Pulmonary Hypertension in Extremely Preterm Infants

Not Applicable

Not yet recruiting

• Conditions: Pulmonary Hypertension; Bronchopulmonary Dysplasia; Premature Birth

• Registration Number: NCT05136235
• Lead Sponsor: Universitair Ziekenhuis Brussel

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-11-25
• Last Update Submitted: 2021-11-25
• Study First Posted: 2021-11-29
• Last Update Posted: 2021-11-29
• Study Start: 2022-01
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 350

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Presence of pulmonary hypertension	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 Outcome Measures

Name	Time	Method
Birth weight	at birth	Birth weight in grams
NEC	at 36 weeks	Presence of necrotizing enterocolitis
VAP	at 36 weeks	Presence of ventilator associated pneumonia
Presence of bronchopulmonary dysplasia	at 36 weeks PMA	Classification of BPD with an oxygen reduction test
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)
PDA	at 36 weeks	Presence of patent ductus arteriosus
Sepsis	up to discharge from the NICU, an average of 16 weeks	Presence of sepsis
ROP	at 36 weeks	Presence of retinopathy of prematurity