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Bronchopulmonary DysplasiaPiEPNCT05136235

Pulmonary Hypertension in Extremely Preterm Infants

A study testing Echocardiography and NT-proBNP in people with Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by Universitair Ziekenhuis Brussel.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages Up to 2 weeks
What is being tested?
Echocardiography and NT-proBNP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
350 participants
Where
No sites listed yet
Study dates
Jan 2022to Dec 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 2 weeks
  • All sexes
  • No healthy volunteers
  • Child

Who may be able to join

  • Gestational age <28 0/7 weeks
  • Birth weight <1000 grams

Who cannot join

  • Major congenital malformations
  • Structural airway or lung disease
  • Congenital heart disease
  • Lack of parental consent

Trial locations and contacts

No sites are listed yet.

Barbara De Bisschop, MD contact

0032 2 477 77 21

barbara.debisschop@gmail.com

About this study

Official title: Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study

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.

Being tested
Echocardiography, NT-proBNP
Medical subject headings
Bronchopulmonary Dysplasia, Hypertension, Pulmonary, Premature Birth

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EchocardiographyDiagnostic test

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

  • NT-proBNPDiagnostic test

    At 36 weeks postmenstrual age there will be screened for pulmonary hypertension by means of an NT-proBNP measurement in a blood sample

Study groups in NCT05136235
Study groupRoleWhat they receive
Extremely preterm newbornsOtherAll extremely preterm newborns in Flanders will be included, it is a single arm study
Receives: Diagnostic Test: Echocardiography; Diagnostic Test: NT-proBNP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Presence of pulmonary hypertension

    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

    Measured: 3-10 days of life (time depending on the timing of the first echocardiography)

  2. Presence of pulmonary hypertension

    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

    Measured: at 28 days of life

  3. Presence of pulmonary hypertension

    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

    Measured: at 36 weeks PMA

  4. Presence of pulmonary hypertension

    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

    Measured: at 6 months of age

  5. Presence of pulmonary hypertension

    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

    Measured: at 12 months of age

Secondary outcomes (12)

  1. Presence of bronchopulmonary dysplasia

    Assessment of supplemental oxygen

    Measured: at 28 days of life

  2. Presence of bronchopulmonary dysplasia

    Classification of BPD with an oxygen reduction test

    Measured: at 36 weeks PMA

  3. Birth weight

    Birth weight in grams

    Measured: at birth

  4. Gestational age

    Gestational age in weeks

    Measured: at birth

  5. Small for gestational age

    Birth weight <P3

    Measured: at birth

  6. Oligohydramnios

    Presence of oligohydramnios during pregnancy

    Measured: at birth

  7. Maternal hypertensive disorders

    Presence of maternal hypertensive disorders during pregnancy (pre-eclampsia, hypertension, HELLP)

    Measured: at birth

  8. ROP

    Presence of retinopathy of prematurity

    Measured: at 36 weeks

  9. NEC

    Presence of necrotizing enterocolitis

    Measured: at 36 weeks

  10. PDA

    Presence of patent ductus arteriosus

    Measured: at 36 weeks

  11. Sepsis

    Presence of sepsis

    Measured: up to discharge from the NICU, an average of 16 weeks

  12. VAP

    Presence of ventilator associated pneumonia

    Measured: at 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Nov 2021
  2. Study startJan 2022 (estimated)
  3. Primary completionDec 2025 (estimated)
  4. Study completionDec 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
350 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05136235
Sponsor's protocol ID
PiEP study
Acronym
PiEP
Status last verified
Oct 2021
First submitted
6 Oct 2021
Last updated
29 Nov 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Arjaans S, Zwart EAH, Ploegstra MJ, Bos AF, Kooi EMW, Hillege HL, Berger RMF. Identification of gaps in the current knowledge on pulmonary hypertension in extremely preterm infants: A systematic review and meta-analysis. Paediatr Perinat Epidemiol. 2018 May;32(3):258-267. doi: 10.1111/ppe.12444. Epub 2018 Jan 17.

    PubMed 29341209

  • Abman SH, Hansmann G, Archer SL, Ivy DD, Adatia I, Chung WK, Hanna BD, Rosenzweig EB, Raj JU, Cornfield D, Stenmark KR, Steinhorn R, Thebaud B, Fineman JR, Kuehne T, Feinstein JA, Friedberg MK, Earing M, Barst RJ, Keller RL, Kinsella JP, Mullen M, Deterding R, Kulik T, Mallory G, Humpl T, Wessel DL; American Heart Association Council on Cardiopulmonary, Critical Care, Perioperative and Resuscitation; Council on Clinical Cardiology; Council on Cardiovascular Disease in the Young; Council on Cardiovascular Radiology and Intervention; Council on Cardiovascular Surgery and Anesthesia; and the American Thoracic Society. Pediatric Pulmonary Hypertension: Guidelines From the American Heart Association and American Thoracic Society. Circulation. 2015 Nov 24;132(21):2037-99. doi: 10.1161/CIR.0000000000000329. Epub 2015 Nov 3.

    PubMed 26534956

  • Hilgendorff A, Apitz C, Bonnet D, Hansmann G. Pulmonary hypertension associated with acute or chronic lung diseases in the preterm and term neonate and infant. The European Paediatric Pulmonary Vascular Disease Network, endorsed by ISHLT and DGPK. Heart. 2016 May;102 Suppl 2:ii49-56. doi: 10.1136/heartjnl-2015-308591.

    PubMed 27053698

  • Krishnan U, Feinstein JA, Adatia I, Austin ED, Mullen MP, Hopper RK, Hanna B, Romer L, Keller RL, Fineman J, Steinhorn R, Kinsella JP, Ivy DD, Rosenzweig EB, Raj U, Humpl T, Abman SH; Pediatric Pulmonary Hypertension Network (PPHNet). Evaluation and Management of Pulmonary Hypertension in Children with Bronchopulmonary Dysplasia. J Pediatr. 2017 Sep;188:24-34.e1. doi: 10.1016/j.jpeds.2017.05.029. Epub 2017 Jun 20. No abstract available.

    PubMed 28645441

  • Levy PT, Jain A, Nawaytou H, Teitel D, Keller R, Fineman J, Steinhorn R, Abman SH, McNamara PJ; Pediatric Pulmonary Hypertension Network (PPHNet). Risk Assessment and Monitoring of Chronic Pulmonary Hypertension in Premature Infants. J Pediatr. 2020 Feb;217:199-209.e4. doi: 10.1016/j.jpeds.2019.10.034. Epub 2019 Nov 14. No abstract available.

    PubMed 31735418

Questions about this trial

What is this clinical trial studying?

A study testing Echocardiography and NT-proBNP in people with Bronchopulmonary Dysplasia and Pulmonary Hypertension, run by Universitair Ziekenhuis Brussel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Barbara De Bisschop, MD (0032 2 477 77 21, barbara.debisschop@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Presence of pulmonary hypertension (time frame: 3-10 days of life (time depending on the timing of the first echocardiography)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05136235, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2021; AzTrials last refreshed its copy on 31 Oct 2026.

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