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临床试验/NCT01989871
NCT01989871Unknown不适用

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

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2013年12月最近更新:
适应症

试验速览

阶段
不适用
入组人数
60
试验地点
2
主要终点
length of hospitalization

研究概览

简要总结

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 .

详细描述

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intervention group will be taught be the nurses (NIDCAP trainees) to identify their infants' ques (self regulation or withdrawn as well as signs of hunger), This parents will be taught the physiology of maturation of feeding, as well as various techniques of infants feeding amongst them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

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Factorial
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
25 Weeks 至 32 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • birth at less than 32 weeks of gestation

排除标准

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

结局指标

主要结局

length of hospitalization

时间窗: 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

次要结局

  • age at reaching full oral feedings(between 34-38 gestational age)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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