NCT06679855招募中3 期
Milrinone for Prevention of Post-ligation Cardiac Syndrome Trial
NICHD Neonatal Research Network25 个研究点 分布在 1 个国家目标入组 316 人开始时间: 2025年6月13日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 316
- 试验地点
- 25
- 主要终点
- Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure
研究概览
简要总结
The goal of this Phase 3, randomized, masked clinical trial is to is to find out whether milrinone, when given to infants after PDA closure, will help the heart work better by supplying oxygen to the lungs and tissues.
The main questions it aims to answer are:
- to determine if milrinone decreases the risk of death or PLCS within 7 days of the procedure, compared to standard treatment; and
- to determine the effects of milrinone on two-year survival and neurodevelopmental outcome.
详细描述
Researchers will compare milrinone to a placebo saline solution to see if it helps the heart work better by supplying oxygen to the lungs and tissues.
After randomization the following will happen in both the control and treatment groups:
- Infant will start receiving either a low dose (0.33 μg/kg/min) of milrinone in the treatment group, OR saline solution in the control group through an intravenous (IV) line. The study drug will be started within 2 hours of the PDA closure procedure.
- For the first 2 to 4 hours, the study team will monitor very closely to see if there are any major side effects from the study drug.
- If the infant continues to have high blood pressure, which places an added stress on the heart, the dose will go up to 0.66 μg/kg/min. One more increase will be allowed to 0.75 μg/kg/min. The study drug will then stay at this dose. No more changes will happen to the dose. If there are side effects, then the study drug will be stopped and will not be started again.
- The study drug will be stopped after 24 hours if the infant only required the lowest drug and remains well. If the required higher doses of milrinone, it will take longer to wean them off the medication. Some infants may receive milrinone for 3-5 days. If the infant's heart starts to work better by using less oxygen from the breathing machine (ventilator), the study drug may be stopped before 3 days.
- Information will be collected from the infant's medical record including demographic information, gestational age, blood pressures, heart rates, respiratory rates, information about his or her breathing, medications, details of medical treatment for PDA, medical procedures including echocardiograms (ultrasound of the baby's heart), details of PDA closure (by surgery or transcatheter closure), head ultrasounds, and diagnoses. The investigators will also be collecting information from the maternal medical record including ultrasounds that may be relevant to the infant's course.
- Right after the study drug is stopped (which could be 5 days or less) the doctor may decide to give the infant the drug milrinone. This is a decision that will be made by the infant's doctor.
- After the infant goes home from the hospital, they will be scheduled for follow-up exams in the clinic. The follow-up visit will be done when the infant is about 2 years old. The visit will take about two hours to do. During the follow-up visit the investigators will test the infant's movement, behavior, and development. The investigators will also check the infant to make sure they do not have high blood pressure or any evidence of kidney disease.
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
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age at birth ≤27 weeks (and 6 days) and postnatal age < 3 months at intervention
- •Invasive or non-invasive positive pressure respiratory support (does not include low flow nasal cannula)
- •Hemodynamically significant PDA with minimum transductal diameter ≥1.0 mm within 2 days of intervention
- •Decision by clinical team to proceed with PDA closure via surgical ligation or percutaneous cardiac catheterization based on clinical and echocardiography features of hemodynamic significance.
排除标准
- •Any major congenital malformation
- •Congenital heart disease (except small (≤1mm) muscular ventricular septal defects, or small/moderate (<3mm) atrial septal defect)
- •Acute renal failure defined by urine output < 0.5 mL/kg/hour OR rise of serum creatinine by 0.3 mg/dL within 48 hours OR rise of serum creatinine more than 40% above baseline serum creatinine within prior 72 hours.
- •Systemic administration of vasodilator/inodilator agents
- •Prior history of arrhythmia
研究组 & 干预措施
Placebo
Placebo Comparator
An iv infusion of placebo (0.9% saline) of equivalent volume will be administered. The infusion will be accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes) to ensure blinding is maintained.
干预措施: Placebo infusion (Drug)
Milrinone
Active Comparator
An intravenous (iv) infusion of milrinone will be administered at an initial dose of 0.33 mcg/kg/min and accompanied by an iv bolus of 10 mL/kg of 0.9% NaCl (administered over 60 minutes).
干预措施: Milrinone infusion (Drug)
结局指标
主要结局
Post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure
时间窗: Onset within 48 hours but may last up to 7 days
Composite outcome of post-ligation cardiac syndrome (PLCS) or death within 7 days of PDA closure. Onset within 48 hours but may last up to 7 days.
次要结局
- Systemic hypotension(Onset within 48 hours but may last up to 7 days)
- Systemic hypertension(Onset within 48 hours but may last up to 7 days)
- Oxygenation failure(Onset within 48 hours but may last up to 7 days)
- Ventilation failure(Within 72 hours of PDA closure)
- Vasopressor score(Within 7 days of PDA closure)
- Use of open-label milrinone or systemic vasodilator after cessation of study drug administration(After study drug cessation and within 7 days of PDA closure)
- Time to successful extubation(36 weeks postmenstrual age)
- Post-intervention Moderate-severe bronchopulmonary dysplasia at 36 weeks' gestation(36 weeks postmenstrual age)
- Post-intervention Chronic Pulmonary hypertension(36 weeks postmenstrual age)
- Post-intervention Periventricular Leukomalacia (PVL)(36 weeks postmenstrual age)
- Post-intervention Necrotizing Enterocolitis(36 weeks postmenstrual age)
- Post-intervention Retinopathy of Prematurity (ROP) ≥ stage 3 (according to the international classification)(36 weeks postmenstrual age)
- Weight or head circumference z-score change at 36 weeks(36 weeks postmenstrual age)
- Death between randomization and discharge from NICU(Randomization to 120 days' postnatal age, death, discharge, or transfer outside of the Study Center, whichever occurs first (an average of 112 days postnatal age))
- Moderate-Severe neurodevelopmental impairment (NDI), using current NRN Follow-Up Study definition(22 to 26 months)
- Moderate-Severe neurodevelopmental impairment (NDI) or death(22 to 26 months)
- Moderate or severe cerebral palsy(22 to 26 months)
- Severe vision impairment(22 to 26 months)
- Severe hearing impairment(22 to 26 months)
- Bayley-4 cognitive, language, motor scores(22 to 26 months)
- Gross Motor Function level ≥II(22 to 26 months)
- CBCL Internalizing, Externalizing, and Total Problems aggregate T scores of >64 (clinical range) and 60-63 (borderline range).(22 to 26 months)
- Death before 22-26-month follow-up(22 to 26 months)
- Height, weight, or head circumference growth failure(22 to 26 months)
研究者
研究点 (25)
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