Effect of Intake in Bioactive Molecules From Natural or Pasteurised Milk on Gut Maturation in Very Premature Newborns
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- pasteurized milk
研究概览
简要总结
It seems important to correlate real consumption in bioactives molecules of natural milk versus pasteurized with gut maturation in very preterm infants during small enteral feeding protocol. This objective will be reached through a clinical trial.
详细描述
One hundred infants born between 28 and 30 weeks of gestational age will be enrolled in our clinical trial in two neonatal units of Marseille; they will receive small enteral feeding protocol with natural or pasteurized milk (according to the Neonatology Department). Infants monitoring will be conducted from birth until 32 weeks of gestational age through extra-uterine growth, dietary type evolution and determination of gut maturation markers levels in blood (Triglycerides and Cholesterol, PUFA, GLP-2, I and L-FABP, Gastrin, Citrullin) and faeces (Calprotectine). We will also look for new biological markers of intestinal growth, via metabolomic approach. Consumption of bioactives molecules (PUFA, sphingomyelin, sCD14, insulin, leptin, lactoferrin, sphingomyelinase acid and BSSL activity) will be quantified in milk 24h-representative samples received by each newborn. The benefits on digestive tract physiology evolution due to the molecules consumption will be observed from the 32nd week until the 36th week or the end of hospitalization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 1 Day 至 1 Week（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children whose term is understood(included) between 28 (27SA+6j past(over)) and 30 LIMITED COMPANIES (30 SA+6j).
- •Children fed by digestive stimulation.
- •Children in 1st day of food(supply)
- •Term of certain child.
- •Children not presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- •Children among whom both holders of the parental authority are of more than 18 years old and are not major protected by the law or deprived of freedom.
- •Children among whom the relatives(parents) or the legal representatives accepted the participation of their child in this study, and having signed a lit(enlightened) consent.
排除标准
- •Children been born > 30 LIMITED COMPANIES and < 28 limited companies.
- •Children presenting a genic syndrome, an evolutionary neurological disease, a pathology malformative.
- •Children among whom the relatives(parents) or the legal representatives refused that their child participates in the study.
研究组 & 干预措施
natural milk
干预措施: blood samples, feces samples (Other)
pasteurized milk
干预措施: blood samples , feces samples (Other)
结局指标
主要结局
pasteurized milk
时间窗: 2 years
infants born between 28 and 30 weeks of gestational age will receive small enteral feeding protocol with pasteurized milk
次要结局
- natural milk(2 years)