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A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns (PREM-GH)

2026年9月14日 更新者:Centre Hospitalier Universitaire de Nice

A Study of Factors Associated With Failure of the Golden Hour Protocol in the Initial Care of Extremely Preterm and Very Low Birth Weight Newborns - PREM-GH

Preterm infants 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 significant physiological instability, particularly among the most immature newborns-that is, extremely preterm infants born before 28 weeks of gestation (WG) or with very low birth weight (<1000 g)- exposing them to acute complications such as hypothermia, hypoglycemia, severe respiratory distress, or hemodynamic instability. All these factors are known to be associated with neonatal morbidity and mortality.

Improving care during the first hour of life-often referred to as the "golden hour"-is critical to stabilizing these vulnerable newborns. Therefore, implementing a medical and nursing protocol that enables the anticipation and execution of the necessary interventions for these newborns is a key driver of improvement. To this end, since March 2025, we have implemented a protocol to optimize care during the first hour of life for extremely preterm and very low birth weight newborns. However, this change in practice is influenced by material conditions, team organization, and the individual needs of the newborn and their family, and involves multiple variables that may limit or hinder the implementation of care considered optimal.

Thus, it is necessary to assess the potential modifiable factors associated with difficulties in implementing care during the first hour of life.

研究概览

地位

尚未招聘

条件

研究类型

介入性

注册 (估计的)

50

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。

学习联系方式

学习地点

    • Alpes-Mritimes
      • Nice、Alpes-Mritimes、法国、06200
        • CHU Nice - Hôpital de l'Archet 2
        • 接触:

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 6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:

  • Newborns at 23-27 weeks' gestation + 6 days (< 28 weeks' gestation) and/or with a birth weight between 450 g and 999 g (< 1,000 g) born at the Nice University Hospital; (weight estimated prenatally and confirmed at birth) To implement the protocol for newborns weighing < 1,000 g, the weight used is that estimated by an ultrasound performed before birth.
  • Enrolled in the insurance ;
  • After obtaining consent from the parents or the legal guardian.
  • All eligible patients during the study period will be included consecutively

Exclusion Criteria:

  • Prenatal condition requiring a decision made before birth to limit active treatment (severe genetic abnormality [e.g., trisomy 18], need for extensive medical and/or surgical care that is not compatible with delivery at extreme term [e.g., esophageal atresia with delivery at 24 weeks' gestation]). Decision made before birth by the obstetric-pediatric team;
  • A newborn with a confirmed birth weight of more than 1,000 grams.

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:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
其他:Golden hour protocol

Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth

Feasibility of the Golden Hour protocol for stabilizing preterm newborns within 60 minutes of birth.

The entire packaging process of the newborn will be determined by: an established and functional access route, initiation of parenteral nutrition, administration of treatments, and respiratory stability sufficient to allow the incubator doors to be closed.

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
Golden Hour protocol
大体时间:12 months

To assess compliance with the "Golden Hour" protocol's target timeframe, defined as achieving full stabilization of the preterm newborn within the first 60 minutes of life.

12 months

次要结果测量

结果测量
措施说明
大体时间
Neonatal individual factors associated with treatment failure
大体时间:12 months

Compilation of individual neonatal factors (gestational age, birth weight, time from birth to care, circumstances of birth, care in the delivery room).

12 months
Organizational factors related to childbirth associated with protocol failure
大体时间:12 months

Compilation of organizational factors related to childbirth (experience of the medical and paramedical staff, the team's workload at the time of delivery, and whether the birth occurred during an on-call shift)

12 months
Acceptance of the protocol by the teams
大体时间:12 months

Satisfaction survey completed by the external evaluator, the physician, and the nurse in charge of the patient.

12 months
Effectiveness of the Golden Hour protocol at one hour of life
大体时间:12 months

Recording of temperature (in celsius degrees) at 1 hour of life in accordance with the department's current protocol.

12 months
Effectiveness of the Golden Hour protocol at two hours of life
大体时间:12 months

Recording of blood glucose (in g/L) at 2 hours of life in accordance with the department's current protocol.

12 months

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。

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 (估计的)

2026年10月1日

初级完成 (估计的)

2027年10月1日

研究完成 (估计的)

2027年10月1日

研究注册日期

首次提交

2026年9月14日

首先提交符合 QC 标准的

2026年9月14日

首次发布 (实际的)

2026年9月21日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月14日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

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

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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