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临床试验/NCT07822750
NCT07822750尚未招募不适用

Predictors of Outcomes in Pulmonary Hypertension of the Newborn

Assiut University0 个研究点目标入组 60 人开始时间: 2026年9月10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
60
主要终点
In-hospital mortality

研究概览

简要总结

This prospective cohort study aims to identify the clinical, laboratory, and echocardiographic predictors of outcomes among neonates diagnosed with persistent pulmonary hypertension of the newborn at Assiut University Children Hospital.

详细描述

Persistent pulmonary hypertension of the newborn (PPHN) is a serious condition characterized by failure of the normal postnatal decline in pulmonary vascular resistance, leading to severe hypoxemia. Outcomes vary widely, ranging from complete recovery to death.

This observational study will include term and preterm neonates admitted to the NICU with clinical and echocardiographic evidence of pulmonary hypertension. Clinical, laboratory, and echocardiographic parameters will be recorded to identify predictors of mortality and other adverse outcomes.

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 28 Days(Child)
性别
All
接受健康志愿者

入选标准

  • - Neonates (term and preterm) admitted to the NICU
  • Clinical and echocardiographic evidence of pulmonary hypertension
  • Written informed consent from parents or legal guardians

排除标准

  • - Major structural cyanotic congenital heart disease
  • Lethal congenital anomalies or chromosomal abnormalities incompatible with survival

研究组 & 干预措施

Single cohort: Neonates with PPHN

Term and preterm neonates with clinical and echocardiographic evidence of persistent pulmonary hypertension who will be followed for clinical, laboratory, and echocardiographic predictors of outcome.

结局指标

主要结局

In-hospital mortality

时间窗: Up to 30 days

Proportion of neonates with persistent pulmonary hypertension who die before hospital discharge.

次要结局

  • Duration of mechanical ventilation(Up to 30 days)
  • Duration of oxygen therapy(Up to 30 days)
  • Use of sildenafil(Up to 30 days)
  • Use of inotropes(Up to 30 days)
  • Duration of NICU stay(Up to 30 days)
  • Time to echocardiographic resolution(Up to 30 days)

研究者

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

Aya Saleh Mohammed

Resident Physician

Assiut University

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