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Community Medicine

Surveillance of neonatal infection – An ICMR task force study

Funded Agency: ICMR
Duration of Study: 2011-15
Principal Investigator:Garg BS, Maliye CH, Mendiratta DK, Dikshit S, Deotale V
Ethics Approval:

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Concurrent Monitoring for Quality Improvement in ICDS,

Funded Agency: Govt of India (NIPCCD)
Duration of Study:
Principal Investigator: Garg BS, Subodh S Gupta, Maliye CH, Raut AV, Solanki RS, Ambilkar A, Kalantri A
Ethics Approval:

Total Grant: 1.74 Lakhs

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Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of live attenuated Bovine-Human Rotavirus Reassortant Pentavalent Vaccine (BRV-PV) against severe Rotavirus gastroenteritis in healthy Indian infants

Funded Agency: PATH/SIIL
Duration of Study: 2013- 2016
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Jain M, Bahulekar PV, Raut AV, Solanki RS
Total Grant: 814 Lakhs

Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ COMMED/16/2013 dated 8.5.2013)

A promising new rota virus vaccine candidate called ‘BRV-PV’ is being tested in a Phase 3 efficacy study in India to determine if its administration to infants can reduce the incidence of severe diarrhea due to rota virus.

Each year, approximately 600,000 children die from severe, dehydrating diarrhea worldwide. Rota virus is the most common cause of severe infantile diarrhea—accounting for approximately one-third of these child deaths. In India alone, an estimated 11.37 million episodes of rota virus gastroenteritis occur each year, with 78,000 cases resulting in death. The development of new rota virus vaccines have the potential to make an enormous impact on public health by reducing rota virus-related illness and deaths worldwide, particularly in low-resource countries.

World Health Organization (WHO) strongly recommends use of rota virus vaccine in countries where diarrhea accounts for more than 10 percent of deaths among children less than five years of age, as is the case in India. However, they are not yet widely available or affordable for most low-income communities. A key strategy for creating and maintaining a long-term, financially sustainable supply of rota virus vaccines is entry of more vaccine products - particularly those based in emerging countries - in the market.

MGIMS is one of the six sites in the phase 3 trial sponsored by Serum Institute of India Ltd. (SIIL) and PATH. The purpose of the trial is to find out whether vaccination with BRV-PV can reduce the incidence of severe diarrhea due to rota virus among children in India. MGIMS will enroll 1000 study subjects out of total 7,500 proposed enrollment for all study sites. By January 2015, Sevagram site had completed 80% of enrollments allocated to the site under this study.

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Audit of information regarding malnutrition, under-five & maternal deaths in Melghat tribal area of Maharashtra

Funded Agency: UNICEF, Mumbai
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Raut AV, Bahulekar PV, Bharambe MS, Ambilkar A, Kalantri A
Ethics Approval:

Total Grant: 9.05 Lakhs

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Centre for Advanced Research for Community Based Maternal,Newborn and Child Health (ICMR)

A. Community-owned Management Information System: an Alternative Model of Community Monitoring for Health

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

B. Central India Rural Pregnancy Cohort

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, PV Shivkumar, Gupta SS, Maliye CH, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

C. Improving health care seeking for morbidities among newborns and young infants in rural Wardha

Funded Agency:
Duration of Study:
Principal Investigator: Garg BS, Gupta SS, Maliye CH, Jain M, Bharambe MS, Bahulekar PV, Raut AV, Solanki RS, Pawar R
Ethics Approval:

Surveillance of infection in neonates (0-28 days) : A Multi-centric Task Force Study

Funding Agency: ICMR
Principal Investigator: Dr.BS. Garg, Dr. CH Malliye , Dikshit S, Deotale V
Ethics Approval: Institutional Ethics Committee, MGIMS (MGIMS/IEC/16/2010 dated 11/05/2010)

In India approx. 65% deliveries takes place at home and 30-50% neonatal deaths are due to sepsis. There are no community based studies of neonatal sepsis and limited data are available from first level health facilities and home delivered babies. Prospective microbiological surveillance is important to guide empiric therapy, identify new agents of importance to neonates. Moreover organisms associated with neonatal infection are different in different geographic area. In this background it is proposed to carry out a surveillance study to identify organisms causing sepsis and their antimicrobial susceptibility. The study is aimed at identifying organism causing sepsis in neonates in the community and their profile. In addition, the study also aimed to validate agreement between suspected sepsis, culture positive sepsis and positive sepsis screen and shall use this knowledge for capacity building at district hospital.

This is a prospective study for understanding prevalence, etiology/ causative agents and antimicrobial susceptibility patterns of organism causing sepsis in young infants(<60 days).

Because a district hospital is a referral unit for the community and primary health centers, the cases enrolled in the facilities are likely to represent the community. All newborns either delivered in the facilities or referred from periphery for admission and treatment were evaluated for symptoms and signs of probable sepsis using established criteria for diagnosis of sepsis. On enrollment detailed history was obtained on duration of symptoms, details of delivery, period of gestation, antenatal care received by the mother, problems during pregnancy, and treatment history before admission. A detailed clinical examination was done and data were collected in pre-designed structured proforma. All blood samples were collected from each newborn enrolled, for microbiological evaluation as well as for sepsis screen (absolute neutrophill count, total WBC count, Immature neutrophil ratio, C Reactive Protein) following standard methodology.

Pediatrician / medical officers of district hospital managed the neonates according to the standard protocol. All newborns were followed during hospital stay and their status at discharge was recorded. Attempts are being made to record outcome on day 28 / 1 month by the project staff.

A total of 7422 babies have been screened for sepsis and 213 babies were suspected for sepsis. Blood culture was sent to the Microbiology laboratory at Kasturba Hospital, Sevagram.

Perception of non-surgical permanent contraception

Principal Investigator: Dr BS Garg & Dr PV Shivkumar
Ethics Approval: Obtained from Institutional Ethics Committee, MGIMS (MGIMS/IEC/ COMMED/41/2013 dated 28/09/2013)

Female permanent contraception, also known as sterilization, is a highly effective contraceptive method that is widely used in both high and low resource settings. Yet it is the only method of contraception for women that requires surgery. The development of a non-surgical method of permanent contraception (NSPC) will offer women another contraceptive choice, improve safety by avoiding surgery, and change the delivery method for sterilization. Gynecologists and women’s health advocates overwhelmingly support the development of new forms of contraception, yet there is little understanding of how women users and male partners would respond to a non-surgical form of permanent sterilization.

The purpose of this qualitative and comparative study is to understand how socio-cultural norms, the historical and medical context of sterilization, and gender-based power dynamics impact attitudes towards permanent contraception. This study will examine the perspectives of the following five groups: 1) married/partnered women; 2) male husbands/partners; 3) mothers-in-law; 4) women’s health providers (OB/GYNs); and 5) women’s health advocates. Through interviews, focus group discussions, and a survey, this comparative study will examine attitudes towards sterilization and surgery, responses to new technology, and contraceptive decision-making in the U.S. (Portland, Oregon) and India (Sevagram, Maharashtra and Delhi). Qualitative data will be analyzed using a grounded theory approach, where emerging themes are analyzed during the data collection period. This study will generate important social science data on issues surrounding permanent contraception that will be useful as new methods of contraception are developed.

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