The Effectiveness of Vardenafil Vs Sildenafil for The Treatment of Pulmonary Hypertension of the Newborn
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Pulmonary Hypertension
研究概览
简要总结
The goal of this clinical trial is to learn if drug Vardenafil works to treat pulmonary hypertension in newborns, It will also learn about the safety of Vardenafil. The main questions it aims to answer are:
Does Vardenafil lower the pulmonary hypertension in newborns? What medical problems do participants have when taking Vardenafil? Researchers will compare drug Vardenafil to drug Sildenafil to see if drug Vardenafil works better to treat pulmonary hypertension.
Participants will be divided into 2 groups , one group will take oral drug: Vardenafil and the other group will take oral drug: Sildenafil every day.
Pulmonary hypertension will be measured daily until it returns to normal. Keep a diary of the symptoms and any complications
详细描述
A double blind controlled trial in Children's Hospital Damascus between 5/2023 and 9/2024 on newborns up to 4 d old diagnosed with PPHN, patients were allocated randomly into one of the 2 arms of the study, group Sildenafil and group Vardenafil, both medicines administered orally, management of the patients was the same in both groups except for the investigated drug, pulmonary hypertension and resistance were measured by echo at diagnosis time and every 24 hours later on till normalization of pulmonary pressure, at the end of recruitment data was collected and analyzed to confirm the safety of Vardenafil and compare the efficacy of Vardenafil to Sildenafil
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 24 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestation age: 28 weeks or more
排除标准
- •Cardiac deformity, inability to administer the drug orally
研究组 & 干预措施
Vardenfil
Oral Vardenafil given q12h.
干预措施: Vardenafil (Drug)
Sildenafil
Oral Sildenafil given q6h.
干预措施: Sildenafil (Drug)
结局指标
主要结局
Pulmonary Hypertension
时间窗: Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.
Pulmonary Resistance
时间窗: Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio
次要结局
- Respiratory Distress(Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4))
- Death(From day 1 of treatment till discharge from NICU ( 3 days to 90 days))