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临床试验/NCT06184386
NCT06184386已完成不适用

Efficiency of Parental Feeding Support to Strengthen NIDCAP and Favor Eating Development in Preterm Newborns as Compared With a Retrospective Orofacial Stimulation Standardized and Routine Clinical Practice

University Hospital, Caen1 个研究点 分布在 1 个国家目标入组 43 人开始时间: 2019年2月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
43
试验地点
1
主要终点
The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks

研究概览

简要总结

Preventing oral feeding delays in preterm newborns remains a stake for NICU nowadays. Indeed, it lengthens hospitalization duration, distorts parent-newborns relationships, and increases the risks of adverse nursing outcomes. Does a routine individualized developmental preventive feeding care implying parents favors earlier autonomous oral feeding achievement in preterm newborns as compared with a standardized routine program of orofacial stimulations, despite neonatal risks that every preterm newborn cumulates during hospitalization stay ?

详细描述

The goal of this observational study is to compare the efficiency of two routine preventive feeding care in preterm newborns, taking into account neonatal cumulated risks for each preterm newborn participant. The main question it aims to answer is: Does a prospective individualized routine developmental preventive feeding care leads to earlier oral feeding achievement in preterm newborns despite individual risks, as compared with a retrospective standardized routine program. The group of preterm newborns prospectively assigned in the study will be included in NIDCAP strengthen with a parental support on nursing care named PARENTALIM. The group of preterm newborns retrospectively assigned in the study received orofacial stimulations in a standardized protocol way (SOFS) Researchers will compare prospective and retrospective groups to see if the prospective group achieve autonomous oral feeding, despite individual neonatal cumulated risks, significantly earlier than retrospective group.

研究设计

研究类型
Observational
观察模型
Ecologic Or Community
时间视角
Other

入排标准

年龄范围
3 Days 至 10 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • Parents of preterm newborns born before 34 weeks of amenorrhea
  • Parents who agree participating in the study after signing an informed consent.
  • Minimal delay of 72 hours and maximal delay of 15 days after birth to inform parents and wait their consent.

排除标准

  • Parents of preterm newborns born after 35 weeks of amenorrhea
  • Parents who disagree participating in the study, even after signing the informed consent.
  • Parents of preterm newborns born with cerebral, maxillo-facial, digestive, cardiac, genetic or syndromic abnormalities.

结局指标

主要结局

The precocity of autonomous oral feeding achievement taking into account the index of cumulated neonatal risks

时间窗: 5 years

The corrected age in ammenorhea weeks at which preterm newborn achieve autonomous oral feeding will be divided by the index of cumulated neonatal risks scored from the updated risk inventory initially proposed by Sheiner and Sexton in 1991

次要结局

  • The duration of oral feeding transition(5 years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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