Recovery From Otitis Media and Associated Factors Among 1- to 6-Year-Old Children in South India: A Longitudinal Study.

BACKGROUND AND OBJECTIVES: This study was aimed at assessing recovery from otitis media (OM) and variables associated with it among 1- to 6-year-old children. Subjects and. METHODS: We assessed 87 children with OM otologically and audiologically. Medicines were prescribed, and medication compliance was ensured. The children were followed up after 3 months to judge the status of OM as resolved or recurrent. Data were statistically analyzed to derive the risk of recurrence of OM with effusion (OME) and acute OM by degree of hearing loss, type of tympanogram, age group, and sex. RESULTS: The overall recurrence rate was 26%. The risk of recurrence was higher for OME (odds ratio [OR]=4.33; 95% confidence interval [CI]: 1.90 to 9.83); at AC auditory brainstem peak V responses up to 40 dBnHL (OR=5.20; 95% CI: 2.05 to 13), 50 dBnHL (OR=3.47; 95% CI: 0.5 to 23), and 60 dBnHL (OR=16.09; 95% CI: 4.36 to 1.2); in B (OR= 3.16; 95% CI: 1.36 to 7.33) and C tympanograms (OR=2.83; 95% CI: 0.70 to 11.41); and in the age group of 5-6 years (OR=8, 95% CI: 2.23 to 28). The risk of recurrence of OM did not differ between male and female patients. CONCLUSIONS: The rate of recurrence was comparable to or lower than that reported in the pediatric population of other countries. The findings suggest that children with OME, severe pathology, or age of 5-6 years require more attention and frequent monitoring to minimize the risk of recurrence.

Safety and immunogenicity of an indigenously developed tetanus toxoid, diphtheria toxoid, and acellular pertussis vaccine (Tdap) in adults, adolescents, and children in India.

BACKGROUND: This study assessed safety and immunogenicity of Serum Institute of India Pvt Ltd (SIIPL)'s tetanus toxoid (TT), diphtheria toxoid (DT), and acellular pertussis booster vaccine (Tdap). RESEARCH DESIGN AND METHODS: In this Phase II/III, multicenter, randomized, active-controlled, open-label study, 1500 healthy individuals, aged 4-65 years, were randomized to receive a single dose of SIIPL Tdap or comparator Tdap vaccine (Boostrix®; GlaxoSmithKlines, India). Adverse events (AEs) during initial 30 minutes, 7-day, 30-day post-vaccination were assessed. Blood samples were taken before and 30 days post-vaccination for immunogenicity assessment. RESULTS: No significant differences in incidence of local and systemic solicited AEs were observed between the two groups; no vaccine-related serious AEs were reported. SIIPL Tdap was non-inferior to comparator Tdap in achieving booster responses to TT and DT in 75.2% and 70.8% of the participants, respectively, and to pertussis toxoid (PT), pertactin (PRN), and filamentous hemagglutinin (FHA) in 94.3%, 92.6%, and 95.0% of the participants, respectively. Anti-PT, anti-PRN, and anti-FHA antibody geometric mean titers in both the groups, were significantly higher post-vaccination compared to pre-vaccination. CONCLUSIONS: Booster vaccination with SIIPL Tdap was non-inferior to comparator Tdap with respect to immunogenicity against tetanus, diphtheria, and pertussis and was well tolerated.

Diagnostic Yield of Five Minutes Compared to Three Minutes Hyperventilation During Electroencephalography in Children.

Purpose: To investigate whether hyperventilation (HV) for 5 minutes increases the diagnostic yield of electroencephalography (EEG) compared to 3 minutes HV and to determine whether performing HV for 5 minutes is feasible and safe in children. Methods: Data were evaluated from 579 children aged less than 18 years, referred to EEG for epilepsy evaluation. Occurrence of seizures, HV induced interictal epileptiform discharges precipitation and potentiation and adverse events if any were noted during the first 3 minutes and last 2 minutes of HV separately. Results: 398 children (68.7%) completed 5 minutes HV. Seizures were precipitated during the first 3 minutes of HV in 2 children, and during the last 2 minutes in one more child. Inter-ictal EEG abnormalities were precipitated in the first 3 minutes of HV in 31 children, and during the last 2 min in 4 more children. All 398 children completed HV during the last 2 minutes successfully and no adverse events occurred during the last 2 minutes of HV. Conclusion: 33.33% of seizures and 11.5% of inter-ictal EEG abnormalities triggered by HV occurred during the last 2 min of HV. This finding supports the utility of prolonged hyperventilation for 5 minutes. Prolonged HV for 5 minutes increases the diagnostic yield of EEG in paediatric population and it is safe and feasible.

