Intussusception after Rotavirus Vaccine Introduction in India.

BACKGROUND: A three-dose, oral rotavirus vaccine (Rotavac) was introduced in the universal immunization program in India in 2016. A prelicensure trial involving 6799 infants was not large enough to detect a small increased risk of intussusception. Postmarketing surveillance data would be useful in assessing whether the risk of intussusception would be similar to the risk seen with different rotavirus vaccines used in other countries. METHODS: We conducted a multicenter, hospital-based, active surveillance study at 27 hospitals in India. Infants meeting the Brighton level 1 criteria of radiologic or surgical confirmation of intussusception were enrolled, and rotavirus vaccination was ascertained by means of vaccination records. The relative incidence (incidence during the risk window vs. all other times) of intussusception among infants 28 to 365 days of age within risk windows of 1 to 7 days, 8 to 21 days, and 1 to 21 days after vaccination was evaluated by means of a self-controlled case-series analysis. For a subgroup of patients, a matched case-control analysis was performed, with matching for age, sex, and location. RESULTS: From April 2016 through June 2019, a total of 970 infants with intussusception were enrolled, and 589 infants who were 28 to 365 days of age were included in the self-controlled case-series analysis. The relative incidence of intussusception after the first dose was 0.83 (95% confidence interval [CI], 0.00 to 3.00) in the 1-to-7-day risk window and 0.35 (95% CI, 0.00 to 1.09) in the 8-to-21-day risk window. Similar results were observed after the second dose (relative incidence, 0.86 [95% CI, 0.20 to 2.15] and 1.23 [95% CI, 0.60 to 2.10] in the respective risk windows) and after the third dose (relative incidence, 1.65 [95% CI, 0.82 to 2.64] and 1.08 [95% CI, 0.69 to 1.73], respectively). No increase in intussusception risk was found in the case-control analysis. CONCLUSIONS: The rotavirus vaccine produced in India that we evaluated was not associated with intussusception in Indian infants. (Funded by the Bill and Melinda Gates Foundation and others.).

Rapid vs. Slow Rewarming for Management of Moderate to Severe Hypothermia in Low-Birth-Weight Pre-term Neonates-An Open Label Randomized Controlled Trial.

BACKGROUND: Evidence is lacking regarding the optimal method of rewarming hypothermic low-birth-weight (LBW) pre-term neonates. We aim to evaluate the effect of rapid vs. slow rewarming in the management of moderate to severe hypothermia in LBW pre-term neonates. METHODS: In this open label, randomized controlled trial, 100 LBW (<2.5 kg), pre-term (<37 weeks) neonates with moderate to severe hypothermia (<36°C) was randomized to two groups of 50 each and received either rapid (at >0.5°C/h) or slow (at ≤0.5°C/h) rewarming rate till normothermia. The primary outcome was stabilization score [TOPS (temperature, oxygenation, perfusion and saturation) and MSNS (modified sick neonatal score)] at baseline, 6 and 24 h and mortality until discharge. Other neonatal morbidities were assessed as secondary outcomes. RESULTS: Mean TOPS score and MSNS score at baseline, 6 and 24 h of admission as well as change in score from baseline were similar between the two groups. The median rewarming rate [interquartile range (IQR)] was higher in rapid rewarming group than in the slow rewarming group [5.05°C/h (3.54-7.71) vs. 0.71°C/h (0.60-0.90); p < 0.001]. The median rewarming time taken in rapid rewarming group was lesser compared with that in the slow rewarming group [0.31 h (IQR 0.13-0.75) vs. 2.05 h (IQR 1.11-3.03); p < 0.001]. Mortality in rapid rewarming and slow rewarming group was similar [7/50 vs. 5/50; OR 1.46 (0.43-4.97), p = 0.538]. CONCLUSION: Rapid rewarming was as effective and safe as slow rewarming in the management of moderate to severe hypothermia in LBW pre-term neonates with similar short-term neonatal outcomes. CTRI NUMBER: CTRI/2018/01/011187.

Selenium Supplementation for Prevention of Late-Onset Sepsis in Very Low Birth Weight Preterm Neonates.

