Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.
Neonatal Sepsis, Necrotizing Enterocolitis
About this trial
This is an interventional prevention trial for Neonatal Sepsis focused on measuring Bovine Lactoferrin, Neonatal infection, Low Birth Weight
Eligibility Criteria
Inclusion Criteria:
Neonates with:
birth weight ≤ 2500 g and ≥ 1000 grams. gestational age ≥ to 28 +0 weeks to 36+6. family planned on staying in the study area for at least 1 month • parents/ caretaker willing to provide consent. newborn initiated enteral feeding via (gavage feeding with expressed breast milk or formula, direct breast feeding or cup and spoon feeding at or within 48 hours of birth.)
Exclusion Criteria:
Neonate with congenital anomalies. early-onset sepsis. birth weight less than 1000 g. gestational age less than or equal to 27weeks+6 days. history of Chorioamnionitis or maternal group B streptococcus colonization. Reversed or absent end-diastolic flow on maternal umbilical artery Doppler where available.
Sites / Locations
- Aga Khan University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Placebo Comparator
Group 1
Group 2
Group 3
bLF (Bovine Lactoferrin plus Glucan D 99.4%) Dose: 150 mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk). Duration: 1 month
bLF (Bovine Lactoferrin plus Glucan D 99.4%) Dose: 300mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk). Duration: 1 month
Placebo: Only Glucan-D (99.4% glucoseDose: 150 mg Frequency: a single daily dose mixed with milk (preferentially breast milk otherwise formula milk). Duration: 1 month