Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Neonatal Sepsis
研究概览
简要总结
Lactoferrin (LF) is a multifunctional glycoprotein and is naturally present in various body secretions, including human milk, tears, saliva, airway mucus, and the secondary granules of neutrophils 1-2. It plays a crucial role in innate infant immunity by exerting immunomodulatory, antimicrobial and anti-inflammatory effects. The biochemical and molecular properties of LF, such as ferric iron transport, enzymatic activity, and nuclear binding for transcriptional regulation, essentially make it a versatile defense molecule in host-pathogen interactions. Sepsis remains leading cause of morbidity and mortality in vulnerable populations , placing significant burdens on healthcare systems and families. Despite advancements in neonatal care, strategies to effectively reduce these risks remain limited, necessitating a focus on prophylactic interventions that are safe and evidence-based. This study is designed to fill the gaps of possible preventive strategy for sepsis among premature babies and to evaluate the effectiveness of enteral lactoferrin supplementation in decreasing the clinical sepsis among preterm neonates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 37 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm Neonates (Neonates who are born before the completion of 37 weeks of pregnancy)
- •Low birth weight infants less than 2500 grams at birth
- •Recruited within the first 72 hours after birth
- •Admitted to the Neonatology department
排除标准
- •Neonates born with congenital anomalies
- •Newborns with infections identified at the time of birth, signs of infection on admission (fever, respiratory problems, etc.), or infection detected by the physician.
研究组 & 干预措施
Group A participants with standard treatment
Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. Group A is control group with standard treatment only
Group B participants
Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. In Group B bovine lactoferrin was given orally at a dose of 150 mg/kg/day once within 72 hours of birth.
干预措施: Bovine Lactoferrin Supplement (Biological)
结局指标
主要结局
Neonatal Sepsis
时间窗: 7 Days
Neonatal Sepsis Score was used to assess clinical severity of sepsis
次要结局
未报告次要终点
研究者
Zartash Sial Paeds Med
Principal Investigator
King Edward Medical University