BACKGROUND: Neonatal mortality continues to be a significant problem in the Indian setting, especially in very low birth weight (VLBW) neonates. Selenium (Se) has been shown to possess antioxidant properties, and some recent studies have shown a reduction in the sepsis-attributable neonatal mortality with its use. India is a Se-deficient country. Blood Se concentrations in newborns are lower than those of their mothers and lower still in preterm infants. OBJECTIVE: To evaluate the efficacy of Se in preventing the first episode of late-onset sepsis in VLBW preterm neonates. METHODS: Ninety neonates weighing <1500 g and period of gestation <32 weeks, asymptomatic at birth and admitted to the neonatal intensive-care unit (NICU) in the first 12 h of birth with no maternal risk factors for sepsis were analyzed in the study. Se or placebo was supplemented orally once daily from 1st to 28th day of life to the test (n = 45) or control (n = 45) groups, respectively, followed by daily clinical assessment for signs or symptoms of sepsis in the hospital and weekly after discharge. RESULTS: Preterm VLBW neonates (mean birth weight 1464.22 ± 50.14 g and mean gestational age 221.75 ± 4 days) are Se deficient at birth, with mean (SD) Se levels 31.1 ± 14.8 µg/l. Se supplementation at 10 µg/day increased serum Se levels significantly (63.9 ± 13.9 µg/l on Day 28 in Se vs. 40.9 ± 17.3 on Day 28 in placebo; p < 0.01). The incidence of the first episode of culture-proven late-onset sepsis was significantly lower in the Se than in the placebo group. [0/45 (0%) in Se vs. 6/45 (13.3%) in placebo; p = 0.033]. The incidence of probable sepsis was found to be significantly lower in the Se group [7/45 (15.55%)] than in the placebo [16/45 (35.55%)]; p = 0.02. The total incidence of any late-onset sepsis (i.e. culture-proven plus probable sepsis) was also significantly reduced by Se supplementation. [7/45 (15.55%) in Se vs. 22/45 (48.88%) in placebo; p = 0.001]. CONCLUSION: Preterm VLBW neonates are Se deficient at birth. Se supplementation at 10 µg/day resulted in getting the Se levels into the acceptable normal level and reduced the incidence of the first episode of late-onset sepsis in these neonates.

Selenium supplementation for the preterm Indian neonate.

Deficient antioxidant defenses in preterm infants have been implicated in diseases such as bronchopulmonary dysplasia, retinopathy of prematurity, necrotizing enterocolitis, periventricular leukomalacia, and intraventricular hemorrhage. The antioxidant properties of selenium make it important in the nutrition of very low-birth weight (VLBW) infants. Selenium is a component of glutathione peroxidase (GPX), an enzyme that prevents the production of free radicals. Preterm infants have low selenium stores and require supplementation by parenteral and enteral routes. This communiquι reviews the beneficial role that selenium supplementation might play in improving neonatal outcomes.

Efficacy of Bovine Lactoferrin Supplementation in Preventing Late-onset Sepsis in low Birth Weight Neonates: A Randomized Placebo-Controlled Clinical Trial.

OBJECTIVES: To evaluate the efficacy of bovine lactoferrin (BLF) in preventing first episode of late-onset sepsis (LOS) in low birth weight (LBW) neonates. METHODS: In this study conducted from May 2012 to July 2013 in the neonatal intensive care unit (NICU) of a tertiary care hospital, inborn asymptomatic neonates, <2000 g, admitted to NICU in first 12 h of birth with no maternal risk factors for sepsis were randomized to receive BLF or placebo from 1st to 28th day of life. The incidence of culture-proven sepsis and sepsis-attributable mortality after 72 h of life was recorded. Increasing doses of BLF were used with higher birth weights. RESULTS: Incidence of first episode of culture-proven LOS was significantly lower in the BLF group vs. placebo [2/63 (3.2%) vs. 9/67(13.4%); risk ratio, 0.211; 95% CI, 0.044-1.019; p = 0.036]. Statistically significant reduction in the sepsis-attributable mortality was also seen after use of prophylactic BLF [0/63 (0%) vs. 5/67 (7.5%); p = 0.027]. CONCLUSION: BLF supplementation in LBW neonates reduced the incidence of first episode of LOS.

Effect of topical application of chlorhexidine for umbilical cord care in comparison with conventional dry cord care on the risk of neonatal sepsis: a randomized controlled trial.

