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临床试验/NCT04214795
NCT04214795Unknown不适用

The Effect of a Complete Course of Antenatal Steroids on Mortality and Morbidity of Preterm Infants

Hospital General Universitario Gregorio Marañon1 个研究点 分布在 1 个国家目标入组 710 人开始时间: 2012年1月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
710
试验地点
1
主要终点
Mortality

研究概览

简要总结

The aim is to evaluate the impact of a complete course of antenatal steroids treatment on mortality and main morbidities in a current population of preterm infants.

详细描述

All infants admitted in the Neonatal Department born with less than 32 weeks of gestational age are included.

Data are prospectively recorded. Perinatal variables (Gestational age, materna condition at admission, antenatal steroids treatment, gender and results of histological analysis of the placenta) are recorded as well as respiratory status during hospitalization and morbidities at discharge. Results of neurodevelopment test performed at 24 months of corrected age are also included.

研究设计

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

入排标准

年龄范围
— 至 6 Hours(Child)
性别
All
接受健康志愿者

入选标准

  • All infants admitted in the NICU (with less than 6 hours after birth) born with less than 32+0 weeks of gestational age (GA).

排除标准

  • Congenital malformations.
  • premature infants in whom active resuscitation measures are not established.

结局指标

主要结局

Mortality

时间窗: at hospital discharge, an average of 2-4 months.

次要结局

  • Number of participants with Bronchopulmonary dysplasia (BPD) diagnosis.(36 weeks postmenstrual age)
  • Number of participants requiring Surfactant administration(in the first 3 days after birth)
  • Number of participants that requires Mechanical ventilation.(during hospitalization, and average of 2-4 months)
  • Number of participants with Neurodevelopment disability(performed at 24 months)

研究者

发起方
Hospital General Universitario Gregorio Marañon
申办方类型
Other
责任方
Principal Investigator
主要研究者

Manuel Sanchez Luna

Medical Doctor. Pediatric Profesor

Hospital General Universitario Gregorio Marañon

研究点 (1)

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