Phase III, Multicentre, Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy of Probiotic Supplementation for Prevention of Neonatal Sepsis in 0-2 Months old Low Birth Weight Infants in India.


   Meerut Site A: P. L. Sharma District Hospital, Meerut, INDIA

   Meerut Site B: LLRM Medical College, Meerut, INDIA


An estimated 4 Million neonatal deaths occur annually and a quarter of those are attributed to Neonatal Sepsis/ Pneumonia. Substantial reductions are required in infection-specific neonatal mortality in order to achieve Sustainable Development Goal (SDG) 3.2.

Low Birth Weight (LBW) is a risk factor for neonatal deaths. LBW babies are characterized by immune inadequacy, and as such infections are more prone to severe morbidity and mortality.Infection prevention in LBW babies can decrease neonatal morbidity and mortality.Currently antibiotics are used in management of infections in neonates. Indiscriminate usage of antibiotics leads to increased antimicrobial resistance to antibiotics in community

WHO recommends global programs to reduce the use of antibiotics in animals, plants, fishes and in human medicine.Currently no preventive interventions are available for neonatal sepsis other than hygiene related (hand washing and exclusive breastfeeding).

Probiotics with their immuno-modulation/ immuno-potentiation properties can prove an alternative for prevention of sepsis.

Study Setup:

ICMR, New Delhi in collaboration with the six study sites/hospitals in India is conducting a randomized, placebo-controlled, double blind trial to evaluate the efficacy of a probiotic blend (Vivomixx Drop) in reducing the incidence of neonatal sepsis in low birth weight (LBW) infants in the 0-2-month period. A total of 6100 LBW neonates will be enrolled, 3050 each in intervention and control arm. As one of the 6 participating sites, we will be conducting a study in Meerut, UP, India. In this study LBW babies in the identified hospitals, meeting the eligibility criteria will be enrolled and randomized to receive either probiotic Vivomixx or a similar looking substance (placebo), once daily for 30 days. Follow up visits will be done daily at home during the first week of life, twice a week during second to fourth week of life, and weekly during the second month. During these visits, field worker will screen the infants for morbidity and refer the sick infants to the study hospital for evaluation by the physician. At the facility/hospital, examination for clinical signs, blood samples from sick infants suspected sepsis for diagnosis of neonatal sepsis will be done.