AIM: To compare topical application of chlorhexidine for umbilical cord care with conventional dry care for prevention of neonatal sepsis in neonatal intensive care unit (NICU). METHODS: The study was conducted in the NICU of a teaching hospital in north India between 2010 and 2011. Newborns (≥ 32 weeks of gestation and weighing ≥ 1500 g) were randomized into chlorhexidine application and dry care groups. Data regarding time of cord separation, umbilical sepsis and neonatal sepsis were recorded. RESULTS: One hundred forty (dry care group 70, chlorhexidine group 70) were enrolled and finally analysed. A significant difference was observed among groups in terms of time to cord separation and incidence of blood culture-proven sepsis though there was no statistical difference noted among the groups with regards to umbilical infection, probable sepsis and meningitis. CONCLUSION: Use of chlorhexidine for umbilical cord care prevents sepsis in the NICU.

Recombinant human granulocyte colony-stimulating factor in preterm neonates with sepsis and relative neutropenia: a randomized, single-blind, non-placebo-controlled trial.

We performed a prospective, randomized, single-blind, non-placebo-controlled trial on preterm (<37 weeks) neonates (birth weight <2000g) with sepsis and absolute neutrophil counts (ANC) <5000 cells mm(-3) to study the effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) on all-cause-neonatal mortality and hematological parameters (total leucocyte (TLC, ANC, absolute monocyte and absolute platelet counts). The rhG-CSF group (n = 20) received 10 µg/kg/day of intravenous infusion of rhG-CSF once daily for 5 days along with conventional therapy, and the control group (n = 20) received conventional therapy alone. Hematological parameters on Days 0, 1, 3, 5, 7 and 14 of study entry and all-cause mortality rates at discharge were recorded. Baseline characteristics between the rhG-CSF and control group including mean birth weight (1395 ± 289 vs. 1500 ± 231g), mean gestational age (31.5 ± 2.68 vs. 32.6 ± 2.23 weeks), initial neonatal complaints and maternal characteristics were comparable. Mortality rates were significantly less among the rhG-CSF group (3/20 (15%) vs. 7/20 (35%), p < 0.05). By Day 5 (for TLC) and Day 3 (for ANC) of start of the intervention, rhG-CSF group had significantly higher TLC (8189 ± 1570 vs. 6936 ± 1128 cells mm(-3), p < 0.05) and ANC (4756 ± 1089 vs. 4213 ± 354 cells mm(-3), p < 0.05) compared to controls. ANC levels recovered to levels >5000 cells mm(-3) faster in the rhG-CSF group, with 80% babies having ANC >5000 cells mm(-3) by Day 7 of study entry compared with 35% in the control group (p < 0.05). Preterm neonates with sepsis and neutropenia treated with rhG-CSF adjunctive therapy have decreased all-cause mortality at discharge and a quicker recovery of their total leucocyte and ANC.

Transport characteristics and predictors of mortality among neonates referred to a tertiary care centre in North India: a prospective observational study.

OBJECTIVE: The paucity of specialised care in the peripheral areas of developing countries necessitates the referral of sick neonates to higher centres. Organised interhospital transport services provided by a skilled and well-equipped team can significantly improve the outcome. The present study evaluated the transport characteristics and predictors of mortality among neonates referred to a tertiary care centre in North India. DESIGN: Prospective observational study. SETTINGS: Tertiary care teaching hospital in North India. PATIENTS: 1013 neonates referred from peripheral health units. MAIN OUTCOME MEASURES: Mortality among referred neonates on admission to our centre. RESULTS: Of the 1013 enrolled neonates, 83% were transferred through national ambulance services, 13.7% through private hospital ambulances and 3.3% through personal vehicles. Major transfer indications were prematurity (35%), requirement for ventilation (32%), birth asphyxia (28%) and hyperbilirubinaemia (19%). Hypothermia (32.5%, 330 of 1013), shock (19%, 192 of 1013) and requirement for immediate cardiorespiratory support (ICRS) (10.4%, 106 of 1013) on arrival were the major complications observed during transfer. A total of 305 (30.1%, N=1013) deaths occurred. Of these, 52% (n=160) died within 24 hours of arrival. On multivariate logistic analysis, unsupervised pregnancy (<4 antenatal visits; p=0.037), antenatal complications (p<0.001), prematurity ≤30 weeks (p=0.005), shock (p=0.001), hypothermia (p<0.001), requirement for ICRS on arrival (p<0.001), birth asphyxia (p=0.004), travel time >2 hours (p=0.005) and absence of trained staff during transfer (p<0.001) were found to be significant predictors of mortality. CONCLUSION: The present study depicts high mortality among infants referred to our centre. Adequate training of peripheral health personnel and availability of pre-referral stabilisation and dedicated interhospital transport teams for sick neonate transfers may prove valuable interventions for improved outcomes.

