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临床试验/NCT04277806
NCT04277806已完成不适用

Study on the New Feeding Protocol of Promoting Very Preterm Infants to Attain Full Oral Feeding Earlier

Children's Hospital of Fudan University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年2月15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
120
试验地点
1
主要终点
Age at full oral feeding

研究概览

简要总结

The investigators plan to use a new process to shorten the time of attaining full oral feeding in preterm infants less than 30 weeks gestational age.

详细描述

In the neonatal intensive care unit, the attention of oral feeding of premature infants is far less than that of mechanical ventilation, antibiotics and other medical treatment, the use of parenteral nutrition, etc., and it is often not until the premature infants are enough mature and stable, or even before discharge that the caregivers pay attention to the problem of oral feeding. At this time, the corrected gestational age of premature infants is almost 36 weeks, but in fact the study shows that preterm infants have the ability of self feeding when they are about 32 weeks old. And oral feeding is very helpful to improve their nutritional status, reduce the use of parenteral nutrition and other forms of enteral nutrition, prevent complications and shorten the length of stay. Therefore, this study plans to use a new process to promote oral feeding and to verify whether it is feasible to earlier attainment of full oral feeding in premature infants.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

盲法说明

The randomized allocation was concealed in double-enclosed, opaque, sealed and sequentially numbered envelops and opened when the infant was found to be eligible by the neonatal team in the NICU.

入排标准

年龄范围
1 Hour 至 28 Days(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Preterm infants with gestational age less than 30 weeks
  • •The parents are positive to treat the infants

排除标准

  • •Fetal edema
  • •Very critical with OI more than 40
  • •Apgar score less than 5 at ten minutes after birth
  • •The parents refuse to treat the infants
  • •Severe IVH (more than grade IV )
  • •Died before oral feeding starts

研究组 & 干预措施

Intervention group

Experimental

The preterm infants in this group would be fed according to the new process.

干预措施: New Oral feeding process (Behavioral)

Standard group

No Intervention

No interventions would be conducted in this group and the preterm infants would be fed in the normal way.

结局指标

主要结局

Age at full oral feeding

时间窗: During the procedure

Days of life when the infant attain full oral feeding among two groups.

次要结局

  • Corrected gestational age at full oral feeding(During the procedure)
  • Incidence of complications(During the procedure)
  • The length of hospital stay(During the procedure)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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