Treatable Cause of Refractory Seizures in an Infant with a Novel Mutation.

Pyridoxine-dependent epilepsy is a treatable cause of epilepsy, which is very well known. It is most commonly caused by mutations in ALDH7A1 and PNPO genes. A 5-month-old infant presented with refractory seizures. Magnetic resonance imaging (MRI) brain was normal. Clinical exome sequencing showed a novel mutation in PROSC gene. He responded very well to pyridoxine and has been seizure free since the beginning of the treatment. PROSC gene mutations have been recently described as a cause for pyridoxine-dependent epilepsy. Here, we describe a first case report of PROSC mutation from India with a rare genetic variant presenting as pyridoxine-dependent epilepsy.

Incidence of Cardiac Manifestations in Children with Dengue Fever: A Cross-sectional Study.

OBJECTIVE: The aim of our study was to explore the incidence of cardiac involvement in children with dengue infection admitted in a tertiary care hospital and to evaluate the features of cardiac involvement with the severity of dengue fever. METHODS: This was a cross-sectional study conducted from September 2014 to August 2016. A total of 130 patients with confirmed dengue NS1 antigen or IgM antibody positivity between the ages of 1 month and 18 years were evaluated. On the third day of admission, blood samples for cardiac markers were collected, and electrocardiograms (ECG) and echocardiograms were performed for each patient. RESULTS: Of the 130 dengue patients in the study, 60 (46.2%) were males and 70 (53.8%) were females (male to female ratio, 1:1.16). Cardiac involvement was present in 60 (46.2%) children and was more prominent in children with severe dengue (72.7%), followed by dengue with warning symptoms (53.8%) and dengue fever (28.6%). There was no significant correlation between cardiac involvement and primary/secondary dengue. Both ECG and echocardiography changes were significantly correlated with dengue severity, as opposed to cardiac markers. CONCLUSIONS: Cardiac involvement was present in children with dengue. Evaluation with ECG, echocardiography, and cardiac markers such as creatine phosphokinase-myocardial band (CPK-MB) are required for the management of cardiac complications in children with dengue. Our study showed an association between cardiac involvement and the severity of dengue. Further studies should be framed, and follow-up of dengue patients with cardiac involvement is necessary for therapeutic management.

Effectiveness of Bedside Clinical Screening Tools in Predicting Short-Term Neurodevelopmental Delay Among Very-Low-Birth-Weight Pre-terms: A Prospective Observational Study.

BACKGROUND: Pre-term births are associated with increased risk of various morbidities, especially neurological. Early detection and early intervention to prevent these morbidities will have immediate and long-term benefits to the individuals and society at large. However, the screening and assessment tools, including both clinical and radiological, are not uniformly available in resource-poor settings. The present study was carried out to evaluate the validity of the clinical screening tools for detecting neurodevelopmental delay among very-low-birth-weight (VLBW) pre-term babies. METHODS: This prospective observational study was undertaken in the child development unit of a tertiary care hospital from July 2015 to October 2017. All pre-term VLBW neonates admitted in level III Neonatal Intensive Care within the first 24 hours of life were included in the study. They were subjected to Hammersmith Neonatal Neurological Examination (HNNE) and magnetic resonance imaging (MRI) of brain at term-equivalent age. Subsequently, the same group was followed up with Amiel-Tison (AT) angles, Child Development Centre (CDC) grading for sitting developed at Trivandrum, Kerala, India, and Denver Development Screening Test (DDST-II gross motor) at eight months corrected age, and their outcomes were analyzed. RESULTS: 17.9% of the ex-preterm were abnormal as per HNNE evaluation at term-corrected age. At short-term follow-up screening, 13.8% were found to be abnormal based on AT angles, while 35.2% were found to be abnormal as per CDC grading and 30.4% were found to have risk for delay as per DDST-II (gross motor). A high level of sensitivity (93.6%) and positive predictive value (91.2%) was observed for HNNE at term equivalent with MRI brain assessment considered as gold standard. Among the follow-up screening tools, CDC grading for sitting, AT angles, and DDST-II had high sensitivity (>85%). CONCLUSION: The combination of HNNE along with radiological assessment at term-corrected age can be considered as appropriate for predicting long-term neurodevelopmental outcome in VLBW pre-term infants. During follow-up, simple tools like CDC grading for motor milestones, AT angles, and DDST-II may be utilized if facilities for standard assessment are not available as in resource-poor settings.

