Effect of Bovine Colostrum On T-Regulatory Cells, Prevention Of Late Onset Sepsis And Necrotizing Enterocolitis In Preterm Neonates
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- The incidence of Necrotizing Enterocolitis in the three groups
研究概览
简要总结
The aim was to assess the ability of bovine colostrum concentrate to reduce the incidence of late-onset sepsis episodes and necrotizing enterocolitis in artificially fed preterm neonates and its effect on T regulatory cells. And to evaluate the effect of bovine colostrum concentrate on feeding tolerance, growth, hospital stay and mortality in preterm neonates.
详细描述
The study was interventional, double blinded and randomized trial ، performed on preterm neonates( <34 week) admitted on Ain ShamsUniversity (ASU) neonatal intensive care units (NICU) after considering exclusion criteria.
The enrolled patients was subdivided into two groups; group A are infants with non bovine colstrum and group B with bovine colostrum All infants received the standard neonatal care and underwent follow-up from birth until reach 37 week corrected gestational age, discharge or death whichever came first.
I. Data Collection: Careful history taking
- Antenatal history including: rupture of membrane, Chorioamnionitis, history of urinary tract infection.
- Natal history including: mode of delivery, place of delivery, the need for resuscitation, recorded Apgar score at 1minute and 5 minutes.
- Postnatal history including: age of admission in neonatal intensive care unit, symptoms suggest infection.
II. Thorough clinical assessment:
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 24 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Preterm Neonate having a gestational age equal or less than 34 weeks at birth, admitted in Ain-Shams University NICUs
排除标准
- •• Maternal risk factor of early onset sepsis, chorioamnionitis.
- •Proved early onset sepsis.
- •Life-threatening congenital abnormalities.
- •Inborn error of metabolism.
- •Chromosomal aberrations.
- •Neonates with underlying gastrointestinal problems (such as GIT anomalies) that prevent enteral feeding.
- •Perinatal asphyxia.
结局指标
主要结局
The incidence of Necrotizing Enterocolitis in the three groups
时间窗: From time of randomization to discharge from nicu or death whichever comes first
Incidence of Necrotizing Enterocolitis in the three groups diagnosed according to bell's staging
Incidence of Late Onset Sepsis in the three groups
时间窗: From time of randomization to discharge from nicu or death whichever comes first
Incidence of Late Onset Sepsis in the studied group measured by rodwell and tollner sepsis scoring system
The change of Active T regulatory cells In the three groups
时间窗: Change from base line at randomization and after intervention by 1 week
Active T regulatory cells diagnosed by cell CD 4 expressing CD 25 high or simultaneously CD 25 plus FOXP3
次要结局
- Duration of hospital stay(From time of randomization to discharge from nicu or death whichever comes first)
- Feeding intolerance is defined as presence of at least 3 consecutive days of any of the following:emesis, gastric residuals, diarrhea, blood in stools or abnormally enlarged bowel loops(From time of randomization to discharge from nicu or death whichever comes first)
- Neonatal mortality(From time of randomization to discharge from nicu or death whichever comes first)
研究者
Rania Ismail
Clinical professor
Ain Shams University