Novel Radiological Markers for PDA-Targeted Management in Preterm Infants: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 88
- 主要终点
- PDA neonates survival without major morbidity.
研究概览
简要总结
The aim of this Randomized controlled trial is to determine whether Echo with Organ Doppler-guided management strategy for hemodynamically significant patent ductus arteriosus (hsPDA) improves the short-term outcomes compared with standard care in preterm neonates.
the research question is Does the usage of new radiological markers minimize the hsPDA group and decrease the pharmacological management in order to decrease the side effects of the treatment ? Researchers will compare the Echo with Organ Doppler management group to the standard care group.
详细描述
- All neonates enrolled in the study will be subjected for:
Demographic data
• Gestational age at birth, birth weight (grams), sex, mode of delivery, Ballard score, Apgar score and anthropometric measurement.
Maternal data • Including antenatal corticosteroid exposure, history of chorioamnionitis and premature rupture of membranes.
Medical History
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 0 Hours 至 96 Hours（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gestational age <34 weeks and/or birth weight <1800 g.
- •Admitted to the NICU at Assiut University Children Hospital within the first 24 hours of life.
- •First echocardiographic assessment performed between 24 and 72 hours of life.
排除标准
- •Major congenital heart disease other than PDA (e.g., coarctation, critical left heart lesions).
- •Life-limiting congenital anomalies or chromosomal disorders.
- •Severe septic shock or multiorgan failure at time of first assessment.
- •Death or transfer before completion of initial Echo and Doppler (<24 hours of life).
研究组 & 干预措施
Group 1 (Intervention): Echo and Organ Doppler-guided management
GROUP 1: INTERVENTION (Echo and Doppler-Guided) Initial Assessment (24-72 hours)
All infants in the intervention group undergo:
1. Comprehensive Echocardiography
Timing of Assessments
- T0: 24-72 hours of life (baseline).
- T1: Prior to PDA treatment (if hsPDA diagnosed in Intervention group).
- T2: 24-48 hours after treatment.
- All scans are performed by the principal investigator (neonatologist) using a standardized protocol. Images and Doppler traces are stored for quality control.
ECHO parameters:
Include a statement on hemodynamic significance based on 5 parameters:
- Diameter
- Flow direction
- Systolic and diastolic flow velocities
- Indices of pulmonary over circulation
- Left ventricular output - Plus, one parameter of left sided volume loading or left heart pressure loading, systemic shunt effect, doppler flow patterns in the systemic circulation.
2. Organ Doppler (Superior mesenteric artery (SMA) and Middle cerebral artery (MCA)
干预措施: Organ doppler (Diagnostic Test)
Group 1 (Intervention): Echo and Organ Doppler-guided management
GROUP 1: INTERVENTION (Echo and Doppler-Guided) Initial Assessment (24-72 hours)
All infants in the intervention group undergo:
1. Comprehensive Echocardiography
Timing of Assessments
- T0: 24-72 hours of life (baseline).
- T1: Prior to PDA treatment (if hsPDA diagnosed in Intervention group).
- T2: 24-48 hours after treatment.
- All scans are performed by the principal investigator (neonatologist) using a standardized protocol. Images and Doppler traces are stored for quality control.
ECHO parameters:
Include a statement on hemodynamic significance based on 5 parameters:
- Diameter
- Flow direction
- Systolic and diastolic flow velocities
- Indices of pulmonary over circulation
- Left ventricular output - Plus, one parameter of left sided volume loading or left heart pressure loading, systemic shunt effect, doppler flow patterns in the systemic circulation.
2. Organ Doppler (Superior mesenteric artery (SMA) and Middle cerebral artery (MCA)
干预措施: Echocardiography (Diagnostic Test)
GROUP 2: CONTROL (Standard Clinical + Echo-Guided)
Step 1: Initial assessment (24-72 hours) and classification based on clinical criteria and Echo (without doppler):
-
Clinical criteria:
-
Oxygen requirement >30% OR
-
Respiratory support (CPAP/ventilator) OR
-
Wide pulse pressure (>25 mmHg) OR
-
Bounding pulses.
-
Echo criteria:
Include a statement on hemodynamic significance based on 5 parameters: (Winners et al. (2023).
- Diameter
- Flow direction
- Systolic and diastolic flow velocities
- Indices of pulmonary over circulation
- Left ventricular output.
Step 2: Treatment Decision Patients with both clinical signs and echocardiographic evidence of a significant PDA were classified as hsPDA and received pharmacological treatment. In contrast, patients with no clinical signs and/or non-significant echocardiographic findings were classified as non-significant PDA and received supportive care only. This approach was based on traditional clinical and echocardiographic criteria without organ Doppler assessment.
干预措施: Organ doppler (Diagnostic Test)
结局指标
主要结局
PDA neonates survival without major morbidity.
时间窗: one year
Composite of survival without major morbidity until 36 weeks PMA or discharge: * No BPD (oxygen/respiratory support at 36 weeks PMA). * No NEC ≥ Bell stage II. * No IVH ≥ grade II (Papile classification). * No death.
次要结局
未报告次要终点
研究者
Yosra Alaa Abd El-baset Ali Khallaf
Assistant lecturer
Assiut University