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Target Fortification of Breast Milk: How Often Breast Milk Needs to be Measured? (TFO2)

2016年8月10日 更新者:Christoph Fusch、McMaster Children's Hospital

Target Fortification of Breast Milk: The Effect of Different Schedules for Milk Analysis on the Growth and Development of Preterm Infants.

It has been observed that target fortification on different schedules leads to meal to meal variation. It changes the ratio of protein to energy and the percentage of carbohydrate to non-protein energy which may, affect growth. In the past, the investigators have analyzed the outcomes of breast milk composition when target fortification is done with different analysis schedules. The investigators were able to measure the macronutrient intake for different milk analysis schedules via a theoretical model and show that the more frequent schedules reduce the variation of fortified-breast milk, whereas a reduced schedule leads to a high variation of macronutrients. It was observed that, in all the breast milk samples measured twice per week, infants achieved on average the recommended macronutrients in line with current recommendations. Nonetheless, the model only looks at the macronutrient intake and does not investigates the relationship between macronutrient variation and its effect on growth.

The aim of the current study is to compare a frequent schedule of measurement of macronutrient analysis with a reduced schedule of measurement and to study its affect on growth, protein accretion and metabolic parameter.

研究概览

研究类型

介入性

注册 (预期的)

56

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

    • Ontario
      • Hamilton、Ontario、加拿大、L8S 4K1
        • Faculty of Health Science, McMaster Children's Hospital

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

不超过 6个月 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Gestational age < 30 weeks (maternal dates or early fetal ultrasound);
  2. Tolerating an enteral intake of ≥100 mL/kg/d for ≥ 24h;
  3. Subject is anticipated to receive the intervention for ≥ 3 consecutive weeks after full enteral feeding (≥150 mL/kg/d) has been achieved;
  4. Written informed consent has been obtained from the infant's legal representative.
  5. Multiple births: Each infant will be included in the study if he/she meets the study criteria, and siblings will be individually randomized to one or other of the treatment arms.
  6. Discussion with Most Responsible Physician (MRP) and the staff in order to discuss any potential transfer during the next 7 days.

Exclusion Criteria:

  1. Gastrointestinal malformation, major congenital anomalies and chromosomal abnormalities;
  2. Babies with enterostoma or short gut syndrome;
  3. Infants fed more than 25% of mean caloric intake for a consecutive week with formula milk;
  4. Fluid restriction <140 mL/kg/d for ≥ 3 consecutive days;
  5. Sepsis - all infants with gram-negative sepsis will be removed from the study;
  6. Necrotizing enterocolitis, defined by feeding intolerance associated with positive x-ray findings (pneumatosis intestinalis - Bell Stage 2; air in the biliary tract or free air in the peritoneum - Bell Stage 3);
  7. Renal disease, defined by symptoms (oliguria, anuria, proteinuria, hematuria) associated with an increased blood urea nitrogen >10 mmol/L and creatinine of 130mmol/L
  8. Participation in another clinical trial that may provide an alternative nutritional intervention, which might affect the outcomes of this study. outcomes of this study;
  9. Probability of transfer to another neonatal intensive care unit or level II nursery outside the McMaster Children's Hospital, as discussed with the most responsible physician (MRP)

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:四人间

武器和干预

参与者组/臂
干预/治疗
实验性的:5 milk analysis
  1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed five times per week, of native breast milk batches which had been prepared for 24 hours feeding.
  2. Routine fortifier will be added to breast milk batches.
  3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
实验性的:1 milk analysis
  1. Macronutrient content (for protein, carbohydrate and fat content) will be analyzed once per week of native breast milk batches which had been prepared for 24 hours feeding.
  2. Routine fortifier will be added to breast milk batches.
  3. Modular products for individual adjustment of protein and/or carbohydrate and/or fat will be given in order to achieve target macronutrient level.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.
Modular product supplementation is based on most recent breast analysis done for the participant.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Growth during first three weeks of intervention
大体时间:first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation

次要结果测量

结果测量
措施说明
大体时间
Daily Nutrient intake (kcal, lactose, protein, fat) measured with conventional milk analysis
大体时间:from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation
Weight Gain
大体时间:from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
from inclusion at postmenstrual age <30 weeks until 36 weeks of gestation or discharge
Oxidative stress by 8-Oxo-2'-deoxyguanosine metabolites in urine
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
Measured by mass spectroscopy
from inclusion at postmenstrual age <30 weeks until discharge
Protein synthesis analyzed by nitrogen excretion in urine [µmol/mL]
大体时间:first three weeks during intervention before 36 weeks of gestation
first three weeks during intervention before 36 weeks of gestation
Feeding intolerance questionaire
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
volume of gastric residuals, color of gastric residuals, vomiting, abdominal girth, abdominal distention
from inclusion at postmenstrual age <30 weeks until discharge
Fat mass [g]
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
Measured with bioelectrical impedance analysis
from inclusion at postmenstrual age <30 weeks until discharge
Lean mass [g]
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
Measured with bioelectrical impedance analysis
from inclusion at postmenstrual age <30 weeks until discharge
Head circumference [cm]
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
Measured by tape
from inclusion at postmenstrual age <30 weeks until discharge
Body length [cm]
大体时间:from inclusion at postmenstrual age <30 weeks until discharge
Measured by length board
from inclusion at postmenstrual age <30 weeks until discharge

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Christoph Fusch, MD, PhD、McMaster Children's Hospital

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2016年9月1日

初级完成 (预期的)

2017年6月1日

研究完成 (预期的)

2019年6月1日

研究注册日期

首次提交

2016年8月8日

首先提交符合 QC 标准的

2016年8月10日

首次发布 (估计)

2016年8月15日

研究记录更新

最后更新发布 (估计)

2016年8月15日

上次提交的符合 QC 标准的更新

2016年8月10日

最后验证

2016年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2016TFO2

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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