Effect of Early Enteral Supplementation of L-arginine and Glutamine on Preterm Neonate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- NEC incidence, stage and outcome
研究概览
简要总结
effects of enteral l-arginine to decrease feeding intolerance and risk of NEC in neonates via its role as a NO precursor. Also, enteral glutamine which may play a role as an immunomodulator on preterm neonates. all these had never been studied in developing countries where sepsis and nec act as a major participant in mortality rates.
详细描述
Necrotizing enterocolitis (NEC) is the most common acquired gastrointestinal disease that occurs predominantly in premature infants and is considered to be one of the leading causes of morbidity and mortality in their age group (Schnabl et al., 2008).
Primary prevention of NEC should be the priority, since NEC frequently progresses from nonspecific signs, to extensive necrosis within a matter of hours with medical or surgical treatment, making successful treatment and secondary prevention difficult to achieve (Lin et al., 2013).
One of the assumed novel preventive measures against NEC is L-arginine & glutamine supplementation to high risk infants (Neu, 2005).
We conducted a prospective, interventional, single blinded clinical study in the period from 1/2011- 3/2014 in both NICUs of Children Hospital & Maternity Hospital of Ain Shams University. The study was approved by the Ethical Committee of Faculty of Medicinie, Ain Shams University.
Aim of the study was to assess the preventive role of enteral L-arginine & glutamine against NEC and to assess the role of glutamine in decreasing the impact of sepsis on premature 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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≤34 weeks
排除标准
- •Severe congenital anomalies.
- •Congenital non-bacterial infection
- •Evidence of intraventricular hemorrhage (IVH) grade ≥II on cranial ultrasound scan by day 3 of life
- •Conjugated hyperbilirubinemia
- •Evidence of an inborn error of metabolism
- •Exchange transfusion during the study period
研究组 & 干预措施
glutamine, PT, sepsis
enteral or via NG tube dose of 312mg/kg/day divided every 12 hours from starting feeding up to 30 says post natal age + usual care and medications
干预措施: Glutamine (Drug)
L-arginine,NEC, PT
enteral or via NG tube dose of 260 mg/kg/day divided every 12 hours from starting feeding up to 30 says post natal age + usual care and medications
干预措施: l-arginine (Drug)
结局指标
主要结局
NEC incidence, stage and outcome
时间窗: age of 28 days of life
determining the incidence, stage and outcome of NEC in both l-arginine receiving and control groups
次要结局
- Sepsis(age of 28 days of life)
研究者
ghada saleh
G. Saleh
Ain Shams University