NCT05136235

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2022

Longer than P75 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 6, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 29, 2021

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 29, 2021

Status Verified

October 1, 2021

Enrollment Period

3.9 years

First QC Date

October 6, 2021

Last Update Submit

November 25, 2021

Conditions

Bronchopulmonary DysplasiaPulmonary HypertensionPremature Birth

Outcome Measures

Primary Outcomes (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

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

  • 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

    at 28 days of life

  • 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

    at 36 weeks PMA

  • 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

    at 6 months of age

  • 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

    at 12 months of age

Secondary Outcomes (12)

  • Presence of bronchopulmonary dysplasia

    at 28 days of life

  • Presence of bronchopulmonary dysplasia

    at 36 weeks PMA

  • Birth weight

    at birth

  • Gestational age

    at birth

  • Small for gestational age

    at birth

  • +7 more secondary outcomes

Study Arms (1)

Extremely preterm newborns

OTHER

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

Diagnostic Test: EchocardiographyDiagnostic Test: NT-proBNP

Interventions

EchocardiographyDIAGNOSTIC_TEST

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

Extremely preterm newborns
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

Extremely preterm newborns

Eligibility Criteria

AgeUp to 2 Weeks
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 29341209BACKGROUND

  • 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.

    PMID: 26534956BACKGROUND

  • 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.

    PMID: 27053698BACKGROUND

  • 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.

    PMID: 28645441BACKGROUND

  • 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.

    PMID: 31735418BACKGROUND

MeSH Terms

Conditions

Bronchopulmonary DysplasiaHypertension, PulmonaryPremature Birth

Interventions

Echocardiography

Condition Hierarchy (Ancestors)

Ventilator-Induced Lung InjuryLung InjuryLung DiseasesRespiratory Tract DiseasesInfant, Premature, DiseasesInfant, Newborn, DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesHypertensionVascular DiseasesCardiovascular DiseasesObstetric Labor, PrematureObstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging TechniquesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisUltrasonographyHeart Function TestsDiagnostic Techniques, Cardiovascular

Study Officials

  • Barbara De Bisschop, MD

    Universitair Ziekenhuis Brussel

    PRINCIPAL INVESTIGATOR

  • Filip Cools, PhD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

  • Daniël De Wolf, PhD

    Universitair Ziekenhuis Brussel

    STUDY CHAIR

Central Study Contacts

Barbara De Bisschop, MD

CONTACT

0032 2 477 77 21barbara.debisschop@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 6, 2021

First Posted

November 29, 2021

Study Start

January 1, 2022

Primary Completion

December 1, 2025

Study Completion

December 1, 2025

Last Updated

November 29, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share