Study to assess the knowledge of caretakers regarding corticosteroid therapy in children with congenital adrenal hyperplasia - 21 hydroxylase deficiency.

BACKGROUND: The primary aim of treating congenital adrenal hyperplasia (CAH) due to 21 hydroxylase deficiency is to replace the deficient glucocorticoids and mineralocorticoids, to minimize the excess androgen production and to facilitate normal growth. Children with CAH require daily treatment lifelong and increased dosage plan during acute stress, in order to obtain the benefit of optimal outcome from the ongoing treatment schedule. This emphasizes the need for the parents of affected children to be empowered with adequate knowledge regarding such lifesaving therapy. AIMS & OBJECTIVES: This study was aimed to assess their knowledge regarding corticosteroid therapy. Materials and methods. Caretakers of children with CAH were recruited by using purposive sampling technique. Data was collected by using structured interview technique. RESULTS: It was observed that only 10% of study group had adequate knowledge about therapy and the majority of them were from rural areas, lacking in awareness of essential steps of management. CONCLUSION: It was concluded that these caretakers need to be given appropriately planned education regarding corticosteroids, drug actions, and the need for enhanced steroid dosage during stress situations. They should also be given relevant instructional materials to read for improving their knowledge about their child's disorder.

EEG for children with complex febrile seizures.

BACKGROUND: Febrile seizures can be classified as simple or complex. Complex febrile seizures are associated with fever that lasts longer than 15 minutes, occur more than once within 24 hours, and are confined to one side of the child's body. It is common in some countries for doctors to recommend an electroencephalograph (EEG) for children with complex febrile seizures. A limited evidence base is available to support the use of EEG and its timing after complex febrile seizures among children. OBJECTIVES: To assess the use of EEG and its timing after complex febrile seizures in children younger than five years of age. SEARCH METHODS: For the latest update of this review, we searched the following databases on 12 March 2019: Cochrane Register of Studies (CRS Web), which includes the Cochrane Epilepsy Group Specialized Register and the Cochrane Central Register of Controlled Trials (CENTRAL); MEDLINE (Ovid, 1946 to 11 March 2019); and ClinicalTrials.gov. We applied no language restrictions. SELECTION CRITERIA: All randomised controlled trials (RCTs) that examined the utility of an EEG and its timing after complex febrile seizures in children. DATA COLLECTION AND ANALYSIS: The review authors selected and retrieved the articles and independently assessed which articles should be included. Any disagreements were resolved by discussion and by consultation with the Cochrane Epilepsy Group. We applied standard methodological procedures expected by Cochrane. MAIN RESULTS: Of 48 potentially eligible studies, no RCTs met the inclusion criteria. AUTHORS' CONCLUSIONS: We found no RCTs as evidence to support or refute the use of EEG and its timing after complex febrile seizures among children under the age of five. An RCT can be planned in such a way that participants are randomly assigned to the EEG group and to the non-EEG group with sufficient sample size. Since the last version of this review, we have found no new studies.

A study on carotid artery intima-media thickness and metabolic risk factors in overweight and obese Indian children.

INTRODUCTION: Carotid intima-media thickness (CIMT) serves as an early marker of atherosclerosis. Data on obesity-related risk factors and their association with carotid intima-media thickness among overweight and obese children are lacking. OBJECTIVES: To compare CIMT of overweight and obese children with CIMT of normal BMI children. To compare various anthropometric and metabolic risk factors associated with increased CIMT among overweight and obese children. METHODS: A descriptive study in a paediatric department of a tertiary care hospital including 50 age-matched normal BMI children and 50 overweight and obese children. Anthropometric data, blood pressure, CIMT (by B-mode ultrasonography), fasting blood sugar, fasting Insulin, fasting lipid profile, TSH, and FT4 were collected. HOMA-IR and fasting glucose-insulin ratio (FGIR) were calculated for insulin resistance. Cutoff for high CIMT was derived using ROC curve analysis. RESULTS: Overweight and obese children had higher mean CIMT than normal BMI children (0.5 ± 0.1 mm vs 0.34 ± 0.05 mm, respectively, P < 0.001). ROC analysis revealed 0.45 mm as the cutoff for high CIMT. Among overweight and obese children, 31 children (62%) had high CIMT. Among metabolic risk factors for increased CIMT, only FGIR was observed to be significant. Compared to overweight and obese children with normal CIMT, those with higher CIMT had low FGIR value (5.2 ± 2.2 mm vs 6.9 ± 2.6 mm, respectively, P < 0.05). CONCLUSION: Overweight and obese children had significantly higher CIMT than controls. Even among overweight and obese children, those with increased CIMT had low FGIR (implying insulin resistance) compared to those with normal CIMT.

