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临床试验/NCT05621785
NCT05621785Enrolling By Invitation不适用

The Effect of Postnatal Corticosteroid Use on Lung Ultrasonography Scores in Preventing the Development of Bronchopulmonary Dysplasia in Premature Infants

Kırıkkale University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
30
试验地点
1
主要终点
Bronkopulmoner Displazi under the corticosteroid

研究概览

简要总结

Bronchopulmonary dysplasia (BPD) is one of the most common morbidities in premature infants and is associated with poor neurodevelopmental outcomes . Although mechanical ventilation and oxygen requirements in premature infants have been identified as triggering mechanisms for the development of inflammation and BPD over time, data now support that a number of perinatal events that may stimulate the inflammatory cascade before birth also have important effects. Corticosteroids such as dexamethasone and hydrocortisone have proven to be beneficial for the prevention and management of postpartum BPD due to their anti-inflammatory properties . With this study, the effects of corticosteroid use on lung ultrasound findings in BPD will be investigated, and acute and chronic lung ultrasonography scores will be recorded. A prospective observational study was planned in the neonatal intensive care unit between 2022 and 2024 in premature infants below 32 weeks of gestational age. Demographic data and Lung Ultrasonography findings of these babies will be recorded. Among the patients who are predicted to go to BPD, in the group using corticosteroids, Lung Ultrasonographic imaging will be performed and the effect of corticosteroids on pulmonary findings will be recorded. It is planned to investigate whether postnatal steroid use has an effect on lung ultrasound findings in preterm infants with BPD.

详细描述

It is aimed to show the changes in lung ultrasound findings before, during and after steroid use in premature newborn babies born under 32/7 weeks. Thus, detailed new information will be obtained about the role and importance of corticosteroids in preventing the progression to BPD.

Postnatal corticosteroids are not routinely used to prevent BPD in our unit in our hospital. However, if premature babies meet the following criteria, postnatal low-dose corticosteroids are administered.

In the postnatal third week;

  1. Premature infants who are still not weaned from invasive mechanical ventilation.
  2. Those who continue to need non-invasive positive pressure ventilation
  3. Those who need more than 50% oxygen

Applied steroid protocols:

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Those who were born in Kırıkkale University Faculty of Medicine Hospital or who were born in other hospitals and were admitted to Kırıkkale University Faculty of Medicine Neonatal Intensive Care Unit within the first 48 hours of life.
  • Gestational age below 32/7 weeks
  • Those who will be administered postnatal corticosteroids with the decision of the consultant by meeting the diagnostic criteria for going to BPD
  • Informed consent was obtained from the family

排除标准

  • Those with cyanotic congenital heart disease
  • Those with lung and thorax malformations,
  • Those with major congenital anomalies
  • Newborns who do not meet the criteria for postnatal corticosteroid therapy or who are not given postnatal corticosteroids by the consultant
  • The family's refusal to give informed consent

结局指标

主要结局

Bronkopulmoner Displazi under the corticosteroid

时间窗: 2 years

Although the use of corticosteroids in the course of BPD has a positive effect on lung ultrasound findings in the acute period in premature newborn babies, long-term beneficial effects cannot be observed.

次要结局

未报告次要终点

研究者

发起方
Kırıkkale University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sevde Nur Vural

Asistant Doctor

Kırıkkale University

研究点 (1)

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