Can Bovine Lactoferrin Prevent Neonatal Infections in Low Birth Weight Babies in Karachi, Sindh, Pakistan.

NCT03431558 Phase 3 UNKNOWN

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.

Details

Lead sponsor	Aga Khan University
Phase	Phase 3
Status	UNKNOWN
Enrolment	300
Start date	2018-05-01
Completion	2020-05

Conditions

• Neonatal Sepsis
• Necrotizing Enterocolitis

Interventions

• bLF (Bovine lactoferrin)
• Glucon-D 99.4% (Placebo)

Primary outcomes

• Late onset sepsis (LOS) in Low Birth Weight. — 1 month
  Reduction in late onset sepsis (LOS) in Low Birth Weight babies.
• Optimal dosage of bLF — 1 month
  Deduce optimal dosage of bLF in LBW babies.

Countries

Pakistan