Evaluating the Approach to Administration and Dose of Bovine Lactoferrin to Prevent Neonatal Infections in Low Birthweight Newborns in Pakistan

The University of Sydney
Organization Location: 
Sydney, New South Wales, Australia

Severe infection is the 2nd leading cause of neonatal mortality in Pakistan. Breastfeeding helps protect infants from infections due to multiple anti-infective and immunoregulatory factors including lactoferrin. A trial in Italy found that sepsis and sepsis-related deaths were significantly lower in very low birth weight (LBW) infants who were given daily bovine lactoferrin (bLF) compared to a placebo. A trial from India found a 79% reduction in infections in newborns weighing less than 2000g who received daily bLF from birth until 28 days. Evidence gaps remain about the appropriate daily prophylactic dose, the optimal method to deliver, and the effectiveness of bLF to prevent neonatal sepsis in LBW infants in low resource settings. The goal of this project is to improve newborn survival among LBW infants through a daily prophylactic dose of bLF. A two-stage project will be conducted with formative research followed by RCT to evaluate the appropriate daily dose of bLF and its efficacy in preventing neonatal infections. At the end of the project, an appropriate method to deliver bLF to newborns at home team will have been developed and tested. The most appropriate dose of bLF to prevent neonatal infections in LBW newborns will also be identified. We aim to prevent neonatal infections, as opposed to the current approach which treats neonatal infections when they occur. The current approach depends on early detection of infections though post-natal care and treatment with antibiotics, which leads to the risk of inappropriate use of antibiotics.

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