Gastroenteritis in Haryana, India Post Introduction of Rotavirus Vaccine.

OBJECTIVE: To evaluate the epidemiology of rotavirus gastroenteritis in Haryana post-introduction of rotavirus vaccine. Expanded National rotavirus surveillance network in India reported high burden of rotavirus diarrhea in India. The Government of India introduced the monovalent rotavirus vaccine made in India by Bharat Biotech in the national immunization programme from 2016 onward along with oral polio vaccine (OPV) and Pentavalent vaccines. METHODS: A multi-centric, hospital-based surveillance study in the initial vaccine introducing states was started in a phased manner over a period of 3 y. PGIMS, Rohtak is a tertiary care center and was a part of the surveillance from 2016 to 2019. Children aged 0-59 mo admitted with acute gastroenteritis were enrolled into the surveillance and their stool samples were collected. Samples were tested at Christian Medical College (CMC), Vellore to detect rotavirus and reverse transcription-polymerase chain reaction (RT-PCR) was used for G and P typing. RESULTS: A total of 904 children were enrolled in the present surveillance over a period of 3 y starting 1st July 2016 to 30th June 2019. Stool samples were collected and analyzed for 827 children and out of them 141 samples were positive for rotavirus (17.1%). Maximum rotavirus positivity was observed during the winter months. Rotavirus positivity percentage was observed maximum in 12-23 mo age group. A declining trend was observed in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019. Most common strains of rotavirus isolated were G3P[8] followed by G1P[8]. CONCLUSION: This study highlights that epidemiology of acute gastroenteritis among children less than 5 y of age in Haryana postintroduction of rotavirus vaccination in the state and the decline in rotavirus positivity from 22.8% in 2016 to 14.5% in 2019.

Enhancing Kangaroo Mother Care Uptake Through Implementation of an Education Protocol.

OBJECTIVES: Kangaroo mother care (KMC) uptake is low despite KMC being an evidence based tool to decrease neonatal mortality. It is important that local strategies be developed to enhance KMC usage. This study aimed to assess the effect of implementing an education protocol on the usage of KMC in the NICU and at home after discharge. METHODS: Preterm mother-infant dyads admitted to the NICU were enrolled prospectively. In initial 3 mo, baseline data on KMC usage in the unit and at home after discharge was collected. In the next three months, a KMC education protocol consisting of one-to-one counseling, education and sensitization of the mother and family members regarding benefits and procedure of KMC and focussed group discussions was implemented such that it became a unit work protocol. In the next 3 mo, data on KMC usage in the unit and at home after discharge was again collected and compared with the baseline data. RESULTS: Implementation of the education protocol resulted in earlier initiation of KMC (2.49 ± 0.67 vs. 4.65 ± 0.99 d, p < 0.05); increased duration of KMC (8 h/d vs. 3 h/d, p < 0.05); a higher proportion of eligible preterms receiving KMC during hospital stay (100% vs. 75%, p < 0.05) and at home (87% vs. 28%, p < 0.05) and KMC being provided more often by other family members (27.1% vs. 5.7%, p < 0.05). CONCLUSIONS: Implementation of a KMC education protocol resulted in improved KMC usage in the unit and at home 4 wk after discharge.

Epidemiology of Hospitalized Intussusception Cases from Northern States in India.

OBJECTIVE: To describe epidemiology of intussusception post-introduction of the rotavirus vaccine. METHODS: Hospital-based active surveillance system was set up in three tertiary care hospitals in Chandigarh and Haryana, India, to enroll children <2 y of age admitted with intussusception as per Brighton Collaboration Level-I criteria. The clinical characteristics, treatment modalities, seasonal trends, and outcome of the illness episodes were described. RESULTS: A total of 224 cases were reported. Majority were males (71%) and infants (69.5%). Number of intussusception was more in summer season. Location of intussusception was ileo-colic in 85% of the cases. Nearly 54% cases were treated conservatively and 46% needed surgical intervention. CONCLUSION: Surveillance data provided the epidemiological description of intussusception cases post-introduction of the rotavirus vaccine in northern India. This data could be used to assess the impact of vaccine and safety with a special focus on intussusception.

