drugset / Trial / NCT03431558

Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.

NCT03431558

RandomizedParallel-groupQuadruple-blindPrevention

Summary

Pakistan has the third highest number of neonatal deaths worldwide. During the last two decades (1990-2013), neonatal mortality rate in the country has declined by only 1.0% per year. Severe infection is the second most leading cause of neonatal mortality, account for 28% of all deaths in Pakistan. Majority of neonatal deaths occur in infants who LBW (birth weight \<2500g) and LBW comprises of both preterm / small for gestational age newborns. Breastfeeding helps protect infants from infections by serving as a source of nutrition uncontaminated by environmental pathogens. The protection is due to the multiple anti-infective, anti-inflammatory, and immuno regulatory factors transmitted through milk including secretory antibodies, glycan's, Lactoferrin, leukocytes, cytokines \& other components produced by the mother's immune system. Reduction in neonatal infections and deaths is the aim of this study. The study is being conducted at the Aga Khan University in collaboration with University of Sydney.

Timeline

Start
2018-05-01
Primary completion
2020-05
Completion
2020-05

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Lactoferrin Protein / enzyme biologic 150 mg Oral
Subject Lactoferrin Protein / enzyme biologic 300 mg Oral