TY - JOUR
T1 - Bovine lactoferrin to prevent neonatal infections in low-birth-weight newborns in pakistan
T2 - Protocol for a three-arm double-blind randomized controlled trial
AU - Ariff, Shabina
AU - Soofi, Sajid
AU - Aamir, Almas
AU - D'Almeida, Michelle
AU - Ali, Arzina Aziz
AU - Alam, Ashraful
AU - Dibley, Michael
N1 - Funding Information:
The funds received for this trial from the US Agency for International Development through the University of Sydney (award number AID-OAA-F-17-00013). Manuscript contents are solely the responsibility of the authors and do not necessarily represent the official views of the US Agency for International Development or The University of Sydney or The Aga Khan University.
Publisher Copyright:
© 2021 JMIR Publications Inc.. All right reserved.
PY - 2021/3
Y1 - 2021/3
N2 - Background: Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (<2500 g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin is a natural product with broad-spectrum antimicrobial properties and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but lactoferrin dosage, duration, and role in the prevention of sepsis are still uncertain. Objective: We aimed to establish the efficacy of bovine lactoferrin in the prevention of late-onset sepsis and to determine the optimal dose and method of administering bovine lactoferrin that may contribute to improvement in overall survival of low birth weight infants. Methods: We will implement the study in 2 phases at the Aga Khan University Hospital. The first phase, which we have completed, was formative research. This phase mainly focused on a qualitative exploration of perceptions about feeding and caring practices of low birth weight newborns and a trial of improved practices for the preparation and administration of bovine lactoferrin to newborns. The second phase is a 3-arm double-blind randomized controlled trial. In this phase, we randomly allocated 2 different daily oral prophylactic doses of bovine lactoferrin (150 mg or 300 mg) and placebo to 300 low-birth weight neonates starting within the first 72 hours of birth and continuing for the first 28 days of life. Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University on August 16, 2017. Data collection began in April 2018 and was completed in September 2020. Data analyses are yet to be completed. 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, affordable, and widely utilized treatment to prevent sepsis and, subsequently, may improve the survival outcomes of low birth weight neonates in Pakistan and other lowand middle-income countries.
AB - Background: Sepsis is a common and severe complication in premature neonates, particularly those born with low birth weights (<2500 g). Neonatal sepsis is steadily emerging as a leading cause of neonatal mortality in Pakistan. Lactoferrin is a natural product with broad-spectrum antimicrobial properties and glycoprotein that is actively involved in innate immune host responses. Clinical trials have revealed its protective effect on sepsis, but lactoferrin dosage, duration, and role in the prevention of sepsis are still uncertain. Objective: We aimed to establish the efficacy of bovine lactoferrin in the prevention of late-onset sepsis and to determine the optimal dose and method of administering bovine lactoferrin that may contribute to improvement in overall survival of low birth weight infants. Methods: We will implement the study in 2 phases at the Aga Khan University Hospital. The first phase, which we have completed, was formative research. This phase mainly focused on a qualitative exploration of perceptions about feeding and caring practices of low birth weight newborns and a trial of improved practices for the preparation and administration of bovine lactoferrin to newborns. The second phase is a 3-arm double-blind randomized controlled trial. In this phase, we randomly allocated 2 different daily oral prophylactic doses of bovine lactoferrin (150 mg or 300 mg) and placebo to 300 low-birth weight neonates starting within the first 72 hours of birth and continuing for the first 28 days of life. Results: The study protocol was approved by the Ethics Review Committee of Aga Khan University on August 16, 2017. Data collection began in April 2018 and was completed in September 2020. Data analyses are yet to be completed. 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, affordable, and widely utilized treatment to prevent sepsis and, subsequently, may improve the survival outcomes of low birth weight neonates in Pakistan and other lowand middle-income countries.
KW - Bovine lactoferrin
KW - Human milk
KW - Low birth weight
KW - Mortality
KW - Premature
KW - Sepsis
UR - http://www.scopus.com/inward/record.url?scp=85103200538&partnerID=8YFLogxK
U2 - 10.2196/23994
DO - 10.2196/23994
M3 - Article
AN - SCOPUS:85103200538
SN - 1929-0748
VL - 10
JO - JMIR Research Protocols
JF - JMIR Research Protocols
IS - 3
M1 - e23994
ER -