A case of treatment-induced neuropathy in an adolescent with type 1 diabetes.

Treatment-induced neuropathy (TIN) in diabetes is an acute and painful yet completely reversible small fiber neuropathy precipitated by a rapid improvement in glycemic control. TIN is rare in children. A 16-year-old girl developed symmetrical painful neuropathy of the foot, autonomic neuropathy, and retinopathy 5 weeks after the diagnosis of type 1 diabetes. All causative workups were negative except for a drop-in hemoglobin A1c (HbA1c) from 17.4% to 7%, which fit with a diagnosis of TIN. Following symptomatic management, her neuropathy and retinopathy completely resolved in 2 months. Currently, she is 18 years old and doing well (HbA1c, 7.4%) without any recurrence of TIN. TIN should be suspected in any child presenting with recent-onset type 1 diabetes and acute onset neuropathy. Our case represents an unreported scenario of the rapid progression in TIN. Awareness among clinicians about this rare but completely reversible condition is necessary to ensure proper management and adherence to glycemic control.

Immunogenicity and safety of a liquid Pentavalent (DTwP-Hb-Hib) combination vaccine manufactured by Human Biologicals Institute in 6-8 weeks old healthy infants: A phase III, randomized, single blind, non-inferiority study.

BACKGROUND: A liquid Pentavalent (DTwP-Hb-Hib) combination vaccine, developed by Human Biologicals Institute, underwent a Phase III clinical study in India. In this randomized, single blind, non-inferiority study, the immunogenicity and safety of this Investigational vaccine was compared with Pentavac SD® vaccine in 6-8 weeks old healthy infants. METHODS: A total of 405 healthy infants aged 6-8 weeks old were randomized in 2:1 ratio to receive three doses of either the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine or Pentavac SD® vaccine at four to six weeks interval. Immunogenicity was compared by estimation of antibody titers before the first dose and 4-6 weeks after the third dose of vaccination. Safety of each vaccine was assessed and compared by collection of data on solicited and unsolicited adverse events throughout the study period. RESULTS: Out of a total of 405 enrolled subjects, 387 subjects completed the study. The seroconversion rates, seroprotection rates and geometric mean titres of the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine group were found to be comparable and non-inferior to the Pentavac SD® vaccine group at 4-6 weeks after the third dose of vaccination. Pain, erythema and swelling at the site of injection were found to be the most common local adverse events whereas fever, irritability and unusual crying were found to be the most common systemic adverse events in both the vaccine groups. No vaccine related serious adverse event was reported. In this study, both the Investigational vaccine as well as the Comparator vaccine were found to be immunogenic and well tolerated. CONCLUSION: After assessment of the results of the study it was concluded that the Investigational liquid Pentavalent (DTwP-Hb-Hib) combination vaccine developed by Human Biologicals Institute was immunogenic and safe when administered to infants aged 6-8 weeks and was non-inferior in immunogenicity and safety to Pentavac SD® vaccine. Clinical Trial Registry of India Identifier: CTRI/2016/01/006541.

EEG for children with complex febrile seizures.

BACKGROUND: Febrile seizures can be classified as simple or complex. Complex febrile seizures are associated with fever that lasts longer than 15 minutes, occur more than once within 24 hours, and are confined to one side of the child's body. It is common in some countries for doctors to recommend an electroencephalograph (EEG) for children with complex febrile seizures. A limited evidence base is available to support the use of EEG and its timing after complex febrile seizures among children. OBJECTIVES: To assess the use of EEG and its timing after complex febrile seizures in children younger than five years of age. SEARCH METHODS: For the latest update of this review, we searched the Cochrane Epilepsy Group Specialized Register (23 January 2017), the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Register of Studies Online (CRSO, 23 January 2017), MEDLINE (Ovid, 23 January 2017), and ClinicalTrials.gov (23 January 2017). We applied no language restrictions. SELECTION CRITERIA: All randomised controlled trials (RCTs) that examined the utility of an EEG and its timing after complex febrile seizures in children. DATA COLLECTION AND ANALYSIS: The review authors selected and retrieved the articles and independently assessed which articles should be included. Any disagreements were resolved by discussion and by consultation with the Cochrane Epilepsy Group. We applied standard methodological procedures expected by Cochrane. MAIN RESULTS: Of 41 potentially eligible studies, no RCTs met the inclusion criteria. AUTHORS' CONCLUSIONS: We found no RCTs as evidence to support or refute the use of EEG and its timing after complex febrile seizures among children. An RCT can be planned in such a way that participants are randomly assigned to the EEG group and to the non-EEG group with sufficient sample size. Since the last version of this review, we have found no new studies.

