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临床试验/NCT02078687
NCT02078687已完成不适用

Growth, Risks of Allergy and Metabolic Syndrome in 6 Year Old Children Born Preterm Compared to Nutrition in the First Four Month After Hospital Discharge

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 239 人开始时间: 2010年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
239
试验地点
1
主要终点
Growth

研究概览

简要总结

This is a follow-up cohort study of 6 years old children born preterm in Denmark from 2004-2008, and at four different neonatal units. During hospitalisation they received breast milk with fortification. At time of discharge there were made 3 different nutrition groups; if possible they were randomised into one of two groups:

  1. Breastfeeding solely
  2. Breastfeeding with fortification

If breastfeeding was not possible they were put in group 3 and were bottle fed with: 3. Preterm formula

This nutrition intervention went on for 4 month. At the age of 6, the children will be invited to come for an ambulant control and other examinations regarding growth, allergy and metabolic syndrome.

详细描述

Project background:

The study is based on a follow-up of a cohort of very preterm infants born before week 32, as at discharge from the neonatal departments were randomized to a protein supplement or not while breastfeeding after discharge. If the preterm child was not breastfed, it received a premature infant formula after discharge. Since we have three groups of prematures, which are fed differently after discharge, it is useful to follow up at 6 years of age and specifically examine the following areas:

Metabolic syndrome:

Unlike the past, the survival rate of very preterm infants is now high. Most is expected to survive. The question is the extent to which these children have increased morbidity compared with children born at term, and their quality of life is affected by the fact that they are born prematurely. There has previously been shown a link between children born SGA and later development of type 2 diabetes mellitus, hypertension, ischemic heart disease and cerebrovascular disasters. Too rapid catch-up growth also increases the possible risk of developing metabolic syndrome in the mature child. The question is whether this is also the case in children born prematurely and whether the risk is the same. The problem is just that you want to provide them with adequate amino acids for protein synthesis, as they approach the growth of peers fetuses and also ensure the development of the brain with essential fatty acids, but maybe they can not tolerate a too rapid "catch-up" - growth.

A study comparing preterm born children aged 4-10 years with mature children born of the same age found that the group with preterm births had increased systolic and diastolic blood pressure and higher insulin levels. This was true regardless of whether the children were born SGA and AGA at birth. This concluded that there were metabolic abnormalities in preterm similar to those found in children born at term but SGA. The same article mentions the concept of "fetal programming". This covers a hypothesis which suggests that a fetus at risk in the uterus will adapt best to survive, and this adjustment will be permanent.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
6 Years 至 8 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Participated in the original study when they were discharge from hospital
  • •Parents accept of participation in the 6 year follow-up

排除标准

  • •Participation not accepted by parents
  • •Genetic diseases with influence on growth

研究组 & 干预措施

Group 2, HMF

Active Comparator

This group received mothers own milk with fortification (human milk fortification, HMF) throughout the 4 month intervention period. Randomisation for group 1 og group 2. Enfamil HM fortifier, Mead Johnson.

干预措施: Mothers own milk (Dietary Supplement)

Group 1, HM

Active Comparator

This group received breastfeeding (human milk, HM) solely throughout the 4 month of intervention. Randomisation for group 1 or group 2. Mothers own milk.

干预措施: Mothers own milk (Dietary Supplement)

Group 2, HMF

Active Comparator

This group received mothers own milk with fortification (human milk fortification, HMF) throughout the 4 month intervention period. Randomisation for group 1 og group 2. Enfamil HM fortifier, Mead Johnson.

干预措施: Enfamil HM fortifier, Mead Johnson (Dietary Supplement)

Group 3, PF

Active Comparator

This group received preterm formula (PF) throughout the intervention period of 4 month. This group was not randomised for ethical reasons. Enfalac Premature Formula, Mead Johnson Nutritionals

干预措施: Enfalac Premature Formula, Mead Johnson Nutritionals (Dietary Supplement)

结局指标

主要结局

Growth

时间窗: Follow-up at approximately 6 years corrected age

Measurement of weight at 6 years corrected age

次要结局

  • Metabolic syndrome(Follow-up at approximately 6 years corrected age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Line Toftlund

PhD student, doctor in medicine

University of Southern Denmark

研究点 (1)

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