NL-OMON37174
已完成
3 期
A MULTI-CENTRE, RANDOMIZED, PLACEBO-CONTROLLED, DOUBLE-BLIND, TWO-ARMED, PARALLEL GROUP STUDY TO EVALUATE EFFICACY AND SAFETY OF IV SILDENAFIL IN THE TREATMENT OF NEONATES WITH PERSISTENT PULMONARY HYPERTENSION OF THE NEWBORN (PPHN) OR HYPOXIC RESPIRATORY FAILURE AND AT RISK FOR PPHN, WITH A LONG TERM FOLLOW-UP INVESTIGATION OF DEVELOPMENTAL PROGRESS 12 AND 24 MONTHS AFTER COMPLETION OF STUDY TREATMENT - A1481316 (207824)
概览
- 阶段
- 3 期
- 干预措施
- 未指定
- 疾病 / 适应症
- Aanhoudende pulmonale hypertensie van de pasgeborene (PPHN)
- 发起方
- Pfizer
- 入组人数
- 5
- 状态
- 已完成
- 最后更新
- 2年前
概览
简要总结
Trial is onging in other countries
研究者
入排标准
入选标准
- •Subject eligibility should be reviewed and documented by an appropriately qualified member of the investigator\*s study team before subjects are included in the study.
- •Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the study:
- •1\. PPHN or hypoxic respiratory failure (HRF) at risk for PPHN associated with:
- •\* Idiopathic PPHN;
- •\* Meconium aspiration syndrome;
- •\* Sepsis; or
- •\* Pneumonia.
- •2\. \*72 hours of age and \*34 weeks of gestation at screening.
- •3\. OI \>15 and \<60, calculated using two blood gases taken at least 30 minutes apart prior to randomization and start of study drug infusion.
- •4\. Concurrent treatment with iNO at 10\-20 ppm on \*50% oxygen.
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1\. Prior or immediate need for ECMO or CPR.
- •2\. Expected duration of mechanical ventilation of less than 48 hours.
- •3\. Life\-threatening or lethal congenital anomaly.
- •4\. Profound hypoxemia: PaO2 \<30 mm Hg on any arterial blood gas drawn within 30 minutes of starting study drug infusion.
- •5\. Severe hypotension at baseline (mean arterial pressure (MAP) \<30 mmHg) not responsive to medical management, or shock any time during screening.
- •6\. Significant congenital heart disease or defect exclusive of inter\-atrial communication or patent ductus arteriosus.
- •7\. Large left to right intracardiac or ductal shunting (diagnosed from echocardiogram within 24 hours of admission).
- •8\. Large clinically significant intracranial bleed (diagnosed from cranial ultrasound within 24 hours of admission).
- •9\. Lung hypoplasia syndromes diagnosed on the basis of prolonged oligohydramnios or hydrops faetalis.
结局指标
主要结局
未指定
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