Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
350 participants
INTERVENTIONAL
2022-01-31
2025-12-31
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Extremely preterm newborns
All extremely preterm newborns in Flanders will be included, it is a single arm study
Echocardiography
There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period
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
Interventions
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Echocardiography
There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period
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
Eligibility Criteria
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Inclusion Criteria
* Birth weight \<1000 grams
Exclusion Criteria
* Structural airway or lung disease
* Congenital heart disease
* Lack of parental consent
2 Weeks
ALL
No
Sponsors
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AZ Sint-Jan AV
OTHER
Universitaire Ziekenhuizen KU Leuven
OTHER
GZA Ziekenhuizen Campus Sint-Augustinus
OTHER
Ziekenhuis Netwerk Antwerpen (ZNA)
OTHER
Ziekenhuis Oost-Limburg
OTHER
University Hospital, Ghent
OTHER
Universitair Ziekenhuis Brussel
OTHER
Responsible Party
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Principal Investigators
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Barbara De Bisschop, MD
Role: PRINCIPAL_INVESTIGATOR
Universitair Ziekenhuis Brussel
Filip Cools, PhD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Daniël De Wolf, PhD
Role: STUDY_CHAIR
Universitair Ziekenhuis Brussel
Central Contacts
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References
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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.
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.
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.
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.
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.
Other Identifiers
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PiEP study
Identifier Type: -
Identifier Source: org_study_id