Effect of Early iNO on Oxidative Stress, Vascular Tone and Inflammation in Term and Late-Preterm Infants With Hypoxic Respiratory Failure
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Biomarkers of oxidative injury.
研究概览
简要总结
The investigators in this study are concerned about the harmful effects of oxygen exposure in newborn infants, particularly at high concentrations. Inhaled nitric oxide (iNO) is an FDA approved drug for the treatment of hypoxic respiratory failure (HRF) in term and late-preterm babies greater than 34 weeks gestation. Hypoxic respiratory failure occurs when a patient's lungs cannot get enough oxygen into their bloodstream. This condition is traditionally treated with high concentrations of oxygen and most often requires the patient be placed on a ventilator (breathing machine). The administration of inhaled nitric oxygen directly into the lungs often improves blood oxygen levels and allows caretakers to reduce the amount of oxygen given to the baby. The purpose of this research study is to evaluate if giving the inhaled nitric oxide earlier in the course of disease improves the effectiveness of the drug, reduces the amount of cellular injury from oxygen exposure, and decreases the total amount of time a patient requires supplemental oxygen. This study uses an FDA approved drug in a new manner.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 30 Minutes 至 48 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age ≥ 35 weeks gestation
- •Age of life ≤ 48 hours
- •Diagnosis of hypoxic respiratory failure (HRF) as defined by a post-ductal SaO2 ≤90% in ≥50% oxygen with a PEEP of ≥ 6cm or an oxygenation index (OI) ≥ 10 but ≤ 15 when mean airway pressure and PaO2 are known.
- •Mothers (ages 18 - 65) of eligible subjects for additional data collection
排除标准
- •Gestational age < 35 weeks gestation.
- •Post-natal age > 48 hours.
- •Previous treatment with 100% oxygen for longer than 4 hours.
- •Confirmed congenital diaphragmatic hernia.
- •Suspected or confirmed congenital airway or pulmonary anomaly.
- •Suspected or confirmed chromosomal anomaly or genetic aberration, with the exception of patients with trisomy 21 who do not have complex congenital heart disease.
- •Infants with pneumothorax as the primary cause of their HRF.
- •Infants with confirmed complex congenital heart disease.
研究组 & 干预措施
Early inhaled nitric oxide
Patients randomized to receive iNO at OI 10-15.
干预措施: Inhaled nitric oxide (Drug)
Bioinert inhaled gas (nitrogen gas)
Patients randomized to bioinert inhaled gas at OI 10-15.
干预措施: Nitrogen Gas (Drug)
Crossover iNO
Patients who deteriorate (OI >20 on two consecutive blood gases) will be unblinded. If they are receiving placebo gas, they will be started on iNO and make up the crossover cohort.
干预措施: Crossover iNO (Drug)
结局指标
主要结局
Biomarkers of oxidative injury.
时间窗: Urine samples will be collected upon enrollment and then at specific time points within the first 48 hours of study intervention to compare the change in biomarker concentrations from baseline up to hour 48.
Early administration of iNO to infants with HRF will result in reduced hyperoxia-mediated oxidative injury as measured by known biomarkers of oxygen free radical injury, including malondialdehyde and 8-hydroxy-2'-deoxyguanosine.
次要结局
- Responsiveness to study treatment.(Arterial oxygen concentration will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in arterial oxygen concentration from baseline up to hour 36.)
- Markers of inflammation.(Concentrations of pro and anti-inflammatory markers will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentrations from baseline up to hour 36.)
- Duration of oxygen treatment.(Participants will be followed for the duration of their hospital stay, with an expected average stay of 4 weeks.)
- Expression of endothelin-1.(Concentration of endothelin-1 will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36.)
- Expression of VEGF (vascular endothelial growth factor).(Concentration of VEGF will be measured upon enrollment and at specific time points in the first 36 hours of study intervention to compare the change in concentration from baseline up to hour 36.)