A phase III randomized, controlled study to assess and compare the immunogenicity and tolerability of single and multi-dose vials of DTwP-Hib, a fully liquid quadravalent vaccine and their comparison with TETRAct-Hib vaccine in Indian infants aged 6-14 weeks.

Both WHO and IAP encourage using combination vaccines, wherever feasible. The phase III trial reported here was conducted to assess and compare the immunogenicity, tolerability and safety of two quadravalent vaccines, Quadrovax(®) (new vaccine), and TETRAct-Hib(®) (available in the market) in a multicentre study, in India. In all, 361 infants aged 6-8 weeks were enrolled, out of which 339 completed the study. The vaccination was done at 6-10-14 weeks following EPI/WHO recommended immunization schedule. Blood samples were collected prior to the administration of first dose and one month after the third dose. Postvaccination, geometric mean titres for each component did not differ significantly between the single dose vial and multi dose vial subgroups and among the two study groups. Adverse events observed were within the range quoted in literature. Quadrovax(®) vaccine manufactured by SIIL was found to be safe, immunogenic and non-inferior to the comparator vaccine. The quadravalent vaccine is best recommended in the second year of life when children receive their booster dose at 15-18 months. It can be given to infants during primary immunization series at 6, 10 and 14 weeks of age when Hepatitis B vaccine is given in a separate arm or to infants at 10 weeks who receive the Hepatitis B vaccine separately following the 0, 6 and 14 weeks or 0, 1 and 6 months schedule.

Refractory seizures with global developmental delay: A rare cause.

Aicardi syndrome is a genetic disorder characterized by the triad of infantile spasm in flexion, callosal agenesis and ocular abnormalities (chorioretinal lacunae, coloboma of optic disc). We report a typical case of Aicardi syndrome with all the classical features.

Clinical, laboratory and radiological parameters in children with dengue fever and predictive factors for dengue shock syndrome.

This article is a prospective study of the clinical, laboratory and radiological picture of children satisfying the case definition criteria of dengue by WHO admitted at Sri Ramachandra Medical College and Research Institute, a suburban tertiary referral centre, to determine the predictive factors for dengue shock syndrome (DSS). Data were analyzed by Chi-squared test and Student's t-test for significance after dividing the patients into two groups, those with and those without DSS for the same. Bleeding manifestations, presence of effusion on USG/X-ray, haematocrit >35%, WBC <4000/cumm, Na < or =130 meq/l, bicarbonate level of <18 mmol/l, deranged coagulation profile and serum glutamic pyruvic transaminase (SGPT) > or =40 IU were predictive of DSS.

Prevalence of Helicobacter pylori infection in children with recurrent abdominal pain.

The present study was performed to study the prevalence of Helicobacter pylori (H. pylori) infection in children with recurrent abdominal pain (RAP). Children above 3 years of age of both sexes attending the OPD of a teaching hospital, with complaints of at least three discrete episodes of abdominal pain of sufficient severity to interrupt normal daily activities, occurring over a period of one month or more and with out identifiable cause of pain were enrolled in the study. The subjects were divided into 3 age groups of 3-5 years, 5-8 years and 8-12 years. Thirty normal controls from each age group were also enrolled. Detailed history was taken and thorough physical examination was done. Estimation of haemoglobin and specific IgG antibodies to H. pylori by Immunocomb II was done. Upper gastrointestinal endoscopy was performed with a fibreoptic pediatric sized endoscope in RAP cases after obtaining informed parental consent. Multiple biopsy samples were taken and subjected to Rapid Urease Test (RUT), Gram's Staining, Culture and histology. Data obtained were analyzed, using Fisher's Z Test, Students t-test or Chi Square as applicable. Sixty-eight cases and 90 controls were enrolled, the number in various age groups being comparable (p >0.05). Seropositivity rate was significantly more in cases (60.3%) compared to controls (10%) (p <0.001) even among various age groups (<0.01). Prevalence increased with advancing age from 3.3% to 16.7% in controls, but not among cases. Seropositivity rates among males and females were comparable both among cases and controls. Incidence of malnutrition, stunting and anemia were similar irrespective of serological status. Total duration of illness, frequency, duration of each episode, and location of pain were also comparable. Among 10 seropositive children who underwent upper gastrointestinal endoscopy 80% showed one or more abnormalities, while the single seronegative child had no abnormal finding. Half the seropositive cases had gastritis, hyperemia or erosion on gross examination. Histopathological evidence of gastritis was present in 40%, but culture was negative in all. There is a significant association of H. pylori infection and RAP. But studies involving larger number of children undergoing endoscopy is required for definite evidence of a 'cause and effect'.

Early onset neonatal sepsis.

OBJECTIVE: To study the maternal risk factors and clinico-bacteriological profile of early onset sepsis (EOS), in a tertiary care neonatal unit. METHODS: Relevant data of neonates born during the study period were obtained from their case records. A diagnosis of early onset sepsis was made if either clinical sepsis developed within 72 hours of life or if positive blood/CSF cultures were obtained in those with potential maternal risk factors. Statistical analysis was done using Odds Ratio or Chi-square and Fisher's exact t-test as applicable. RESULTS: Among 1743 live births, a total of 69 episodes of sepsis occurred in 65 neonates (43% culture proven) with an incidence of 37.2 per 1000 live births. The incidence of EOS was 20.7 per 1000 live births and it constituted 55.4% of overall sepsis. Among the perinatal risk factors assessed, a significant association of EOS with prolonged rupture of membranes, foul smelling liquor, dai (midwife) handling and maternal urinary tract infection was observed (p < 0.05). Among infants at risk of EOS, 20.6% developed sepsis compared to only 0.5% of those without these risk factors (p 0.001). Even among those at high risk such as low birth weight, preterm, and asphyxiated neonates, incidence of EOS was negligible in the absence of a maternal risk factor. Pneumonia (66.7%), shock (27.7%), metabolic acidosis (19.4%) and meningitis (8.3%) were the comorbidities seen among the cases. Culture proven EOS occurred in 41.6%, Pseudomonas being the commonest (60%) isolate. The case fatality rate was 19.4%. CONCLUSION: Screening for sepsis in an asymptomatic neonate is warranted only in the presence of a maternal risk factor even if the neonate is at high risk of developing sepsis due to associated problems of prematurity, low birth weight or asphyxia. Knowledge of likely causative organisms of EOS can aid in instituting prompt and appropriate therapy, in order to minimise morbidity and mortality.

A case of TRAP sequence: acardiac twin.

Monochorionic twinning contributes significantly to neonatal morbidity and mortality. The twin-twin transfusion syndrome complicates 5-35% of monozygotic twin pregnancies with monochorionic placentation. The most severe and a rare manifestation of this condition is acardiac twinning which is seen in 1 in 35,000 pregnancies. The acronym TRAP (Twin Reversed Arterial Perfusion) sequence is used to describe this condition. The acardiac twin does not survive while the mortality for the normal twin is about 50%. Proper timing of the delivery is of prime importance to survival of the normal fetus for which emphasis is placed on close sonographic monitoring for early antenatal diagnosis. We present such a case of TRAP sequence because of its rarity.