Status:
UNKNOWN
Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.
Lead Sponsor:
Aga Khan University
Collaborating Sponsors:
University of Sydney
United States Agency for International Development (USAID)
Conditions:
Neonatal Sepsis
Necrotizing Enterocolitis
Eligibility:
All Genders
48-72 years
Phase:
PHASE3
Brief 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...
Detailed Description
Globally, severe infection is the second leading cause of neonatal mortality. It is one of the indirect leading causes of death in a world. According to Annual report, 28% neonatal deaths were due to ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03431558
Start Date
May 1 2018
End Date
May 1 2020
Last Update
April 9 2020
Active Locations (1)
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1
Aga Khan University Hospital
Karachi, Sindh, Pakistan, 74800