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 low- and middle-income countries. Trial Registration ClinicalTrials.gov NCT03431558; https://clinicaltrials.gov/ct2/show/NCT03431558 International Registered Report Identifier (IRRID) PRR1-10.2196/23994
Background: Infection is the second most leading cause of neonatal deaths in Pakistan. Lactoferrin is a naturally occurring protein found in human milk which can prevent neonatal infections and improve the survival of high-risk, low birth weight newborns. Bovine lactoferrin (bLF) has been recognized as a safe nutrient with no adverse effects. The aim of this study was to explore routine newborn care practices, care seeking attitudes, and assess the acceptability and the optimal method of administering bLF at the household level.Method: Exploratory qualitative research design was adopted. Thirty in-depth interviews with mothers, grandmothers and fathers of low birthweight (LBW) infants were conducted at postnatal wards and the neonatal intensive care unit (NICU) of the Aga Khan University Hospital. Eleven of these families were also recruited for a trial of improved practices (TIPs) to assess the feasibility and the method of administration of bLF prior to the main trial. Interviews were recorded and analyzed using thematic analysis.Result: Most study participants consider birthweight as a predictor of neonatal health outcomes. Caring of LBW newborns was identified as a physically and emotionally overwhelming experience. Majority of mothers believed that LBW babies are prone to infections, gastrointestinal, respiratory and developmental problems. Fathers and grandmothers were major decision makers in the family and supported the use of bLF in LBW newborns. Parents, who used bLF were satisfied with feeding method and frequency of bLF. Conclusion: Our formative study found that participants were willing to use bLF for feeding LBW babies. However, educating mothers, fathers and grandmothers is crucial for successful uptake of the intervention. Bovine lactoferrin is a safe and easy to administer according caregivers of LBWs babies. It also has potential to be translated into a safe and effective intervention for LBW babies to prevent sepsis.Trial registration: ClinicalTrials.gov identifier: NCT03431558.
Objective We examined associations between fat free mass (FFM) and fat mass (FM) accretion during the first 1000 days of life and neurodevelopment in term-born, low-risk infants from Karachi, Pakistan. Design Prospective, observational study nested within the larger Multi-Center Body Composition Reference Study. FFM, FM, and fat% were estimated using measured deuterium dilution method. Neurodevelopmental outcomes were assessed at 24 months on the INTER-NDA (INTERGROWTH-21st Project Neurodevelopment Assessment) (n = 132). Results Children with gross motor delays had significantly lower FFM at 18 months (8.01 ± 0.97 kg vs. 7.55 ± 0.20 kg). Children with positive and negative behavior problems had significantly higher fat% at 24 months (20.62 ± 4.30% vs. 18.23 ± 5.46%) and 20.89 ± 4.24% vs. 18.54 ± 5.38%). No associations remained significant after adjusting for covariates. Trajectory modeling showed that between 12 and 18 months, negative behavior scores changed by 13.8 points for every standard deviation change in fat accretion. Conclusions Our findings highlight the importance of balancing neurodevelopment and metabolic risk when designing nutritional interventions for young children.
BACKGROUND 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 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 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 Trial ongoing CONCLUSIONS Trial ongoing CLINICALTRIAL Trial registration: ClinicalTrials.gov identifier: NCT03431558.
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