Safety and immunogenicity of a live oral recombinant cholera vaccine VA1.4: a randomized, placebo controlled trial in healthy adults in a cholera endemic area in Kolkata, India.

Background: A live oral cholera vaccine VA 1.4 developed from a non-toxigenic Vibrio cholerae O1 El Tor strain using ctxB gene insertion was further developed into a clinical product following cGMP and was evaluated in a double-blind randomized placebo controlled parallel group two arm trial with allocation ratio of 1∶1 for safety and immunogenicity in men and women aged 18-60 years from Kolkata, India.

Method: A lyophilized dose of 1.

Effectiveness of zinc supplementation plus oral rehydration salts for diarrhoea in infants aged less than 6 months in Haryana state, India.

Objective: To determine if educating caregivers in providing zinc supplements to infants < 6 months old with acute diarrhoea is effective in treating diarrhoea and preventing acute lower respiratory infections (ALRIs), and whether it leads to a decrease in the use of oral rehydration salts (ORS).

Methods: In this retrospective subgroup analysis of infants aged < 6 months, six clusters were randomly assigned to intervention or control sites. Care providers were trained to give zinc and ORS to children with acute diarrhoea at intervention sites, and only ORS at control sites.

Prediction equations for body-fat percentage in Indian infants and young children using skinfold thickness and mid-arm circumference.

The objective of the study was to develop prediction equations for fat-mass percentage in infants in India based on skinfold thickness, mid-arm circumference, and age. Skinfold thicknesses and mid-arm circumference of 46 apparently-healthy infants (27 girls and 19 boys), aged 6-24 months, from among the urban poor attending a well baby clinic of a hospital in Kolkata were measured. Their body-fat percentage was measured using the D2O dilution technique as the reference method.

Total body water and fat-free mass: evaluation of equations based on bioelectrical impedance analysis in infants and young children in India.

The association of early postnatal growth with diseases in adults such as hypertension, type 2 diabetes and CHD has generated interest in studying postnatal growth. Bioelectrical impedance analysis (BIA) is a useful measure to estimate total body water (TBW) and fat-free mass (FFM). We evaluated three published equations (Fjeld et al.

Receiver operating characteristics (ROC) curve estimation of low birth weight based on maternal early third trimester weight among Bengalee women of Kolkata, India.

The cross-sectional hospital based study was undertaken to provide an efficient and useful cut off point of maternal early third trimester weight, for low birth weight (LBW), based on receiver operating characteristics (ROC) curve among Bengalee mothers of Kolkata, India. A total of 233 mother-baby pairs were included in the present analysis. The means for maternal age and weight were 23.

Purification and characterization of an immunogenic outer membrane protein of Shigella flexneri 2a.

In the present study we purified 34 kDa major outer membrane protein (MOMP) of Shigella flexneri 2a for the first time, which was cross-reactive and antigenically conserved among Shigella spp. and the epitope was surface exposed on the intact bacterium. The purified antigen was found to be glycosylated, which aids in binding to macrophages and up-regulated the production of nitric oxide, granulocyte-colony stimulating factor and IL-12p70, indicating that the MOMP is immunogenic and has the ability to commence protective immune responses against intracellular pathogens, thereby it may be considered as a potential vaccine candidate.

Effect of zinc supplementation on morbidity and growth in hospital-born, low-birth-weight infants.

Background: Low-birth-weight infants may have impaired zinc status, but little is known about the effect of zinc supplementation.

Objective: The objective was to investigate the effect of daily zinc supplementation on morbidity and anthropometric status in hospital-born, low-birth-weight infants.

Design: In a double-blind, randomized, placebo-controlled trial, 2052 hospital-born term infants with a birth weight < or =2500 g were randomly assigned to receive zinc or placebo.

Randomized placebo controlled human volunteer trial of a live oral cholera vaccine VA1.3 for safety and immune response.

A live oral cholera vaccine developed from a non-toxigenic Vibrio cholerae O1 El Tor strain VA1.3 was tested in a double-blind randomized placebo controlled study for safety and immunogenicity in 304 men aged between 16 and 50 years from Kolkata, India. A dose of 5 x 10(9)CFU (n=186) or a placebo (n=116) containing the diluent buffer was administered.

Directing diarrhoeal disease research towards disease-burden reduction.

Despite gains in controlling mortality relating to diarrhoeal disease, the burden of disease remains unacceptably high. To refocus health research to target disease-burden reduction as the goal of research in child health, the Child Health and Nutrition Research Initiative developed a systematic strategy to rank health research options. This priority-setting exercise included listing of 46 competitive research options in diarrhoeal disease and their critical and quantitative appraisal by 10 experts based on five criteria for research that reflect the ability of the research to be translated into interventions and achieved disease-burden reduction.

Impact of a district level sick newborn care unit on neonatal mortality rate: 2-year follow-up.

Objective: To evaluate the impact of creating a sick newborn care unit (SNCU) in a district hospital on neonatal mortality rate (NMR).

Study Design: This study was conducted in a district hospital with 6500 deliveries a year. A 14 bed SNCU that included controlled environment, individual warming and monitoring devices, infusion pump, central oxygen and oxygen concentrators, resuscitation and exchange transfusion, portable X-ray and in-house laboratory was created.

Evaluation of equations for fat-free mass based on anthropometry in infants and young children in South Asia.

