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Pulmonary Hypertension in Extremely Preterm Infants (PiEP)

Primary Purpose

Bronchopulmonary Dysplasia, Pulmonary Hypertension, Premature Birth

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Echocardiography
NT-proBNP
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Bronchopulmonary Dysplasia

Eligibility Criteria

undefined - 2 Weeks (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Extremely preterm newborns

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    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
    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
    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
    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
    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

    Secondary Outcome Measures

    Presence of bronchopulmonary dysplasia
    Assessment of supplemental oxygen
    Presence of bronchopulmonary dysplasia
    Classification of BPD with an oxygen reduction test
    Birth weight
    Birth weight in grams
    Gestational age
    Gestational age in weeks
    Small for gestational age
    Birth weight <P3
    Oligohydramnios
    Presence of oligohydramnios during pregnancy
    Maternal hypertensive disorders
    Presence of maternal hypertensive disorders during pregnancy (pre-eclampsia, hypertension, HELLP)
    ROP
    Presence of retinopathy of prematurity
    NEC
    Presence of necrotizing enterocolitis
    PDA
    Presence of patent ductus arteriosus
    Sepsis
    Presence of sepsis
    VAP
    Presence of ventilator associated pneumonia

    Full Information

    First Posted
    October 6, 2021
    Last Updated
    November 25, 2021
    Sponsor
    Universitair Ziekenhuis Brussel
    Collaborators
    AZ Sint-Jan AV, Universitaire Ziekenhuizen KU Leuven, GZA Ziekenhuizen Campus Sint-Augustinus, Ziekenhuis Netwerk Antwerpen (ZNA), Ziekenhuis Oost-Limburg, University Hospital, Ghent
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05136235
    Brief Title
    Pulmonary Hypertension in Extremely Preterm Infants
    Acronym
    PiEP
    Official Title
    Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2022 (Anticipated)
    Primary Completion Date
    December 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitair Ziekenhuis Brussel
    Collaborators
    AZ Sint-Jan AV, Universitaire Ziekenhuizen KU Leuven, GZA Ziekenhuizen Campus Sint-Augustinus, Ziekenhuis Netwerk Antwerpen (ZNA), Ziekenhuis Oost-Limburg, University Hospital, Ghent

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bronchopulmonary Dysplasia, Pulmonary Hypertension, Premature Birth

    7. Study Design

    Primary Purpose
    Screening
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    350 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Extremely preterm newborns
    Arm Type
    Other
    Arm Description
    All extremely preterm newborns in Flanders will be included, it is a single arm study
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Echocardiography
    Intervention Description
    There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    NT-proBNP
    Intervention Description
    At 36 weeks postmenstrual age there will be screened for pulmonary hypertension by means of an NT-proBNP measurement in a blood sample
    Primary Outcome Measure Information:
    Title
    Presence of pulmonary hypertension
    Description
    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
    Time Frame
    3-10 days of life (time depending on the timing of the first echocardiography)
    Title
    Presence of pulmonary hypertension
    Description
    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
    Time Frame
    at 28 days of life
    Title
    Presence of pulmonary hypertension
    Description
    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
    Time Frame
    at 36 weeks PMA
    Title
    Presence of pulmonary hypertension
    Description
    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
    Time Frame
    at 6 months of age
    Title
    Presence of pulmonary hypertension
    Description
    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
    Time Frame
    at 12 months of age
    Secondary Outcome Measure Information:
    Title
    Presence of bronchopulmonary dysplasia
    Description
    Assessment of supplemental oxygen
    Time Frame
    at 28 days of life
    Title
    Presence of bronchopulmonary dysplasia
    Description
    Classification of BPD with an oxygen reduction test
    Time Frame
    at 36 weeks PMA
    Title
    Birth weight
    Description
    Birth weight in grams
    Time Frame
    at birth
    Title
    Gestational age
    Description
    Gestational age in weeks
    Time Frame
    at birth
    Title
    Small for gestational age
    Description
    Birth weight <P3
    Time Frame
    at birth
    Title
    Oligohydramnios
    Description
    Presence of oligohydramnios during pregnancy
    Time Frame
    at birth
    Title
    Maternal hypertensive disorders
    Description
    Presence of maternal hypertensive disorders during pregnancy (pre-eclampsia, hypertension, HELLP)
    Time Frame
    at birth
    Title
    ROP
    Description
    Presence of retinopathy of prematurity
    Time Frame
    at 36 weeks
    Title
    NEC
    Description
    Presence of necrotizing enterocolitis
    Time Frame
    at 36 weeks
    Title
    PDA
    Description
    Presence of patent ductus arteriosus
    Time Frame
    at 36 weeks
    Title
    Sepsis
    Description
    Presence of sepsis
    Time Frame
    up to discharge from the NICU, an average of 16 weeks
    Title
    VAP
    Description
    Presence of ventilator associated pneumonia
    Time Frame
    at 36 weeks

    10. Eligibility

    Sex
    All
    Maximum Age & Unit of Time
    2 Weeks
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Barbara De Bisschop, MD
    Phone
    0032 2 477 77 21
    Email
    barbara.debisschop@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Barbara De Bisschop, MD
    Organizational Affiliation
    Universitair Ziekenhuis Brussel
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Filip Cools, PhD
    Organizational Affiliation
    Universitair Ziekenhuis Brussel
    Official's Role
    Study Chair
    First Name & Middle Initial & Last Name & Degree
    Daniël De Wolf, PhD
    Organizational Affiliation
    Universitair Ziekenhuis Brussel
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    29341209
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    26534956
    Citation
    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. Erratum In: Circulation. 2016 Jan 26;133(4):e368.
    Results Reference
    background
    PubMed Identifier
    27053698
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    28645441
    Citation
    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.
    Results Reference
    background
    PubMed Identifier
    31735418
    Citation
    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.
    Results Reference
    background

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    Pulmonary Hypertension in Extremely Preterm Infants

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