Ariff Shabina, Soofi Sajid, Aamir Almas, D'Almeida Michelle, Aziz Ali Arzina, Alam Ashraful, Dibley Michael
Department of Pediatric and Child Health, Aga Khan University, Karachi, Pakistan.
School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
JMIR Res Protoc. 2021 Mar 11;10(3):e23994. doi: 10.2196/23994.
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.
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.
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.
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.
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.
ClinicalTrials.gov NCT03431558; https://clinicaltrials.gov/ct2/show/NCT03431558.
INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/23994.
脓毒症是早产儿尤其是低出生体重儿（<2500g）常见且严重的并发症。在巴基斯坦，新生儿脓毒症正逐渐成为新生儿死亡的主要原因。乳铁蛋白是一种具有广谱抗菌特性的天然糖蛋白，积极参与先天性免疫宿主反应。临床试验已揭示其对脓毒症的保护作用，但乳铁蛋白的剂量、持续时间以及在预防脓毒症中的作用仍不确定。
我们旨在确定牛乳铁蛋白预防晚发性脓毒症的疗效，并确定可能有助于改善低出生体重儿总体存活率的牛乳铁蛋白最佳剂量和给药方法。
我们将在阿迦汗大学医院分两个阶段开展该研究。第一阶段即我们已完成的阶段，是形成性研究。该阶段主要侧重于对低出生体重新生儿喂养和护理实践认知的定性探索，以及对改善牛乳铁蛋白给新生儿制备和给药实践的试验。第二阶段是一项三臂双盲随机对照试验。在此阶段，我们将出生后72小时内开始、持续至出生后28天的300名低出生体重新生儿随机分为两组，分别每日口服两种不同剂量的牛乳铁蛋白（150mg或300mg）及安慰剂。
该研究方案于2017年8月16日获得阿迦汗大学伦理审查委员会批准。数据收集于2018年4月开始，2020年9月完成。数据分析尚未完成。我们预计结果将于2021年秋季在同行评审期刊上发表。
该干预措施若有效，有可能转化为一种安全、经济且广泛应用的预防脓毒症的治疗方法，进而可能改善巴基斯坦及其他低收入和中等收入国家低出生体重新生儿的生存结局。
ClinicalTrials.gov NCT03431558；https://clinicaltrials.gov/ct2/show/NCT03431558。
国际注册报告识别码（IRRID）：PRR1-10.2196/23994。
