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临床试验/NCT00764179
NCT00764179终止不适用

Effects (Long Term Analysis) of an Hyperproteinic Nutrition on Neonates With Intra-uterine Growth Delay : a Prospective, Multicentric , Randomized, Double Blind Study ("Proneonat")

Nantes University Hospital2 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2008年3月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
93
试验地点
2
主要终点
Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2

研究概览

简要总结

Neonates with intra-uterine growth delay represent more than 2% of the 800 000 annual births in France. Studies have shown that milks enriched with protein allow to accelerate newborns growth. According to some papers, growth acceleration would have a favourable effect on psycho-motor development at age of 2 or 3. However, for other authors, this would not lead to any benefit and even an early hyperproteinic feeding would have bad long term consequences such as appearance of several diseases in the future adult (overweight, diabetes, arterial hypertension, renal function alteration).The main objective of this clinical trial is to check that an hyperproteinic feeding does not lead to any benefit on psycho-motor development at age of 2, compared with a milk containing same level of protein than milk proposed to newborns of normal weight. The secondary objectives of our clinical trial are to compare the effects of these two types of milk on renal function, arterial blood pressure, body composition, corpulence, food preferences, insulin resistance and intestinal integrity at age of 2. A sub study will also be realized to analyse the proteic turn over . This sub-study will be undertaken only with neonates of Nantes Hospital.

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
34 Weeks 至 39 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Neonates with intra-uterine growth delay (with weight < 10th centile)
  • Aged >34 weeks of amenorrhoea
  • For neonates >38 weeks of amenorrhoea, weight < 2500g
  • Mother's refusal of breast feeding
  • Informed consent signed by the 2 parents
  • Possibility to follow newborns until age of 2

排除标准

  • Subject not fulfilling inclusion criteria
  • Severe disease (syndrome and/or congenital abnormality, deficiency of metabolism at birth)

结局指标

主要结局

Quotient of psycho-motor development evaluated by the Brunet-Lezine test at age of 2

时间窗: at 2 years old

次要结局

  • Plasmatic and urinary citrulline levels(At age of 15 (+/- 2) days and at age of 2 years)
  • Leptine, glycemia/insulin and pro-insulin blood level(At age of 15 (+/- 2) days and at age of 2 years)
  • Micro-albuminuria, creatinine, urea, sodium and potassium urine levels(At age of 15 (+/- 2) days and at age of 2 years)
  • Faecal floa, faecal calprotectine and other markers(At age of 15 (+/- 2) days and at age of 2 years)
  • Arterial blood pressure, arterial elasticity, adiponectine, preferential food choices, kidney size(at age of 2 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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