthy Indian Late Preterm and Full Term Newborns.

OBJECTIVE: To measure the size of the anterior fontanelle (AF) in healthy late-preterm and term newborns and correlate it with birth weight, gestational age, gender, occipito-frontal circumference, small for gestational age status and birth weight z-score. METHODS: This was an observational study carried out from October 2013 through April 2015 at a tertiary care hospital. Newborns ≥ 34 wk gestation were enrolled. Fontanelle edge was palpated with index finger and size calculated by adding anterior-posterior and transverse diameters and dividing by two. RESULTS: A total of 1010 neonates were enrolled. The mean AF size was 2.23 ± 0.52 cm (mean ± SD). There was a significant decrease in the size of the AF with advancing gestational maturity on one-way ANOVA (F = 31.30) (P < 0.001) and also by increasing birth weight (F = 20.34) (P < 0.001). There was no significant difference in the mean AF size between males; 2.21 ± 0.54 cm and females; 2.25 ± 0.55 cm (mean ± SD) (P = 0.575). There was a strong correlation between AF size with increasing birth weight; correlation (r) = 0.985. In small for gestational age neonates the AF was larger, 2.27 ± 0.55 (mean ± SD) and a strong correlation between birth weight z-score and AF size was noted (r = 1.012). CONCLUSIONS: The mean AF size in late-preterm and term Indian newborns in a mixed community hospital was 2.23 ± 0.52. A strong correlation was found between AF size with increasing birth weight and with birth weight z-score in small for gestational age babies.

Clinical and Hematological Profile of Patients with Dengue Fever at a Tertiary Care Hospital - An Observational Study.

BACKGROUND: Dengue is a major health issue with seasonal rise in dengue fever cases imposing an additional burden on hospitals, necessitating bolstering of services in the emergency department, laboratory with creation of additional dengue fever wards. OBJECTIVES: To study the clinical and hematological profile of dengue fever cases presenting to a hospital. METHODS: Patients with fever and other signs of dengue with either positive NS1 antigen test or IgM or IgG antibody were included. Age, gender, clinical presentation, platelet count and hematocrit were noted and patients classified as dengue fever without warning signs (DF) or with warning signs (DFWS), and severe dengue (SD) with severe plasma leakage, severe bleeding or severe organ involvement. Duration of hospitalization, bleeding manifestations, requirement for platelet component support and mortality were recorded. RESULTS: There were 443 adults and 57 children between 6 months to 77 year age. NS1 was positive in 115 patients (23%). Fever (99.8%) and severe body ache (97.4%) were the commonest presentation. DF was seen in 429 (85.8 %), DFWS in 55 (11%), SD with severe bleeding in 10 (2%) and SD with severe plasma leakage in 6 cases (1.2%). Outpatient department (OPD) treatment was needed in 412 (82%) and hospitalization in 88 (18%). Intravenous fluid resuscitation was needed in 16 (3.2%) patients. Thrombocytopenia was seen in 335 (67%) patients at presentation. Platelet transfusion was needed in 46 (9.2%). Packed red blood cell (PRBC) transfusion was given in 3 patients with DFWS and 10 of SD with severe bleeding. Death occurred in 3 patients of SD with severe plasma leak and 2 patients with SD and severe bleeding. CONCLUSIONS: Majority of DF cases can be managed on OPD basis. SD with severe bleeding or with severe plasma leakage carries high mortality. Hospitals can analyze annual data for resource allocation for capacity expansion.

Early versus Late Enteral Feeding in Preterm Intrauterine Growth Restricted Neonates with Antenatal Doppler Abnormalities: An Open-Label Randomized Trial.

Background of the study: Enteral feeding in preterm neonates with intrauterine growth restriction (IUGR) and absent or reversed end diastolic flow (AREDF) on umbilical artery (UA) Doppler is delayed owing to an increased risk of necrotizing enterocolitis (NEC). Delaying enteral feeding with longer duration of parenteral nutrition (PN) carries an increased risk of sepsis. Objectives: To study early versus late feeding in preterm IUGR neonates for time required to attain sufficient feed volume to discontinue PN and increased risk of NEC or feed intolerance (FI). Design: Open-label randomized controlled trial. Setting: Tertiary care neonatal unit and fetal-maternal medicine unit in India. Participants: Preterm intrauterine growth restricted neonates' ≤32 weeks with AREDF on UA Doppler enrolled from 1 January 2014 to 31 July 2015. Intervention: Randomized to receive early or late feeding using mothers own or donor breast milk as per a feed initiation and advancement protocol. Primary outcome: Time in days required to attain sufficient feed volume allowing discontinuation of PN and incidence of NEC in neonates fed early versus late. Results: There were 77 eligible neonates. Sixty-two neonates were included and stratified as extreme preterm (27-29 weeks) (n = 20) and very preterm (30-32 weeks) (n = 42). Ten extreme preterm and 21 very preterm neonates were randomized to each early feeding and late feeding arm. There was a significantly faster attainment of sufficient feeds in the early feeding arm of both the stratified groups [extreme preterm: median 14 days (Interquartile range IQR: 12-15) compared with 18 days (IQR: 18-20), hazard ratio (HR): 1.59, 95% CI: 0.626-4.078; very preterm: 12 days (IQR: 10-14) as compared with 16 days (IQR 15-17), HR: 1.89, 95% CI: 1.011-3.555]. There was no difference in the incidence of NEC, FI and combined outcome of NEC and FI. Conclusion: Early feeding in preterm IUGR neonates with AREDF on antenatal UA Doppler allowed earlier discontinuation of PN, allowing birth weight to be regained earlier and did not increase the incidence of NEC and FI.

