Preliminary Percutaneous Intervention Versus Observational Trial of Arterial Ductus in Low-weight Infants (PIVOTAL)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Time on Ventilatory Support Required
研究概览
简要总结
This is a pilot study to collect preliminary data for a larger, multicenter clinical trial proposal. The study will examine two strategies commonly used to treat preterm infants diagnosed with a patent ductus arteriosus (PDA). The PDA closes after birth for most term infants, but in many preterm infants, it remains open (patent). A PDA may present a complication for a number of short-term problems faced by preterm infants. Longer-term issues include the development of pulmonary hypertension and changes in the size and performance of the heart. There is ongoing debate as to whether or not the PDA requires intervention.
详细描述
Preterm infants diagnosed with a hemodynamically-significant patent ductus arteriosus (HSPDA) will be included. Specific criteria will be followed to determine if a patent ductus arteriosus (PDA) is "hemodynamically significant". Infants will be randomized to two different approaches for management of the PDA. The first will be catheter-based closure (intervention) and the second will be conservative management (non-intervention). Both procedures are standard practice at many institutions, including Nationwide Children's Hospital. Infants randomized to receive intervention will undergo a procedure in which a catheter is used to place an FDA-approved device within the PDA, to close it (like a plug). Infants randomized to the conservative management (non-intervention) group will be permitted time to see if the PDA closes on its own, naturally. However, if the PDA remains open and intervention is deemed medically necessary, they will also undergo the catheter closure procedure.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 14 Days 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Maximum age (above) indicates qualifying / eligibility criteria. Participating infants will be followed until they reach 36 weeks corrected gestational age OR are discharged from the hospital, whichever comes first.
- •Inclusion Criteria:
- •Preterm infants ≤28 weeks gestational age with hemodynamically-significant patent ductus arteriosus (PDA) at 2 - 4 weeks of age.
- •Body weight greater than or equal to 700 grams
排除标准
- •Significant genetic (ex.- Trisomy) or physiological (ex. - Omphalocele) abnormalities
- •Other cardiac disease NOT INCLUDING atrial-septal defects or ventricular septal defects (ex. Tetrology of Fallot, Single ventricle physiology)
- •Body weight less than 700 grams
研究组 & 干预措施
Catheter-closure of PDA
Infants randomized to this group will undergo a catheter procedure to close hemodynamically-significant patent ductus arteriosus (HSPDA).
干预措施: Cather closure of patent ductus arteriosus (PDA) (Device)
Conservative management of PDA
Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.
干预措施: Cather closure of patent ductus arteriosus (PDA) (Device)
Conservative management of PDA
Infants randomized to this group will be treated to reduce the symptoms of a hemodynamically-significant patent ductus arteriosus (HSPDA), in the hopes that over time the HSPDA will become reduced in size (to the point of no longer meeting criteria for being "hemodynamically significant") or close naturally. Infants in this group with declining health status attributable to a PDA which meet qualifying criteria may receive catheter closure (intervention) if deemed medically necessary.
干预措施: Conservative management of patent ductus arteriosus (PDA) (Other)
结局指标
主要结局
Time on Ventilatory Support Required
时间窗: Weekly for 1 month pre-closure (intervention group) or corresponding time point (non-intervention group); Weekly for 1 month post-closure (intervention group) or corresponding time point (non-intervention group); 36 weeks corrected gestational age
Period the participant is in need of ventilator support \[Synchronized Intermittent Mandatory Ventilation (SIMV), High Frequency Oscillatory Ventilation (HFOV), or similar\]
Supplemental Oxygen Need
时间窗: Post-randomization (up to 6 weeks) for participants in both groups.
Weekly supplemental oxygen support required (in % fraction of inspired oxygen, FiO2)
次要结局
- Number of Subjects Requiring Catheter-based Closure Due to Failed Conservative Management (Applies to Conservative Management Group Only)(6 weeks post-randomization (to conservative management group))
研究者
Carl Backes, MD
Physician, Neonatology
Nationwide Children's Hospital