Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low Weight Infants
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 48
- 主要终点
- Number of days free of ventilatory support requirement (ventilator-free days; VFDs)
研究概览
简要总结
Patent Ductus Arteriosus is a developmental condition commonly observed among preterm infants. It is a condition where the opening between the two major blood vessels leading from the heart fail to close after birth. In the womb, the opening (ductus arteriosus) is the normal part of the circulatory system of the baby, but is expected to close at full term birth. If the opening is tiny, the condition can be self-limiting. If not, medications/surgery are options for treatment.
There are two ways to treat patent ductus arteriosus - one is through closure of the opening with an FDA approved device called PICCOLO, the other is through supportive management (medications). No randomized controlled trials have been done previously to see if one of better than the other. Through our PIVOTAL study, the investigators aim to determine is one is indeed better than the other - if it is found that the percutaneous closure with PICCOLO is better, then it would immediately lead to a new standard of care. If not, then the investigators avoid an invasive costly procedure going forward.
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
- None
入排标准
- 年龄范围
- 7 Days 至 32 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •EPIs born between 22-weeks+0 days (220/7 wks) and 27-weeks+6 days (276/7 wks) gestation, inclusive
- •Admitted to a study NICU
- •Birth weight ≥700-grams
- •Mechanically ventilated at time of consent and randomization
- •HSPDA ("PDA Score" ≥6) noted on echocardiogram (ECHO)
- •Randomization is able to be performed within 5 days of the qualifying ECHO and when infant is 7-32 days postnatal
排除标准
- •Clinical Exclusion Criteria
- •Life-threatening congenital defects (including congenital heart disease such as aortic coarctation or pulmonary artery stenosis). PDA and small atrial/ventricular septal defects are permitted;
- •Congenital lung abnormalities, (e.g. restrictive lung disease);
- •Pharyngeal or airway anomalies (tracheal stenosis, choanal atresia);
- •Treatment for acute abdominal process (e.g., necrotizing enterocolitis);
- •Infants with planned surgery;
- •Active infection requiring treatment;
- •Chromosomal defects (e.g., Trisomy 18);
- •Neuromuscular disorders;
- •Infants whose parents have chosen to allow natural death (do not resuscitate order) or for whom limitation of intensive care treatment is being considered (e.g. severe intraventricular hemorrhage)
- •Physician deems that the infant would not be a Percutaneous PDA Closure candidate due to clinical instability; however, if the infant's clinical status improves before 30-days postnatal and all inclusion criteria are still met, then the infant may be enrolled.
- •ECHO-based Exclusion Criteria
- •Pulmonary hypertension (defined by ductal right to left shunting for >33% of the cardiac cycle) in which early PDA closure may increase right ventricular afterload and compromise pulmonary and systemic blood flow;
- •Evidence of cardiac thrombus that might interfere with device placement;
- •PDA diameter larger than 4 mm at the narrowest portion (consistent with FDA-approved instructions for Piccolo™ device use).
- •PDA length smaller than 3 mm (consistent with FDA-approved instructions for Piccolo™ device use).
- •PDA that does not meet inclusion requirements ("PDA Score" <6).* * If a potential participant is found to have a PDA meeting eligibility requirements on a subsequent ECHO during the required period of 7 - 30 postnatal days of age, they may then be declared eligible to participate and enrolled, provided all other inclusion criteria are met and exclusion criteria are not met.
- •Other Exclusion Criteria
- •Parents or legal guardian do not speak English or Spanish
结局指标
主要结局
Number of days free of ventilatory support requirement (ventilator-free days; VFDs)
时间窗: 30 days post-randomization
Ventilator free days (VFDs) are defined as the number of days that a subject is alive and free from mechanical ventilatory support. VFDs are an established respiratory outcome measure in pediatric clinical trials, and are a strong predictor of short-term and longer-term oucomes, including length of neonatal intensive care unit (NICU) stay, morbidities, and mortality.
次要结局
- Diagnosis of cardiac dysfunction(36 weeks post-menstrual age)
- Abnormal cardiac remodeling(36 weeks post-menstrual age)
- Infant/Toddler Sensory Profile (Low Registration Domain)(3 - 4 months of corrected age)
- Infant/Toddler Sensory Profile (Low Threshold Domain)(3 - 4 months of corrected age)
- Total days on mechanical ventilation(4 months corrected age)
- Days on supplemental oxygen(Randomization through 4 months corrected age)
- Need for rescue intervention(Randomization through 4 months corrected age)
- Diagnosis of pulmonary hypertension or death(36 weeks post-menstrual age)
- Time to death(Randomization through 4 months corrected age)
- Hammersmith Neonatal Neurological Examination (HNNE)(34 - 36 weeks post-menstrual age)
- Hammersmith Infant Neurological Examination (HINE)(3 - 4 months of corrected age)
- Infant/Toddler Sensory Profile (Sensation Avoiding Domain)(3 - 4 months of corrected age)
- Type and incidence of serious adverse event(3 - 4 months of corrected age)
- Positive-pressure dependency or death(36 weeks post-menstrual age)
- Days requiring positive-pressure assisted breathing(Randomization through 4 months corrected age)
- General Movements Assessment (GMA)(34 - 36 weeks post-menstrual age)
- Infant/Toddler Sensory Profile (Sensory Sensitivity Domain)(3 - 4 months of corrected age)
- Type and incidence of any adverse event(3 - 4 months of corrected age)
- Infant/Toddler Sensory Profile (Sensation Seeking Domain)(3 - 4 months of corrected age)
- Baby Care Questionnaire (BCQ)(3 - 4 months of corrected age)
- Mother-Infant Bonding Scale (MIBS)(3 - 4 months of corrected age)
研究者
Carl Backes, MD
Professor of Pediatrics, Departments of Neonatology and Cardiology
Nationwide Children's Hospital