Rapid postnatal growth in low-birth weight infants increases the risk of hypertension, CHD and type 2 diabetes in adult life. To provide validated tools to study the growth in South Asian infants, we evaluated two published equations to measure total body water (TBW) and fat-free mass (FFM) based on anthropometry in 6- to 24-month-old infants, using 2H2O dilution. In a method-comparison study in seventy-eight infants aged 6-24 months (forty-two girls and thirty-six boys) from the urban poor attending an immunisation clinic of a hospital in Kolkata, we measured their length to the nearest 0.

A randomized, placebo-controlled trial of the bivalent killed, whole-cell, oral cholera vaccine in adults and children in a cholera endemic area in Kolkata, India.

Objectives: An effective vaccine against cholera has been used for public health purposes in Vietnam since the 1990s. This vaccine was reformulated to meet WHO requirements. We assessed the safety and immunogenicity of the reformulated bivalent (Vibrio cholerae 01 and 0139) killed whole cell oral vaccine in a cholera endemic area in Kolkata, India.

Effectiveness of zinc supplementation plus oral rehydration salts compared with oral rehydration salts alone as a treatment for acute diarrhea in a primary care setting: a cluster randomized trial.

Objective: The purpose of this work was to evaluate whether education about zinc supplements and provision of zinc supplements to caregivers is effective in the treatment of acute diarrhea and whether this strategy adversely affects the use of oral rehydration salts.

Patients And Methods: Six clusters of 30,000 people each in Haryana, India, were randomly assigned to intervention and control sites. Government and private providers and village health workers were trained to prescribe zinc and oral rehydration salts for use in diarrheal episodes in 1-month-old to 5-year-old children in intervention communities; in the control sites, oral rehydration salts alone was promoted.

Newborn Aides: an innovative approach in sick newborn care at a district-level special care unit.

A Sick Newborn Care Unit (SNCU), established in a district hospital in India, substantially reduced the neonatal mortality rate in the district; it, however, suffered from a dearth of trained nurses. Local girls with 10-12 years of school education underwent structured and hands-on training for six months, followed by a six-month internship at the SNCU and were assigned to it as stipendiary 'Newborn Aides'. Based on the results of formal examinations, internal on-the-job assessment and interview of doctors, nurses, and parents and their technical skills and motivation were rated very high.

Maternal early second trimester pregnancy weight in relation to birth outcome among Bengalee Hindus of Kolkata, India.

Objective: The study examined to what degree maternal early second trimester pregnancy weight is useful and efficient in predicting birth outcome of Bengalee women.

Subjects And Methods: The cross-sectional retrospective study was conducted in a government general hospital in South Kolkata, India. This hospital serves the needs of people belonging to lower and lower middle class socio-economic groups.

Genu recurvatum in hemophilia: a case report.

Hemorrhages in the musculoskeletal system of patients with hemophilia give rise to a number of disabilities requiring rehabilitative measures. The knee is the most commonly affected joint. Recurrent hemorrhages in the knee joint can cause arthropathy and flexion deformity.

Study of hand function in a group of shoe factory workers engaged in repetitive work.

Background: Work related hand and wrist musculoskeletal disorders are well known. The contributing factors could be repetitive movements, forceful work and awkward posture. It is not known how these movements affect grip or pinch strength and other functional aspects of the hand.

Role of Shigella flexneri 2a 34 kDa outer membrane protein in induction of protective immune response.

Emergence of Shigella vaccine is in great need in developing countries. In this paper we have shown that 34 kDa Shigella flexneri 2a outer membrane protein has a role in eliciting immune responses. When injected parentarally this protein gives significant protection against challenge with virulent Shigella flexneri 2a.

Antioxidant vitamins E and C as adjunct therapy of severe acute lower-respiratory infection in infants and young children: a randomized controlled trial.

Objective: To evaluate the effect of antioxidant Vitamins E and C as adjunct therapy of severe acute lower respiratory infection (ALRI) in children.

Design: Randomized double-blind placebo-controlled clinical trial.

Setting: A large childrens' hospital serving the urban poor in Kolkata, India.

Haematological response to iron supplementation is reduced in children with asymptomatic Helicobacter pylori infection.

We evaluated the adverse effect of asymptomatic Helicobacter pylori infection in children on the response to Fe supplementation. One hundred and sixty-nine children aged 1-10 years from the urban poor community underwent a [13C]urea breath test for H. pylori and haematological tests at admission and after 8 weeks.

Routine use of antimicrobials by pregnant Indian women does not improve birth outcome: a randomized controlled trial.

Low birth-weight is a leading health problem in developing countries. In a randomized controlled trial, the effect of antimicrobials in pregnant women on improving birth-weight and duration of gestation was evaluated. Two hundred twenty-four pregnant women in their second trimester were randomized to receive metronidazole (200 mg 3 times daily for 7 days) and cephalexin (500 mg twice daily for 5 days) orally by one group.

A pilot test of the addition of zinc to the current case management package of diarrhea in a primary health care setting.

Zinc is recommended for the treatment of acute diarrhea in children but the effect of its introduction on drug and oral rehydration solution use is unclear. Government care providers, private practitioners and community workers were trained to distribute zinc and oral rehydration solution to children seeking care for diarrhea. Periodic surveys showed that village-based workers became a common source of diarrhea treatment and private practitioners were used less.