跳至主要内容
临床试验/NCT07461623
NCT07461623撤回不适用

Between Urgency and Efficiency: Assessing the Feasibility of Implementing a Protocol for the Care of Extremely Premature and Very Low Birth Weight Infants During the First Hour of Life: GOLD Study

Centre Hospitalier Universitaire de Nice0 个研究点开始时间: 2026年4月1日最近更新:

试验速览

阶段
不适用
状态
撤回
主要终点
Success of the golden hour protocol

研究概览

简要总结

Premature newborns are a particularly vulnerable population, especially during the first hours of life as they adapt to life outside the womb. This critical period is marked by major physiological instability, particularly among the most immature newborns, i.e., extremely premature infants born before 28 weeks of amenorrhea (SA) or with very low birth weight (<1000g), exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with the prognosis in terms of neonatal morbidity and mortality.

Improving care during the first hour of life-often referred to as the "golden hour"-is crucial for stabilizing these vulnerable newborns. The implementation of a medical and nursing protocol that anticipates and carries out the necessary procedures for these newborns could therefore be a lever for improvement. However, this change in practice is dependent on material conditions, team organization, and the individual needs of the newborn and their family, all of which are variables that can limit or hinder the implementation of what is considered optimal care.

It is therefore necessary to assess both the practical feasibility of such a stabilization protocol during the golden hour and the potential modifiable factors associated with implementation difficulties in order to identify any obstacles, particularly systemic ones. Finally, the association between this change in practice and the prognosis of the premature newborns to whom it is applied should be studied.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
20 Weeks 至 28 Weeks(Child)
性别
All
接受健康志愿者

入选标准

  • All newborns < 28 weeks gestation and/or < 1000g born at Nice University Hospital.
  • Affiliated with French social security;
  • After obtaining the consent of one of the parents or the representative of parental authority.

排除标准

  • - Antenatal pathology involving a limitation of active therapies decided before birth.

结局指标

主要结局

Success of the golden hour protocol

时间窗: 60 minutes

Evaluate the success of implementing the Golden Hour protocol, defined as the time between birth and stabilization in less than or equal to 60 minutes, allowing for the stabilization of the premature newborn. The stabilization of the newborn will be defined by: an established and functional access route, parenteral nutrition initiated, treatments administered, and respiratory stability allowing the incubator doors to be closed.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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