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临床试验/NCT05082272
NCT05082272已完成不适用

Pulmoner Hipertansiyon gelişmiş Bronkopulmoner Displazili Pretermlerin Ekokardiyografik ve Biyokimyasal değerIendirilmesi

Kayseri City Hospital0 个研究点目标入组 59 人开始时间: 2016年1月1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
59
主要终点
Serum kallistatin level

研究概览

简要总结

Pulmonary hypertension may develop in premature newborn infants due to impaired lung development. The diagnosis of this disease can actually be made with interventional methods.

In this study, we evaluated the importance of echocardiographic examination and blood laboratory tests in diagnosing this disease.

详细描述

Bronchopulmonary dysplasia diagnosis was done by the same neonatologist according to the criteria published by the American National Institutes of Health (NIH) in 2001.

Demographic data of patients like: birth weight, gender, gestational age; neonatal morbidity like: surfactant administration, PDA and its treatment, duration of mechanical ventilation, diuretic usage, intraventricular hemorrhage and its grade, necrotizing enterocolitis (NEC) and its severity, any surgical procedures and late-onset sepsis were recorded.

Moreover; maternal and perinatal risk factors like presence of chorioamnionitis, maternal hypertension and administration of antenatal steroids were also recorded.

Echocardiography:

Echocardiographic measurements were performed with a GE Vivid-7 pro equipped with a 3-7 MHz for 2-dimensional and color flow Doppler mapping by the same pediatric cardiologist.

研究设计

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

入排标准

年龄范围
28 Days 至 3 Months(Child)
性别
All
接受健康志愿者

入选标准

  • Born ≤ 28 postmenstrual weeks
  • Respiratory support persisting at 36 weeks corrected postmenstrual age.
  • Echocardiographic examination consistent with pulmonary hypertension
  • BPD patients without PHT
  • Inclusion Criteria:
  • Born ≤ 28 postmenstrual weeks
  • Respiratory support persisting at 36 weeks corrected postmenstrual age.
  • Normal echocardiographic examination
  • Healty preterms
  • Born ≤ 28 postmenstrual weeks
  • Do not need respiratory support persisting at 36 weeks corrected postmenstrual age
  • Normal echocardiographic examination

排除标准

  • Congenital heart disease (with the exception of patent ductus arteriosus or patent foramen ovale)
  • Structural lung and airway malformations (including tracheobrochomalacia)
  • Congenital diaphragmatic hernia
  • Chromosome abnormality

结局指标

主要结局

Serum kallistatin level

时间窗: 1 month

Serum kallistatin level is effective in diagnosing pulmonary hypertension in preterms with bronchopulmonary dysplasia and is consistent with the clinical findings of the patients.

Echocardiographic examination

时间窗: 1 month

Echocardiographic examination is effective in diagnosing pulmonary hypertension in preterms with bronchopulmonary dysplasia and is consistent with the clinical findings of the patients.

次要结局

未报告次要终点

研究者

发起方
Kayseri City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

süleyman sunkak

Specialist (pediatric cardiolog)

Kayseri City Hospital

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