Oral Lactoferrin Prophylaxis to Prevent Sepsis and Necrotising Enterocolitis of Very Low Birth Weight Neonates in Neonatal Intensive Care Unit and Effect on T-regulatory Cells.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Necrotising enterocolitis
研究概览
简要总结
The aim of the study is to evaluate whether oral administration of 200 mg/day lactoferrin (LF) to very low birth weight infants reduces late onset sepsis and necrotising enterocolitis and the effect of LF on regulatory T cells.
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 (Care Provider)
入排标准
- 年龄范围
- 15 Minutes 至 1 Day（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inborn infants
- •Gestational age < 32 weeks
- •Birth weight < 1500 g
- •Parental consent
排除标准
- •Congenital abnormalities
- •Severe perinatal asphyxia
结局指标
主要结局
Necrotising enterocolitis
时间窗: from birth to discharge from NICU
The effect of oral Lactoferrin prophylaxis on severe necrotising enterocolitis (NEC) (Bell's stage 2 and 3) in very low birth infants during the hospitalization period in Neonatal intensive care unit. In case of feeding intolerance, abdominal distention and findings of ileus with clinical deterioration, patient will be evaluated for thrombocytopenia, metabolic acidosis, hyponatremia, blood in stool and radiological findings of NEC. Staging will be performed with clinical, laboratory and radiological findings.
late onset sepsis
时间窗: from birth to discharge from NICU
The effect of oral Lactoferrin prophylaxis on the number of culture proven sepsis attacks in very low birth weight infants during their hospitalization in neonatal intensive care unit. Sterile blood, urine and cerebrospinal fluid samples will be obtained in case of clinical symptoms of sepsis for culture.
Effect on T regulatory cells
时间窗: at discharge
FOXP3 expression on CD4+CD25+ T cells
次要结局
- Safety of lactoferrin in VLBW infants(during the oral use of lactoferrin)
- duration of hospitalization(from birth to discharge from neonatal intensive care unit)
研究者
Ilke Mungan Akin
Neonatologist
Ankara University