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临床试验/NCT05806684
NCT05806684尚未招募不适用

Correlation Between Hyperbilirubinemia and Retinopathy of Prematurity in Preterm Infants of Very Low Birth Weight and Less Than 32 Weeks Gestational Age: a Retrospective Study

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico1 个研究点 分布在 1 个国家目标入组 1,586 人开始时间: 2023年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,586
试验地点
1
主要终点
Number of subjects who developed Retinopathy of Prematurity (ROP) (divided by severity)

研究概览

简要总结

The goal of this retrospective observational study is to [learn about the correlation between hyperbilirubinemia and retinopathy of prematurity in preterm infants.

The main question it aims to answer are:

• To evaluate the possible effect of neonatal jaundice linked to the presumed protective antioxidant action of bilirubin on the development of ROP, compared to a control group which, although presenting ROP, did not develop jaundice.

详细描述

Retinopathy of prematurity (ROP) is a disease related to prematurity with a multifactorial and only partially known etiopathogenesis.

A better understanding of its risk factors and potential protective factors may lead to the development of better preventive and therapeutic strategies in the future and, thus, ultimately, reduce the incidence of this pathology.

The starting hypothesis of our study is based on the proven physiological antioxidant effect of bilirubin, demonstrated by various in vitro and in vivo studies: it was hypothesized that bilirubin, by its antioxidant action, could exercise a protective role against oxidative stress pathologies typical of prematurity, including ROP.

However, the antioxidant action of bilirubin in humans, particularly newborns, is still controversial. Some studies have demonstrated a role protective of bilirubin against oxidative damage in preterm infants, while others have conversely observed that hyperbilirubinemia is a risk factor for ROP.

It has been hypothesized that bilirubin exerts its antioxidant effect only under conditions of increased oxidative stress, i.e., when the remaining antioxidant mechanisms are no longer sufficient to cope with the production of highly reactive molecules, for example, under conditions of hypoxia and hyperoxia.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Gestational age < 32 weeks
  • birth weight < 1500g

排除标准

  • lack of data regarding the development of ROP
  • lack of data on the development of jaundice.

结局指标

主要结局

Number of subjects who developed Retinopathy of Prematurity (ROP) (divided by severity)

时间窗: between 01/01/2010 and 12/31/2020

Retinopathy of Prematurity (ROP)

Number of subjects who developed jaundice

时间窗: between 01/01/2010 and 12/31/2020

Jaundice

Duration of jaundice (days) for each subject

时间窗: between 01/01/2010 and 12/31/2020

Days of jaundice

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giacomo Cavallaro

Principal Investigator

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

研究点 (1)

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