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Bovine Lactoferrin and Neonatal Survival in Low Birth Weight Babies.

NCT03431558 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2020-04-09

No results posted yet for this study

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.

Conditions

  • Neonatal Sepsis
  • Necrotizing Enterocolitis

Interventions

COMBINATION_PRODUCT

bLF (Bovine lactoferrin)

BLF administration in two different strengths (150 \& 300mg) will be given on the third day of life with a single daily dose mixed with milk for 1 month.

DRUG

Glucon-D 99.4% (Placebo)

This group will be given 100mg Glucon-D (99.4% glucose) placebo which will be similar in shape, color to the bLF.

Sponsors & Collaborators

  • University of Sydney

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • Aga Khan University

    lead OTHER

Principal Investigators

  • Shabina Ariff, MBBS,FCPS · Aga Khan University

  • Michael J Dibley, MB BS, MPH · University of Sydney

  • Almas Aamir, MSC · Aga Khan University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
48 Hours
Max Age
72 Hours
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-05-01
Primary Completion
2020-05-31
Completion
2020-05-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03431558 on ClinicalTrials.gov