Comparison of efficacy of a 7-day versus a 14-day course of intravenous antibiotics in the treatment of uncomplicated neonatal bacterial sepsis: study protocol of a randomized controlled non-inferiority trial.

BACKGROUND: Neonatal sepsis is a global public health problem. There is no consensus regarding the optimum duration of antibiotics for culture-proven neonatal sepsis. Published randomized controlled trials (RCTs) comparing shorter versus longer courses of antibiotics provide low-quality evidence with serious risk of bias. We hypothesized that among neonates with uncomplicated culture-proven sepsis, antibiotic duration of 7 days is not inferior to 14 days. METHODS: This is a multi-centric, parallel-group, stratified, block-randomized, active-controlled, non-inferiority trial with outcome assessment blinded. Stratification is by center and birth weight. Neonates weighing ≥1000 g at birth, with blood-culture-proven sepsis (barring Staphylococcus aureus and fungi), without conditions warranting > 14 days antibiotics, and who clinically remit, are enrolled in the RCT on day 7 of administration of sensitive antibiotics. They are randomly allocated to no further antibiotics (intervention arm: total 7 days) or 7 more days of the same antibiotics (control arm: total 14 days). Allocation is concealed by opaque, sealed envelopes. The primary outcome is "definite or probable relapse" within 21 days after antibiotic completion. Secondary outcomes include definite and probable relapses at various timepoints until day 35 post-randomization, secondary infections, and adverse events. The neonatologist adjudicating probable relapses and lab personnel are blinded. Three hundred fifty subjects will be recruited in each arm, assuming a non-inferiority margin of 7%, one-sided alpha error 5%, and power of 90%. Analysis will be per protocol and by intention-to-treat. An independent Data Safety Monitoring Board monitors adverse events and will perform one interim analysis when 50% of expected primary outcomes have occurred or 50% of subjects have completed follow-up, whichever is earlier. O'Brien-Fleming criteria will be used to stop for mid-term benefit and Pocock's to stop for mid-term harm. A priori subgroup analyses are planned by birth weight categories, gram-stain status of pathogens, and radiological pneumonia. DISCUSSION: This trial will provide evidence to guide practice regarding optimum duration of antibiotics for culture-proven neonatal bacterial sepsis. If a 7-day regime is proved to be non-inferior to a 14-day regime, it is likely to reduce hospital stay, costs, adverse effects of drugs, and nosocomial infections. TRIAL REGISTRATION: Clinical Trials Registry India CTRI/2017/09/009743 . Registered on 13 September 2017.

Rotavirus Strain Distribution before and after Introducing Rotavirus Vaccine in India.

In April 2016, an indigenous monovalent rotavirus vaccine (Rotavac) was introduced to the National Immunization Program in India. Hospital-based surveillance for acute gastroenteritis was conducted in five sentinel sites from 2012 to 2020 to monitor the vaccine impact on various genotypes and the reduction in rotavirus positivity at each site. Stool samples collected from children under 5 years of age hospitalized with diarrhea were tested for group A rotavirus using a commercial enzyme immunoassay, and rotavirus strains were characterized by RT-PCR. The proportion of diarrhea hospitalizations attributable to rotavirus at the five sites declined from a range of 56-29.4% in pre-vaccine years to 34-12% in post-vaccine years. G1P[8] was the predominant strain in the pre-vaccination period, and G3P[8] was the most common in the post-vaccination period. Circulating patterns varied throughout the study period, and increased proportions of mixed genotypes were detected in the post-vaccination phase. Continuous long-term surveillance is essential to understand the diversity and immuno-epidemiological effects of rotavirus vaccination.

Ten days vs. 14 days antibiotic therapy in culture-proven neonatal sepsis.

BACKGROUND: There are no evidence-based guidelines for the treatment of neonatal sepsis although standard text books recommend 14 days of antibiotics for blood culture-proven neonatal sepsis. OBJECTIVE: The present study compared the effectiveness of a 10-day course of antibiotic therapy with the conventional 14-day course in blood culture-proven neonatal sepsis. METHODS: Infants ≥ 32 weeks and ≥ 1.5 kg weight with blood culture-proven sepsis were randomized to either 10-day (study group) or 14-day (control group) therapy on Day 7 of appropriate antibiotic therapy, if they were in clinical remission and were C-Reactive Protein (CRP) negative. The primary outcome was treatment failure within 28 days defined by either positive CRP or positive blood culture or clinical relapse. RESULTS: The baseline characteristics were comparable between the two groups. There was one treatment failure in each group. The duration of hospital stay was significantly shorter in the 10-day treatment group. CONCLUSION: Ten-day antibiotic therapy is as effective as 14-day therapy in blood culture-proven neonatal sepsis, if the infant has achieved clinical remission by Day 7 of therapy.