EEG for children with complex febrile seizures.

BACKGROUND: This is an updated version of original Cochrane review published in Issue 1, 2014.Febrile seizures can be classified as simple or complex. Complex febrile seizures are associated with fever that lasts longer than 15 minutes, occur more than once within 24 hours and are confined to one side of the child's body. It is common in some countries for doctors to recommend an electroencephalograph (EEG) for children with complex febrile seizures. A limited evidence base is available to support the use of EEG and its timing after complex febrile seizures among children. OBJECTIVES: To assess the use of EEG and its timing after complex febrile seizures in children younger than five years of age. SEARCH METHODS: For the latest update of this review, we searched the Cochrane Epilepsy Group Specialized Register (6 July 2015), the Cochrane Central Register of Controlled Trials (CENTRAL, 2005, Issue 6), MEDLINE (6 July 2015) and ClinicalTrials.gov (6 July 2015). We applied no language restrictions. SELECTION CRITERIA: All randomised controlled trials (RCTs) that examined the utility of an EEG and its timing after complex febrile seizures in children. DATA COLLECTION AND ANALYSIS: Review authors selected and retrieved the articles and independently assessed which articles should be included. We resolved disagreements by discussion and by consultation with the Cochrane Epilepsy Group. We applied standard methodological procedures expected by Cochrane. MAIN RESULTS: Of 37 potentially eligible studies, no RCTs met the inclusion criteria. AUTHORS' CONCLUSIONS: We found no RCTs as evidence to support or refute the use of EEG and its timing after complex febrile seizures among children. An RCT can be planned in such a way that participants are randomly assigned to the EEG group and to the non-EEG group with sufficient sample size. Since the last version of this review, we found no new studies.

Vitamin B12 deficiency presenting as pancytopenia and retinopathy in a young boy-Helicobacter pylori, a novel causative agent.

Deficiency of vitamin B12 (cobalamin) is a well-known cause of megaloblastic anaemia. It is a reversible cause of bone marrow failure and demyelinating nervous system disorder, hence early detection and prompt treatment of vitamin B12 deficiency is essential. After diagnosing vitamin B12 deficiency, tracking down its root cause is important in individualising the treatment approach. Helicobacter pylorirelated (H. pylori) B12 deficiency presenting as pancytopenia in pediatric age groups has been reported. However, vitamin B12 deficiency presenting as retinopathy in paediatric age groups has been rarely reported in the medical literature. We herein present the case of an adolescent male with pancytopenia and retinopathy, secondary to vitamin B12 deficiency-associated H. pylori infection.

EEG for children with complex febrile seizures.

BACKGROUND: Febrile seizures can be classified as simple or complex. Complex febrile seizures are associated with fever that lasts longer than 15 minutes, occur more than once within 24 hours and are confined to one side of the child's body. It is common in some countries for doctors to recommend an electroencephalograph (EEG) for children with complex febrile seizures. A limited evidence base is available to support the use of EEG and its timing after complex febrile seizures among children. OBJECTIVES: To assess the use of EEG and its timing after complex febrile seizures in children younger than five years of age. SEARCH METHODS: We searched the Cochrane Epilepsy Group Specialised Register (17 October 2013), the Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library, Issue 9, 2013), MEDLINE (17 October 2013) and the Clinical Trial Registry (ClinicalTrials.gov (17 October 2013)). We applied no language restrictions. SELECTION CRITERIA: All randomised controlled trials (RCTs) that examined the utility of an EEG and its timing after complex febrile seizures in children. DATA COLLECTION AND ANALYSIS: Review authors selected and retrieved the articles and independently assessed which articles should be included. Disagreements were resolved by discussion and by consultation with the Cochrane Epilepsy Group. We applied standard methodological procedures expected by The Cochrane Colloboration. MAIN RESULTS: Of 33 potentially eligible studies, no RCTs met the inclusion criteria. AUTHORS' CONCLUSIONS: We found no RCTs as evidence to support or refute the use of EEG and its timing after complex febrile seizures among children. A randomised controlled trial can be planned in such a way that participants are randomly assigned to the EEG group and to the non-EEG group with sufficient sample size.