Accepted for/Published in: JMIR Research Protocols
Date Submitted: Aug 31, 2020
Open Peer Review Period: Nov 7, 2020 - Nov 17, 2020
Date Accepted: Jan 21, 2021
(closed for review but you can still tweet)
Bovine Lactoferrin to Prevent Neonatal Infections in Low Birth Weight Newborns in Pakistan: Protocol for a Three-arm Double-blinded, Individually Randomized Controlled Trial
ABSTRACT
Background:
Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (LBW) (<2500 g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin (LF) is a natural product with broad-spectrum antimicrobial and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but the lactoferrin dosage, duration, and its role in the prevention of sepsis are still uncertain.
Objective:
To establish the efficacy of bovine Lactoferrin (BLF) in the prevention of late-onset sepsis and to determine an optimal dose and method of administering BLF that may contribute to improvement in overall survival of LBW infants.
Methods:
We will implement the study in two phases at the Aga Khan University Hospital. The first phase will be formative research, which we have completed. This phase mainly focused on a qualitative exploration of perceptions around feeding and caring practices of LBW newborns and a Trial of Improved Practices (TIPs) for the preparation and administration of BLF to the newborns. The second phase will be a three-arm double-blinded, individually randomized controlled trial. In this phase, we will randomly allocate two different daily oral prophylactic doses of BLF (150 mg or 300 mg) and placebo to 300 LBW neonates starting within the first 72 hours of birth continuing for the first 28 days of life.
Results:
The study protocol was approved by the Ethics Review Committee of Aga Khan University, Pakistan on August 16, 2017. Data collection began in April 2018 and was completed in September 2020. Data analyses are yet to be completed. This study will explore the effectiveness of bovine lactoferrin to prevent late-onset neonatal sepsis in LBW neonates, along with identifying the optimal dose and administration methods. We expect the results to be published in peer-reviewed journals by autumn of 2021.
Conclusions:
This intervention, if effective, has the “potential to be translated into a safe, effective, affordable, and widely utilized intervention” to prevent sepsis and subsequently improve survival in LBW neonates in Pakistan, and other low-and middle-income countries. Clinical Trial: ClinicalTrials.gov NCT03431558, https://clinicaltrials.gov/ct2/show/NCT03431558
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