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Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm Infants

2013年11月14日 更新者:Sheba Medical Center

Adjusted Individual Oral Feeding for Improving Short and Long Term Outcomes of Preterm

The authors hypothesize that adjusted individual feeding (AIF) for preterm infant starting from transition to oral feeding (33 weeks corrected age) will result in less episodes of apnea/bradycardia, early achievement of full oral feeding, improved weight gain and shorten hospitalization duration in the short term.

In the long term AIF will result in higher scores on the Griffith's developmental scales, decreasing parental anxiety and feeding disorders .

研究概览

详细说明

Preterm infants born at <32 weeks of gestation at our institute will qualify for this study. Recruitment will occur between day 7-14 of life after sever brain malformations or intraventricular bleeding will be ruled out. Randomization to control or intervention will be via sealed envelopes. In the control group - infants will be treated according to the common practice in the neonatal intensive care unit. Transition to oral feeding will occur at 33 wkks (breast feeding) and 34 wks (bottle feeding). Meals will be given every 3 hours, the amount will be written by the care giving physician and will be written as a strict number (i.e 30 ml every 3 hours) Parents in the intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them pace feeding. During the study parents in both groups will be interviewed every 14 days as for their satisfactions, anxieties, infants ability to cope. video typing during Kangaroo care at 32 and 35 wks as well as during feeding at 35 weeks will be done and evaluated. General movements assessment (neurodevelopment) will be done at 33 -35 weeks gestational age, as well as at 52 weeks. Alberta infant motor scales will be evaluated at 4 and 8 month corrected age,Automated Brain stem evoked Response (ABR) will be done at 33 wks for assessment of brain stem maturity, duration of hospitalization, weight gain per week at 33, 34 and 35 weeks will be calculated, age at full oral feeding will be noted. At the age of 6 month Griffith's developmental scales will be performed

研究类型

介入性

注册 (预期的)

60

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

      • Ramat Gan、以色列、52621
        • Sheba medical center

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

5个月 至 7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:

- birth at less than 32 weeks of gestation

Exclusion Criteria:

  • High grade intraventricular hemorrhage (grade 3 or4)
  • genetic syndrome

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:预防
  • 分配:非随机化
  • 介入模型:阶乘赋值
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
无干预:protocol feeding
Feeding of preterm infants according to current unit protocol: every 3 hours a prescribed amount
实验性的:Adjusted individual feeding
Feeding every 2-4 hours, starting with que of hunger and finished upon infant signs.
Feeding every 2-4 hours, starting with ques of hunger and finished upon infant signs.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
length of hospitalization
大体时间:between 36-40 weeks gestational age
length of hospitalization from admission to discharge, and length of stay beyond reaching 36 weeks corrected age , the time point at wich health infants are usually being discharged
between 36-40 weeks gestational age

次要结果测量

结果测量
措施说明
大体时间
age at reaching full oral feedings
大体时间:between 34-38 gestational age
the age at which no nasogastric tube was used
between 34-38 gestational age

其他结果措施

结果测量
措施说明
大体时间
Griffith's developmental scales
大体时间:6 month corrected age
Griffith's developmental scales (Gross and fine motor, speech and language, performance and social skills)
6 month corrected age
weekly weight gain
大体时间:33- 36 weeks gestational age
weekly weight gain gr/kg will be calculated at 33 weeks gestational age, at 34, 35, and 36 weeks
33- 36 weeks gestational age
parental anxiety
大体时间:6 month corrected age
parents anxiety will be assessed by a questioner
6 month corrected age

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:Iris Morag, MD、Sheba medical center

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

2013年12月1日

初级完成 (预期的)

2014年12月1日

研究完成 (预期的)

2015年12月1日

研究注册日期

首次提交

2013年11月6日

首先提交符合 QC 标准的

2013年11月14日

首次发布 (估计)

2013年11月21日

研究记录更新

最后更新发布 (估计)

2013年11月21日

上次提交的符合 QC 标准的更新

2013年11月14日

最后验证

2013年11月1日

更多信息

与本研究相关的术语

其他研究编号

  • SHEBA-12-9574-IM-CTIL

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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