Asparagine Synthetase deficiency-report of a novel mutation and review of literature.

Asparagine synthetase deficiency is a rare inborn error of metabolism caused by a defect in ASNS, a gene encoding asparagine synthetase. It manifests with a severe neurological phenotype manifesting as severe developmental delay, congenital microcephaly, spasticity and refractory seizures. To date, nineteen patients from twelve unrelated families have been identified. Majority of the mutations are missense and nonsense mutations in homozygous or compound heterozygous state. We add another case from India which harbored a novel homozygous missense variation in exon 11 and compare the current case with previously reported cases.

Bacillus clausii for Prevention of Late-onset Sepsis in Preterm Infants: A Randomized Controlled Trial.

BACKGROUND OF THE STUDY: Preterm infants are managed with antibiotics for sepsis, including suspected or probable sepsis. This leads to a delayed and abnormal colonization of the gut with potentially pathogenic organisms and a microbiome, which lacks biodiversity and increases the risk for late-onset sepsis (LOS). Probiotics have been proven to reduce the risk for necrotizing enterocolitis, but evidence for prevention of LOS is inconclusive. Probiotic effect depends also on the strain used, dose and indication for use. This study evaluated Bacillus clausii probiotic administered prophylactically to preterm neonates for prevention of LOS. OBJECTIVES: To study B.clausii given prophylactically to preterm neonates for prevention of LOS. DESIGN: Double-blinded, placebo-controlled, randomized trial. SETTINGS: Tertiary care neonatal unit in India. PARTICIPANTS: Consecutive preterm neonates <34 weeks, admitted from 1 March 2012 to 28 February 2014 were stratified as extreme preterm and very preterm. INTERVENTION: Randomized to receive either probiotic or placebo for 6 weeks, discharge from hospital, death or occurrence of sepsis, whichever was earlier. PRIMARY OUTCOME: Incidence of definite and probable LOS in probiotic group compared with placebo. RESULTS: Of 326 eligible preterm infants, 244 were enrolled and 82 were excluded. Of these, 120 were stratified as extreme preterm and randomized to receive placebo (n = 59) and probiotic (n = 61). Of 124 babies stratified as very preterm, an equal number was randomized to receive placebo (n = 62) and probiotic (n = 62). There was no significant difference in the incidence of LOS between the two arms in the extreme preterm group [29% vs. 23%; relative risk (RR) 1.27; 95% confidence interval (CI) 0.88-1.66; p = 0.36] and the very preterm group (13% vs. 10%; RR 1.33; 95% CI 0.96-1.70; p = 0.32). Full feeds were achieved significantly faster in the probiotic group in both the extreme preterm (RR 0.82; 95% CI 0.74-0.88) and the very preterm (RR 0.67; 95% 0.32-0.77). CONCLUSIONS: Prophylactic administration of B.clausii to preterm neonates did not result in a significant difference in the incidence of LOS as compared with placebo.

Monotherapy with amikacin or piperacillin-tazobactum empirically in neonates at risk for early-onset sepsis: a randomized controlled trial.

BACKGROUND OF THE STUDY: Neonates at risk for early-onset sepsis are started on antibiotics empirically. Antibiotic resistance to conventionally used antibiotics is increasingly being reported. Antenatal maternal antibiotic exposure in this setting contributes to low yield on blood culture drawn at birth, limiting the planning of antibiotics based on culture reports. A head-to-head comparison for selecting the appropriate antibiotic is one strategy. OBJECTIVES: To compare monotherapy with amikacin against piperacillin-tazobactum as an empirical therapy in neonates at risk for early-onset sepsis. DESIGN: Randomized open-label controlled trial with stratification and block randomization. SETTINGS: Tertiary care neonatal unit in India PARTICIPANTS: All consecutive inborn neonates delivered between 01 May 2009 and 30 April 2011 who were ≥28 week gestation and/or ≥1000 g birth weight with risk factors for early-onset sepsis. INTERVENTION: Randomized to receive either amikacin or piperacillin-tazobactum, after stratifying as asymptomatic or symptomatic within 1 h of birth. PRIMARY OUTCOME: Incidence of treatment failure to the allocated antibiotic defined as blood culture isolate reported resistant to the allocated antibiotic or progression of the illness, necessitating a change of antibiotic. RESULTS: Of 204 eligible cases, 187 were enrolled. Seventeen babies were excluded. A total of 128 neonates were stratified as asymptomatic and 59 as symptomatic. In all, 64 of the asymptomatic cases received amikacin and 64 received piperacillin-tazobactum, while 29 symptomatic babies received amikacin and 30 received piperacillin-tazobactum. Five babies had blood culture-positive sepsis, and 28 babies had strong suspicion of sepsis. There was no difference in the treatment failure in the amikacin group (3 of 93; 3.2%) compared with piperacillin-tazobactum group (2 of 94; 2.1%) (p > 0.01) and no difference in the incidence of second infection, fungal sepsis and all-cause mortality at day 7 and 28 between the two study groups (p > 0.01). CONCLUSIONS: Monotherapy with amikacin as an empirical antibiotic did not result in a higher incidence of treatment failure in neonates at risk for early-onset sepsis as compared with piperacillin-tazobactum. Both antibiotics were effective in management of babies with early-onset sepsis.