Treatment of Delayed Pulmonary Transition in Extremely Preterm Infants & Bronchopulmonary Dysplasia
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AdventHealth
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Death
研究概览
简要总结
Inhaled nitric oxide (iNO) is an effective treatment for pulmonary hypertension (PH) in term and near-term infants. Preterm infants are at risk for early PH that is associated with high risk for bronchopulmonary dysplasia or death. In multiple clinical trials, iNO treatment was not effective for BPD prevention. However, infants were not screened for PH and iNO treatment was not targeted for PH. iNO treatment for PH in preterm infants is controversial due to lack of evidence. The study team hypothesizes that early diagnosis of PH (72-96 hours of life) and iNO treatment will decrease the incidence of death and bronchopulmonary dysplasia and improve oxygenation in extremely preterm infants.
- To determine if iNO treatment of extremely preterm infants with early pulmonary hypertension as established with echocardiographic evidence at 72-96 hours of age will decrease incidence of death or BPD.
- To determine if iNO treatment of extremely preterm infants with early PH will decrease the pulmonary artery pressure and improve oxygenation within 72 hours of intervention.
详细描述
This is a single center, blinded, randomized control clinical trial to evaluate the effects of inhaled nitric oxide on the outcome of survival and incidence of bronchopulmonary dysplasia. This trial has a planned enrollment of 138 infants with 68 infants with delayed pulmonary transition assigned to either the treatment or placebo group. There is no enrollment restriction based on gender, ethnicity, or race. Enrollment is expected to take 36 months with an additional 12 months for data analysis.Infants with early pulmonary hypertension will be randomized to the treatment or placebo group. Treatment will continue until resolution of pulmonary hypertension or through Day 14, whichever comes first. Serial echocardiograms will be performed every 48 hours +/-12 hours until Day 14. Oxygen saturation levels will be averaged every 24 hour period following enrollment. This study will provide evidence for the beneficial effects of early diagnosis and treatment of pulmonary hypertension in preterm infants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 23 Weeks 至 29 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Birth between 23 weeks and 0 days and 29 weeks and 6 days.
- •Positive pressure ventilation at 72-96 hours of age
- •Early pulmonary hypertension
排除标准
- •Death prior to 12 hours of age or first echocardiogram
- •Chromosomal anomalies
- •Major congenital anomalies
- •Myocardial dysfunction
- •Complex cardiac defect
- •Dependent on right to left shunting of blood
- •Excessive pulmonary blood flow (left to right shunt across PDA)
- •Pulmonary blood flow obstruction secondary to pulmonary vein stenosis
- •Mitral valve stenosis
- •Cor triata
- •Aortic valve atresia
研究组 & 干预措施
Treatment group - active
inhaled nitric oxide treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.
干预措施: inhaled nitric oxide (Drug)
Treatment group - placebo
Placebo treatment will start at 20 ppm and continue for 2 weeks or until resolution of pulmonary hypertension, whichever comes first.
干预措施: Placebo (Drug)
结局指标
主要结局
Death
时间窗: 36 weeks post menstrual age
Incidence of death
Bronchopulmonary (BPD) Dysplasia (Yes/no)
时间窗: 36 weeks post menstrual age
Incidence of bronchopulmonary dysplasia as determined by need for positive pressure ventilation or supplemental oxygen after room air challenge test
次要结局
- Pulmonary Hypertension(Duration of treatment or up to Day 14)