Bubble CPAP - A primary respiratory support for respiratory distress syndrome in newborns.

In preterm infants with respiratory distress syndrome (RDS), the application of continuous positive airway pressure (CPAP) is associated with benefits in terms of reduced respiratory failure and reduced mortality. We conducted this prospective study to evaluate the effectiveness of bubble-CPAP as primary mode of respiratory support. Bubble CPAP was found to be safe and effective means of treating mild and moderate grade RDS, it was also observed to be more successful in babies born to mothers who had received antenatal steroids.

Immunogenicity and safety of Abhay M and M-vac vaccines in healthy infants: a phase III multicentric randomized single blind trial.

OBJECTIVE: To study immunogenicity and safety of Abhay M and M-Vac vaccines in prevention of measles in healthy infants. METHODS: In a randomized, single blind, comparative, multi-centric phase III trial, a total of 600 healthy infants between 9 - 15 months of age were recruited in the study from seven participating sites during five months. The block randomization design was used for randomizing the subjects into 2 vaccine groups (Investigational Vaccine - Abhay M and Control Vaccine - M-Vac) in the ratio 2:1. At base line (visit 1) a venous blood sample 1.5 ml was collected and subjects were then administered a single dose 0.5 ml of measles vaccine (Abhay M or M-Vac vaccine) subcutaneously according to randomization. Following administration of vaccine, subjects were observed closely for 30 - 60 minutes at the study hospitals for local reactions and systemic events. At visit 2 (follow up visit) another venous blood sample 1.5 ml was collected and the paired sera (both pre and post vaccination serum) were tested concurrently. Safety and immunogenicity were assessed through follow-up of adverse events and anti measles antibody response respectively. RESULTS: Overall 95.7 % seroconversion was achieved in both the groups, 96% in Abhay M vaccine group and 95.1%. in M-Vac vaccine group. There were no statistically significant differences in the observed seroconversion rates. In Abhay M vaccine group, the pre vaccination geometric mean titers (GMT) significantly increased from 35.5 mIU/ml to 486.9 mIU/ml after vaccination. The observed significant increase of GMT in M-Vac vaccine group was from 33.3 mIU/ml to 375.8 mIU/ml. Overall 459 (82.5%) out of 556 subjects were seroprotected after vaccination i.e. > or equal to [corrected] 200 mIU/ml (Protective levels). Of the 459 seroprotected, 315 (84.9%) subjects were in Abhay M vaccine group and 144 (77.8%) subjects were in M-Vac vaccine group. The frequencies of the reported local and general symptoms were similar between the Abhay M vaccine group and M-Vac vaccine group. CONCLUSION: Human Biologicals Institute's Abhay M vaccine is equally immunogenic and as safe as M-Vac vaccine when administered to healthy infants in single dose schedule.

Immunogenicity and safety of combined diphtheria tetanus whole cell pertussis hepatitis B/ Haemophilus influenzae type b vaccine in Indian infants.

OBJECTIVE: To evaluate the immunogenicity of the Hepatitis B and Haemophilus influenzae type b components and the overall safety and reactogenicity of the DTPw-HBV/Hib vaccine when given as primary vaccination to Indian infants. DESIGN AND METHODS: At 3 centers in India, 225 healthy infants (who had received HBV at birth) received three doses of DTPw-HBV/Hib vaccine at 6, 10 and 14 weeks of age. Serum anti-HBs and anti-PRP antibody levels were measured prior to vaccination and one month post dose 3. Solicited local and general symptoms reported during the 4-day follow-up period and unsolicited adverse event reported during the 30-day follow-up period after each dose were recorded. Serious adverse events were recorded throughout the study. RESULTS: A total of 219 subjects completed the study. 2.7% and 11.5% of all administered doses led to redness and swelling >20 mm, respectively; only 3.6% of doses were followed by severe pain (cried when limb was moved, spontaneously painful) within 4 days after vaccination. Fever exceeding 39.5C was recorded following only one dose in one subject. The percentage of doses followed by severe solicited general symptoms (symptoms that prevented normal activity) did not exceed 0.8%. Two SAEs were reported, neither of which were considered as related to vaccination. One month post-dose 3, all subjects had seroprotective antiPRP antibody concentrations (> or =0.15 microgram/mL) and 98.6% had concentrations > or =1 microgram/mL; 99% were seropositive for antiHBs (concentrations > or = 3 mIU/mL) and 99% were seroprotected (concentrations > or = 10 mIU/mL). CONCLUSION: The combination DTPw-HBV/Hib vaccine is immunogenic (for the antigens tested), safe and well tolerated in Indian infants.

Appendicitis with perforartion in a neonate.

Appendicitis is a very rare clinical entity in neonates. Preterm and male neonates are commonly affected. It is often seen in association with surgical conditions like Hirschsprung's disease and necrotizing enterocolitis. Non-specific clinical features result in delay in the diagnosis and predisposes to perforation. The risk of perforation is very high (85%) in neonatal appendicitis. Management includes pre-operative stabilization, appendicectomy and peritoneal drainage in cases of perforation with peritonitis. Prognosis is uniformly poor with mortality rate as high as 70%. Herewith reporting a neonate with multiple perforations who was successfully managed.

Accidental dextropropoxyphene poisoning.

Dextropropoxyphene poisoning is an uncommon accidental poisoning in children. Presentation is similar to narcotic over dosage or poisoning. Convulsions, conduction disturbances, arrhythmias and hypoglycemia are common. Naloxone is the antidote. As it is uncommon and not documented in children in Indian literature we are reporting this case.

Role of score for neonatal acute physiology (SNAP) in predicting neonatal mortality.

