Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 入组人数
- 350
- 主要终点
- Presence of pulmonary hypertension
研究概览
简要总结
Extremely preterm infants are at risk for developing bronchopulmonary dysplasia (BPD) and associated chronic pulmonary hypertension (PH), a consequence of altered pulmonary vasculature. This condition occurs in about 25% of babies with BPD, and the association grows with increasing BPD severity. Other risk factors have been described as well. Morbidity and mortality associated with prematurity and/or BPD increase significantly in the presence of PH.
Thus, international guidelines encourage the use of standardized screening protocols for this condition. However, several questions regarding these recommendations are left unanswered, such as a clear definition for PH in this population.
The research aim is to prospectively evaluate prevalence, risk factors and clinical course of PH in these children. The investigators aim to identify at-risk infants early on and ultimately improve survival making use of an early targeted intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- — 至 2 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants with
- •Gestational age <28 0/7 weeks
- •Birth weight <1000 grams
排除标准
- •Major congenital malformations
- •Structural airway or lung disease
- •Congenital heart disease
- •Lack of parental consent
研究组 & 干预措施
Extremely preterm newborns
All extremely preterm newborns in Flanders will be included, it is a single arm study
干预措施: Echocardiography (Diagnostic Test)
Extremely preterm newborns
All extremely preterm newborns in Flanders will be included, it is a single arm study
干预措施: NT-proBNP (Diagnostic Test)
结局指标
主要结局
Presence of pulmonary hypertension
时间窗: at 12 months of age
Pulmonary hypertension will be defined as one or more of the following echocardiographic findings: * Presence of a cardiac shunt with bidirectional or right-to-left flow * Estimated right ventricular systolic pressure (RVSP) \>40 mmHg * RVSP/systemic systolic blood pressure (SBP) ratio \>0.5 * Presence of ventricular septal wall flattening
Presence of pulmonary hypertension
时间窗: 3-10 days of life (time depending on the timing of the first echocardiography)
Pulmonary hypertension will be defined as one or more of the following echocardiographic findings: * Presence of a cardiac shunt with bidirectional or right-to-left flow * Estimated right ventricular systolic pressure (RVSP) \>40 mmHg * RVSP/systemic systolic blood pressure (SBP) ratio \>0.5 * Presence of ventricular septal wall flattening
Presence of pulmonary hypertension
时间窗: at 28 days of life
Pulmonary hypertension will be defined as one or more of the following echocardiographic findings: * Presence of a cardiac shunt with bidirectional or right-to-left flow * Estimated right ventricular systolic pressure (RVSP) \>40 mmHg * RVSP/systemic systolic blood pressure (SBP) ratio \>0.5 * Presence of ventricular septal wall flattening
Presence of pulmonary hypertension
时间窗: at 36 weeks PMA
Pulmonary hypertension will be defined as one or more of the following echocardiographic findings: * Presence of a cardiac shunt with bidirectional or right-to-left flow * Estimated right ventricular systolic pressure (RVSP) \>40 mmHg * RVSP/systemic systolic blood pressure (SBP) ratio \>0.5 * Presence of ventricular septal wall flattening
Presence of pulmonary hypertension
时间窗: at 6 months of age
Pulmonary hypertension will be defined as one or more of the following echocardiographic findings: * Presence of a cardiac shunt with bidirectional or right-to-left flow * Estimated right ventricular systolic pressure (RVSP) \>40 mmHg * RVSP/systemic systolic blood pressure (SBP) ratio \>0.5 * Presence of ventricular septal wall flattening
次要结局
- Birth weight(at birth)
- ROP(at 36 weeks)
- NEC(at 36 weeks)
- VAP(at 36 weeks)
- Presence of bronchopulmonary dysplasia(at 36 weeks PMA)
- Gestational age(at birth)
- Small for gestational age(at birth)
- Oligohydramnios(at birth)
- Maternal hypertensive disorders(at birth)
- PDA(at 36 weeks)
- Sepsis(up to discharge from the NICU, an average of 16 weeks)
- Presence of bronchopulmonary dysplasia(at 28 days of life)