Bronchopulmonary Dysplasia, Premature Birth, Pulmonary Hypertension
Conditions
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.
Interventions
DIAGNOSTIC_TESTEchocardiography
There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period
DIAGNOSTIC_TESTNT-proBNP
At 36 weeks postmenstrual age there will be screened for pulmonary hypertension by means of an NT-proBNP measurement in a blood sample
Sponsors
AZ Sint-Jan AV
Universitaire Ziekenhuizen KU Leuven
GZA Ziekenhuizen Campus Sint-Augustinus
Ziekenhuis Netwerk Antwerpen (ZNA)
Ziekenhuis Oost-Limburg
University Hospital, Ghent
Universitair Ziekenhuis Brussel
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Weeks
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Presence of pulmonary hypertension | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Birth weight | at birth | Birth weight in grams |
| Gestational age | at birth | Gestational age in weeks |
| Small for gestational age | at birth | Birth weight \<P3 |
| Oligohydramnios | at birth | Presence of oligohydramnios during pregnancy |
| Maternal hypertensive disorders | at birth | Presence of maternal hypertensive disorders during pregnancy (pre-eclampsia, hypertension, HELLP) |
| Presence of bronchopulmonary dysplasia | at 28 days of life | Assessment of supplemental oxygen |
| NEC | at 36 weeks | Presence of necrotizing enterocolitis |
| PDA | at 36 weeks | Presence of patent ductus arteriosus |
| Sepsis | up to discharge from the NICU, an average of 16 weeks | Presence of sepsis |
| VAP | at 36 weeks | Presence of ventilator associated pneumonia |
| ROP | at 36 weeks | Presence of retinopathy of prematurity |
Contacts
Primary ContactBarbara De Bisschop, MD
Outcome results
None listed