Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bronchopulmonary Dysplasia
- Sponsor
- Universitair Ziekenhuis Brussel
- Enrollment
- 350
- Primary Endpoint
- Presence of pulmonary hypertension
- Status
- Not yet recruiting
- Last Updated
- 4 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Preterm infants with
- •Gestational age \<28 0/7 weeks
- •Birth weight \<1000 grams
Exclusion Criteria
- •Major congenital malformations
- •Structural airway or lung disease
- •Congenital heart disease
- •Lack of parental consent
Outcomes
Primary Outcomes
Presence of pulmonary hypertension
Time Frame: 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
Secondary Outcomes
- PDA(at 36 weeks)
- Sepsis(up to discharge from the NICU, an average of 16 weeks)
- 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)