Pulmonary Hypertension in Extremely Preterm Infants (PiEP)

Universitair Ziekenhuis Brussel

Status: Not yet enrolling

Conditions: Bronchopulmonary Dysplasia; Pulmonary Hypertension; Premature Birth

Treatments: Diagnostic Test: Echocardiography; Diagnostic Test: NT-proBNP

Study type: Interventional

Funder types: Other

Identifiers

NCT05136235

PiEP study

Details and patient eligibility

About

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.

Enrollment: 350 estimated patients

Sex: All

Ages: Under 2 weeks old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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350 participants in 1 patient group

Extremely preterm newborns

Other group

Description:

All extremely preterm newborns in Flanders will be included, it is a single arm study

Treatment:

Diagnostic Test: NT-proBNP

Diagnostic Test: Echocardiography