Pulmonary Hypertension in Extremely Preterm Infants

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.

Conditions

• Bronchopulmonary Dysplasia
• Pulmonary Hypertension
• Premature Birth

Interventions

DIAGNOSTIC_TEST

Echocardiography

There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period

DIAGNOSTIC_TEST

NT-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 & Collaborators

• AZ Sint-Jan AV

  collaborator OTHER

• Universitaire Ziekenhuizen KU Leuven

  collaborator OTHER

• GZA Ziekenhuizen Campus Sint-Augustinus

  collaborator OTHER

• Ziekenhuis Netwerk Antwerpen (ZNA)

  collaborator OTHER

• Ziekenhuis Oost-Limburg

  collaborator OTHER

• University Hospital, Ghent

  collaborator OTHER

• Universitair Ziekenhuis Brussel

  lead OTHER

Principal Investigators

• Barbara De Bisschop, MD · Universitair Ziekenhuis Brussel

• Filip Cools, PhD · Universitair Ziekenhuis Brussel

• Daniël De Wolf, PhD · Universitair Ziekenhuis Brussel

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Max Age

2 Weeks

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-01-31

Primary Completion

2025-12-31

Completion

2025-12-31