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临床试验/NCT01780155
NCT01780155已完成不适用

Candidate Genes Associated With Susceptibility to Bronchopulmonary Dysplasia and Retinopathy of Prematurity

National Institute of Environmental Health Sciences (NIEHS)8 个研究点 分布在 2 个国家目标入组 1,068 人开始时间: 2013年6月24日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,068
试验地点
8
主要终点
Bronchopulmonary dysplasia; retinopathy of prematurity

研究概览

简要总结

Background:

  • Some premature babies develop bronchopulmonary dysplasia (BPD) and retinopathy of prematurity (ROP). BPD and ROP are long-term chronic diseases of the lungs and eyes, respectively. BPD is associated with receiving mechanical ventilation to treat respiratory distress syndrome, and causes lung inflammation and scarring. ROP is caused by poor development of blood vessels in the eyes, and may lead to blindness. Because not all premature babies develop BPD or ROP, researchers want to study the genes that could be associated with these diseases. They will look at both premature infants and their parents to see if there is a genetic component to BPD and ROP.

Objectives:

  • To study genes that may be associated with BPD and ROP.

Eligibility:

  • Premature babies born with a weight less than or equal to 1,250 grams.
  • Parents of the premature babies.

Design:

  • Parents will answer questions about the mother s health and pregnancy.
  • Delivery and medical information will be collected during the baby s hospitalization for the first month after birth.
  • Parents will provide a saliva sample from the inside of the cheek.
  • A saliva sample will also be collected from the baby within 28 days of birth. If the baby needs tracheal aspiration (removal of fluid from the throat), tracheal fluid samples will also be collected.
  • Parents will have followup interviews about their child s health 6 months, 12 months, and yearly for up to 6 years after birth.
  • This is a genetic study only. Treatment will not be provided as part of this study.

详细描述

Understanding the role of susceptibility genes for risk of BPD and ROP may lead to immediate identification of populations who require personalized medical care, and to the assessment of innovative prophylactic and therapeutic interventions in the future. Our purpose is to establish in our hospital network a prospective cohort of triads composed of premature newborns with a birth weight less than or equal to 1250 g and their parents, to examine the role of candidate susceptibility genes in the development of BPD and ROP. Our hypothesis is that the presence of single-nucleotide polymorphisms in candidate genes is associated with differential susceptibility to BPD and ROP. As an initial model, a loss-of-function substitution at position -617 of the NRF2 promoter region is hypothesized to be associated with a greater risk of severe BPD and prethreshold ROP in premature infants with a birth weight less than or equal to 1250 g.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Bronchopulmonary dysplasia; retinopathy of prematurity

时间窗: 6 years

次要结局

未报告次要终点

研究者

发起方
National Institute of Environmental Health Sciences (NIEHS)
申办方类型
Nih
责任方
Sponsor

研究点 (8)

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