A phase III randomized-controlled study of safety and immunogenicity of DTwP-HepB-IPV-Hib vaccine (HEXASIIL®) in infants.

A fully liquid hexavalent containing Diphtheria (D), Tetanus (T) toxoids, whole cell Pertussis (wP), Hepatitis B (Hep B), type 1, 2, 3 of inactivated poliovirus (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (DTwP-HepB-IPV-Hib vaccine, HEXASIIL®) was tested for lot-to-lot consistency and non-inferiority against licensed DTwP-HepB-Hib + IPV in an open label, randomized Phase II/III study. In Phase III part, healthy infants received DTwP-HepB-IPV-Hib or DTwP-HepB-Hib + IPV vaccines at 6, 10 and 14 weeks of age. Blood samples were collected prior to the first dose and 28 days, post dose 3. Non inferiority versus DTwP-HepB-Hib + IPV was demonstrated with 95% CIs for the treatment difference for seroprotection/seroconversion rates. For DTwP-HepB-IPV-Hib lots, limits of 95% CI for post-vaccination geometric mean concentration ratios were within equivalence limits (0.5 and 2). Vaccine was well-tolerated and no safety concerns observed.Clinical Trial Registration - CTRI/2019/11/022052.

Effect of oral stimulation on feeding performance and weight gain in preterm neonates: a randomised controlled trial.

BACKGROUND: In preterm infants, oral stimulation enhances muscle tone and movement which facilitates normal oral motor developmental patterns improving oral feeding performance. AIM: To study the effects on feeding performance, transition to independent oral feeding, weight gain and length of hospital stay of an oral stimulation programme in preterm neonates. STUDY DESIGN: This randomised controlled trial was conducted in a tertiary care teaching hospital over a period of 10 months. Altogether, 102 preterm neonates (30-34 weeks gestation) were randomised into the intervention group (oro-motor stimulation for 5 min twice a day, n = 51) or the control group (routine care only, n = 51). The primary outcome measures were feeding performance, and transition period to reach independent oral feeding. RESULTS: There was better feeding performance (overall intake and rate of milk transfer), shorter transition to independent oral feeding, better weight gain and shorter length of hospital stay in the intervention group (p < 0.001). CONCLUSIONS: Oral stimulation improves feeding performance, weight gain rate and reduces hospital stay in preterm neonates born between 30 and 34 weeks of gestation. [Trial registration number: CTRI/2017/05/008630].

Transcutaneous Bilirubin Nomogram for Healthy Term and Late Preterm Neonates in First 96 Hours of Life.

BACKGROUND: To develop nomogram of Transcutaneous Bilirubin among healthy term and late-preterm neonates during first 96 hours of age. DESIGN: Longitudinal observational study. SETTING: Neonatal unit of a tertiary care Hospital of Central Gujarat, India. PARTICIPANTS: 1075 healthy term and late preterm neonates (≥35weeks). INTERVENTION: Six-hourly transcutaneous bilirubin was obtained from birth to 96 hour of life using Drager JM 103 Transcutaneous Bilirubinometer. METHODS: Main outcome measures: Nomogram of Transcutaneous Bilirubin with percentile values was obtained, rate of rise of bilirubin was calculated and predictive ability of normative data was analyzed for subsequent need of phototherapy. RESULTS: The age-specific percentile curves and nomogram were developed from the transcutaneous bilirubin readings of 1,010 neonates. Rate of rise in first 12 hour was 0.2 mg/dL and was 0.17 mg/dL in 12 to 24 hour of life which decreased on second day of life. Neonates who required phototherapy had consistently higher readings of transcutaneous bilirubin and also higher rate of rise in first 48 hrs. CONCLUSION: Neonates whose transcutaneous bilirubin is above the 50th percentile should be monitored for the development of significant hyperbilirubinemia.

Dyke-Davidoff-Masson syndrome: A rare cause of cerebral hemiatrophy in children.

Dyke-Davidoff-Masson syndrome (DDMS) is an uncommon condition, in which the diagnosis is mainly done by various clinical presentations along with positive radiological findings. Patients have facial asymmetry, seizures, learning difficulties, and contralateral hemiparesis. The radiological discoveries of the same incorporate cerebral hemiatrophy with homolateral hypertrophy of the skull and sinuses. Here, we report a case of a 10-year-old female child who presented with a single episode of convulsion, mental retardation, and contralateral hemiparesis. Magnetic resonance imaging of the brain showed unilateral atrophy of the left cerebral hemisphere with dilatation of ipsilateral lateral ventricle and ipsilateral sulcal prominence. These findings were suggestive of the diagnosis of DDMS.

Communication skills to ensure patient satisfaction.

Every pediatrician would want to satisfy their patients and their parents to sustain good practice, earn name and fame and simultaneously to avoid litigation in this era of consumer protection act. This can be achieved only by use of good communication skills. Today the patients demand time, information and want their questions to be answered. They expect politeness, empathy and human touch from doctors. Time constraints, arrogance, telephone calls, language barriers and cultural insensitivity are the important barriers to good communication. Research has shown that doctor, who undergoes training to acquire good communication skills, can better satisfy his patients. Good communication skill is an art which can be acquired or improved by putting conscious efforts in day to day practice. Such skills should also be incorporated as part of medical teaching curriculum. Asking open ended questions, effective listening, appropriate praise, providing enough information as part of advice and finally checking their understanding, are the key areas of communication during medical interview. During this process pediatrician should ensure to address the parental concerns, should empathize with parents and involve parents in decision making. This will not only ensure satisfaction of parents but also their adherence to the therapy and to the pediatrician.