A Prospective, Open, Single-arm, Multi-center Phase IV Clinical Study of Inhaled Nitric Oxide Combined With Ventilatory Support for the Treatment of Neonatal (Gestational Age ≥34 Weeks) Hypoxic Respiratory Failure With Pulmonary Hypertension.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To evaluate the safety of inhaled nitric oxide combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.
研究概览
简要总结
This is a prospective, open-label, single-arm, multicenter Phase IV clinical study to evaluate the safety of INOmax for the treatment of hypoxic respiratory failure with pulmonary hypertension in newborns (≥ 34 weeks gestational age). To evaluate the safety of INOmax combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.
详细描述
The study treatment will be administered in ventilated newborn infants expected to require support > 24 hours, after respiratory support has been optimized. This includes optimizing tidal volume/pressures and lung recruitment (surfactant, high frequency ventilation, and positive end expiratory pressure).
The administration of the study drug will be supervised by a physician investigator experienced in neonatal intensive care and used in clinics where neonatal artificial ventilation as well as rescue and resuscitation are available.
The starting dose of INOmax is 20 ppm, which is controlled by the INOmax DSIR Plus delivery system in the respiratory circuit during mechanical ventilation. The dose will be maintained at 20 ppm for 4 hours after the start of administration, then the dose can be weaned to 5 ppm provided that the arterial oxygenation is adequate, as determined by the investigator within 4-24 hours of therapy, and the therapy should be maintained at 5 ppm until the fraction of inspired oxygen (FiO2) < 0.60.
The treatment will be maintained until the potential hypoxia is resolved, or the investigator determines that the neonate no longer needs to use this drug. The maintenance treatment time is usually less than 4 days (96 hours). If the oxygenation level has not improved significantly after 4 days of maintenance treatment, the suitability of the treatment plan should be reassessed. If it is necessary to continue using this drug after evaluation by the investigator, the maximum administration time should not exceed 14 days.
Doses greater than 20 ppm are not allowed. Monitoring
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 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates ≥ 34 weeks gestation age.
- •Hypoxic respiratory failure requiring more than 24 hours of ventilatory support.
- •Clinical or echocardiographic evidence of pulmonary hypertension (systolic pulmonary arterial pressure [sPAP] > 35 mm Hg or > 2/3 systemic blood pressure [SBP] or there is a right-to-left shunt at the atrium or arterial ductus).
- •Age less than 7 days at the time of treatment initiation with study drug.
- •The neonatal guardian agrees to participate in the study and signs an informed consent form (ICF).
排除标准
- •Neonates dependent on right-to-left shunting of blood.
- •Neonates whose mother has been treated with anticoagulant therapies during pregnancy.
- •Echocardiography confirmed left-to-right shunt or left ventricular dysfunction.
- •ECMO is urgently needed, or neonate has received ECMO.
- •Patient is at risk of imminent death (death expected within 24 hours).
- •Life-threatening abnormality (cranial, cardiac, thoracic).
- •Chromosomal abnormality.
- •Congenital diaphragmatic hernia
- •Congenital heart defect (other than patent ductus arteriosus or small atrial septal defect).
- •Neonate has been resuscitated requiring chest compressions within 6 hours of study treatment start.
- •Significant bleeding diathesis such as grade IV intraventricular hemorrhage or periventricular leukomalacia, pulmonary hemorrhage, uncontrolled bleeding or hemodynamic failure.
- •Disseminated intravascular coagulopathy.
- •Active seizures while receiving anticonvulsants.
- •Experienced prolong asphyxia with evidence of severe acidosis (pH<7.25)
- •Receiving nitric oxide donor agents such as prilocaine, sodium nitroprusside, nitroglycerin, and sulfonamides.
- •Other subjects determined by the investigator to be unsuitable for inclusion.
研究组 & 干预措施
inhaled nitric oxide combined with ventilatory support
干预措施: Inhaled nitric oxide (NO) (Drug)
结局指标
主要结局
To evaluate the safety of inhaled nitric oxide combined with ventilatory support in the treatment of neonatal (≥ 34 weeks gestational age) hypoxic respiratory failure with pulmonary hypertension.
时间窗: Adverse events that occured during the study, not more than 14 days. Blood routine, blood biochemistry, blood gas analysis, chest X-ray and echocardiography will be performed at the screening and through study completion, not more than 14 days.
Incidence and severity of all treatment emergent adverse events (TEAEs). Incidence of drug-related serious AEs (SAEs). Incidence of AEs of special interest (AESI).
次要结局
未报告次要终点