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临床试验/NCT01722760
NCT01722760已完成不适用

AD-ON: The Danish Study on Tidal Neonatal Nitrogen Oxide (NO) and Vitamins A and D as Possible Predictors of BPD

Hillerod Hospital, Denmark2 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2013年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
1,500
试验地点
2
主要终点
Tidal exhaled Nitrogen Oxide

研究概览

简要总结

Children born prematurely are of greater risk of developing chronic lung disease (Bronchopulmonary Dysplasia).

With an increase in the amount of premature children, we expect an increasing number of children with BPD.

Today we do not have many ways of predicting or treating this condition, and the children are usually in hospital for several months after birth. Many are dismissed with home oxygen. Children with BPD are typically often re-submitted to hospital with respiratory disease the first couple of years, and some of them have problems throughout childhood and into adulthood.

Other scientists have found a correlation between BPD and Chronic Obstructive Pulmonary Disease (COPD).

The condition as well as the treatment (steroids), are associated with great risk of adverse effects as Cerebral Palsy, blindness, deafness and mental retardation.

The investigators wish to find a safe way to identify the children in greater risk of developing BPD, who could therefore benefit from a more intensive treatment.An early diagnosis would increase the possibility of predicting the prognosis.

Other studies have proven a connection between both low vitamin A and D and high exhaled nitrogen oxide (NO) with lung disease.

With this trial the investigators wish to make a reference material for NO and vitamins A and D in infants admitted to the neonatal department at two hospitals in Denmark, both with and without treatment with nasal Continuous Positive Airway Pressure.

The investigators furthermore wish to describe an eventual connection between BPD and these factors by examining a large group of children on 7 specific occasions within the first two months of life and at a one year follow up.

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 2 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Cohort inclusion - All term and preterm infants admitted to Neonatal (Intensive) Care Unit. Gestational Age 24-42 weeks.

排除标准

  • Children with ciliary dyskinesia, as NO is distinguishable lower in these children.
  • Children who can not cooperate to the examination.
  • Children so dependant on oxygen, that the examination/measurement is not possible.
  • Children with pneumothorax
  • Children having a diagnosed pneumonia verified by tracheal secrete.
  • Children with bigger congenital anomalies

结局指标

主要结局

Tidal exhaled Nitrogen Oxide

时间窗: 6-7 measures within the first 2 months of life and at 1 year of age.

Reference material of tidal expiratory NO in a cohort of neonates admitted to Neonatal Intensive Care Unit and Neonatal Care Unit will be made. All children in the study will be measured on 8 occasions including a one year follow up. Association with Bronchopulmonary Dysplasia (BPD) and the measures above will be noted.

次要结局

  • Vitamin levels(From birth to a one year follow up)

研究者

发起方
Hillerod Hospital, Denmark
申办方类型
Other
责任方
Principal Investigator
主要研究者

Birgitte Johanne Schmidt

MD

Hillerod Hospital, Denmark

研究点 (2)

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