Safety and efficacy of vinyl bags in prevention of hypothermia of preterm neonates at birth.

The present study was planned to evaluate the safety and efficacy of vinyl bags in prevention of hypothermia during resuscitation at birth in very low birth weight neonates. Sixty neonates of gestational age ≤32 weeks and birth weight ≤ 1500gm were randomised to either study group, or control group. Study group neonates were put in vinyl bags up to neck and the head was covered with a cap after drying immediately following delivery and resuscitated under radiant warmer. Control group neonates were resuscitated by conventional drying under radiant warmer. Mean axillary and rectal temperature recorded immediately after admission to NICU were significantly higher in the study group compared to control group. Temperature recorded after 1 hour of admission to NICU were however comparable between the two groups. As temperature maintenance in these VLBW neonates is of tremendous importance, it would make sense to recommend the use of vinyl bags during their resuscitation.

Clinical profile and predictors of mortality among the referred neonates at a tertiary care centre in north India: a prospective observational study.

The National Family Health Survey (NFHS-4) shows encouraging improvement in infant and under-five mortality rates in India. However, the neonatal mortality rate (NMR) still remains high as India contributes to about one-fifth of global deaths. This prospective study was conducted from 15 January to 30 April 2016 to examine the clinical profile and predictors of mortality among referred neonates at our centre. Among 301 neonates, prematurity (40%) was the most common indication for referral followed by need for ventilation (38%) and birth asphyxia (28%). Approximately 73% neonates were referred within 24 h of birth. Ninety (29.9%) neonates died; of these, 63% died within 24 h of presentation. Prematurity, birth asphyxia, hypothermia, shock at presentation and extreme low birth weight were the most significant predictors of mortality. Adequate training of peripheral health personnel, dedicated teams for neonatal referral and strengthening of peripheral sick newborn care units (SNCUs) seem to be promising interventions for favourable outcome.

Longitudinally Extensive Transverse Myelitis (LETM) Following Varicella Infection in a 13-Year Immunocompetent Child.

Varicella infection in children is a common self-limited illness with neurological complications in less than 0.1% of cases. Longitudinally extensive transverse myelitis (LETM) is uncommon in children following infection with varicella-zoster virus. We describe a case of 13-yr immunocompetent girl with LETM following varicella infection shown a dramatic clinical response to a combination of acyclovir and pulse steroids.

Cognitive and Behavioral Profile of Treatment-Naïve Children Aged 6-14 Years with Neurocysticercosis from North India.

BACKGROUND: Neurocysticercosis (NCC) produces a progressive organic brain damage by altering brain function with alterations in memory, difficulties in learning, and behavioral changes. The present study was designed to compare the cognitive and behavioral profile of school-going children aged 6-14 years with newly diagnosed NCC with their age-matched controls. MATERIALS AND METHODS: A descriptive cross-sectional study was conducted among children aged 6-14 years with newly (<7 days) diagnosed NCC. Age- and gender-matched typically developing children with minor illness attending outpatient facility served as control. Intelligence and behavioral assessment were performed using Malin's Intelligence Scale for Indian Children and Childhood Behavior Checklist (CBCL) (school age version CBCL/6-18). CBCL T-scores were computed and scores < 60 were considered as normal, 60-63 as borderline, and > 63 as clinical range. RESULTS: A total of 35 cases and 35 controls were enrolled. Baseline demographic characteristics were comparable between the two groups. Verbal intelligence quotient (IQ) scores were comparable between the cases (96.14 [10.23]) and controls (100.17 [10.89]) (P = 0.11). The behavioral assessment revealed normal T-scores (<60) in both the groups. CONCLUSIONS: The study revealed comparable IQ and normal behavioral profile of treatment-naïve children with recently diagnosed NCC to their age-matched peers. Further studies with larger sample size and longitudinal study design are required to evaluate the role of NCC on cognition and behavior in Indian children.