跳至主要内容
临床试验/NCT06078618
NCT06078618已完成不适用

Place of Birth and Neonatal Health in Cases of Preterm Birth Between 32 and 36 Weeks of Amenorrhoea: a National Population-based Study

Centre Hospitalier Universitaire Dijon1 个研究点 分布在 1 个国家目标入组 240,000 人开始时间: 2022年1月1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
240,000
试验地点
1
主要终点
Neonatal morbidity rate

研究概览

简要总结

Moderate and late premature babies (32-36 weeks of amenorrhoea) account for around 6% of births, but 20% of neonatal deaths. These children also have an increased risk of neonatal morbidity and long-term neurodevelopmental sequelae compared with full-term newborns.

In the case of preterm birth, optimal antenatal, birth and postnatal management is necessary to prevent neonatal complications and mitigate longer-term consequences. However, we lack knowledge about the management of this at-risk population and the factors influencing their health.

This knowledge is needed in the current context of unfavourable trends in neonatal health. Over the last ten years, neonatal and infant mortality has stagnated in France, with France falling behind other European countries. According to the latest European report, France ranks 22nd out of 33 countries. The causes of this stagnation are not well known, but many hypotheses have been put forward, including sub-optimal organisation of care.

研究设计

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

入排标准

年龄范围
0 Days 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All mothers and their newborn babies (live or stillborn) who had a delivery stay between 32 and 36 days of age recorded in the PMSI between 01/01/2015 and 31/12/2020.

排除标准

  • Births in very small maternity units
  • Births in hospitals without an obstetrics unit
  • Births outside hospitals.

结局指标

主要结局

Neonatal morbidity rate

时间窗: up to 28 days after birth

Neonatal morbidity. Composite indicator of neonatal morbidity defined by 18 ICD 10 and/or CCAM diagnostic codes and including the following sub-categories: respiratory, infectious, neurological, metabolic pathologies and obstetric trauma.

Mortality rate

时间窗: up to 28 days after birth

Mortality (stillbirths, neonatal mortality before 28 days, hospital mortality)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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