OBJECTIVES: To assess the validity of SNAP in predicting the outcome in terms of mortality and duration of hospital stay. The study was also undertaken to evolve the best cut-off SNAP scores for predicting mortality in different individual neonatal conditions. METHODS: 295 consecutive newborn admitted to NICU during an eleven month period were evaluated with the investigations required as per the specifications of SNAP. Neonates who succumbed within 24 hours of admission and those who were shifted to the NICU for observation purposes were excluded. RESULTS: In general, SNAP correlated well with mortality; the sensitivity and specificity of SNAP score > 15 in predicting mortality were 63% and 95% respectively. The positive and negative predictive values were 72% and 92.5% respectively. Very low birth weight babies and ventilated preterm neonates had higher mortality and the best cut-off SNAP score for predicting mortality in these groups was 10. In all the other groups, SNAP score > 15 correlated well with higher mortality. By using multiple regression analysis on three variables including birth weight, gestational age and SNAP, SNAP was found to show the best correlation with mortality. On correlating SNAP with duration of hospital stay, 76.8% of the surviving neonates with SNAP < 16 stayed for < 15 days, whereas the rest stayed longer despite low SNAP. All the 9 babies with SNAP > 15 who survived stayed for > 15 days. CONCLUSIONS: SNAP is a measure of illness severity and correlates well with neonatal mortality. SNAP may assist the clinician in explaining the probable outcome and therapeutic intervention needed and the cost of treatment to the parents. SNAP scores > 10 in VLBW babies and > 15 in others are associated with higher mortality.

Multicenter randomized placebo controlled trial of therapy with intravenous immunoglobulin in decreasing mortality due to neonatal sepsis.

OBJECTIVE: To determine whether therapy with intravenous immunoglobulin G (IVIG) would decrease mortality in neonatal sepsis. SETTING: Three tertiary care neonatal intensive care units in the city of Bangalore. METHODS: All neonates admitted to the Neonatal Intensive Care Units with the clinical diagnosis of sepsis and having at least C-reactive protein and one other rapid diagnostic criteria positive were enrolled. Neonates with a birth weight of less than 1000 g and those with any major congenital malformation were excluded. The neonates were randomized to receive 1 g/kg of IVIG on three consecutive days or an equivalent amount of placebo. The rest of the treatment including antibiotics and supportive care was as per the treating physician's decision. The main outcome variable was survival. RESULTS: The trial was carried out over a period of 8 months and recruited 58 neonates. Seven neonates who qualified but did not receive either IVIG or placebo were taken into a separate control group, and one baby who received only one dose of IVIG was excluded from the analysis. Twenty-five neonates were enrolled into the IVIG arm and 25 in the placebo arm. The neonates in the therapy and placebo groups were comparable in terms of birth weight (2144+/-675 g vs. 2072+/-682 g), gestation (37.0+/-3.56 vs. 35.8+/-3.52 weeks), sex distribution, duration of stay, and number requiring ventilation. The placebo group had a significantly higher number of babies with positive blood culture. Seven babies in each group died (p>0.05). There was no significant benefit in using IVIG (OR 1.0; 95% CI 0.25-4.07) (p = 0.74). CONCLUSION: In the sample studied therapy with IVIG did not reduce mortality in neonatal sepsis

Clinical profile and management of PDA in neonates.

Patent ductus arteriosus (PDA) is recognised more often with increasing survival of preterm babies. The pharmacological closure of ductus by indomethacin has changed the management of PDA. Twenty neonates admitted over a period of 21 months to Neonatal Intensive Care Unit (NICU) of M.S. Ramaiah Medical College hospital, Bangalore, who were diagnosed to have PDA, were analyzed. The objectives of this retrospective analysis were to study the clinical profile, the efficacy of oral indomethacin and the outcome of PDA. 2-D and Doppler echocardiaography were used to confirm the clinically suspected PDA. These neonates were treated with 3 doses of oral indomethacin (0.2-0.25 mg/kg/dose 12 hourly) along with fluid restriction and oxygen. Echocardiography was repeated to demonstrate the closure of PDA. The incidence of PDA was 2.3% of total NICU admissions. Seventy percent of this cohort were < 32 weeks of gestation, 55% had birth weight of < 1500 gms. Seventy percent (14) neonates had onset of PDA after 48 hrs of life. 81.25% of neonates responded to indomethacin and overall survival rate in treated group was 67%. Drug related complications were noted in 2 newborns. This study illustrates the utility of echocardiography in diagnosing and monitoring PDA in preterm and low birth weight babies with high index of suspicion of this common congenital heart disease. Pharmacological intervention with indomethacin is rewarding with acceptable results.

Mechanical ventilation of newborns: experience from a level II NICU.

OBJECTIVES: To analyse the indications, clinical profile, complications and outcome of the babies requiring mechanical ventilation. DESIGN: Retrospective study. SETTING: NICU of a teaching hospital. SUBJECTS: One hundred and twenty one neonates requiring assisted ventilation during three years. RESULTS: Of 121 babies 59(48.76%) survived. Hyaline membrane disease (HMD) was the commonest indication for ventilation followed by birth asphyxia, apnea of prematurity, meconium aspiration syndrome (MAS) and septicemia. Infants with HMD whose birth weight was more than 1.5 kg and those who required ventilation after 24 hours of birth had better outcome. Survival rates increased with increasing birth weight and gestational age. Prolonged ventilatory support was needed for HMD (mean 117.3 hr) and MAS (mean 82.6 hr). Pneumonia was the commonest complication, followed by sepsis, air leak syndromes and intracranial and pulmonary hemorrhage. CONCLUSIONS: Ventilatory facilities must be focussed for neonates weighing > 1000 g. Assisted ventilation may not be cost-effective in patients weighing < or = 1000 g and those with complex heart diseases and other congenital anomalies.