Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-24 @ 10:23 PM
Study NCT ID:
NCT05136235
Status:
NOT_YET_RECRUITING
Last Update Posted:
2021-11-29
First Post:
2021-10-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pulmonary Hypertension in Extremely Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D055397', 'term': 'Ventilator-Induced Lung Injury'}, {'id': 'D055370', 'term': 'Lung Injury'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D007235', 'term': 'Infant, Premature, Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004452', 'term': 'Echocardiography'}], 'ancestors': [{'id': 'D057791', 'term': 'Cardiac Imaging Techniques'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014463', 'term': 'Ultrasonography'}, {'id': 'D006334', 'term': 'Heart Function Tests'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 350}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-25', 'studyFirstSubmitDate': '2021-10-06', 'studyFirstSubmitQcDate': '2021-11-25', 'lastUpdatePostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of pulmonary hypertension', 'timeFrame': '3-10 days of life (time depending on the timing of the first echocardiography)', 'description': 'Pulmonary hypertension will be defined as one or more of the following echocardiographic findings:\n\n* Presence of a cardiac shunt with bidirectional or right-to-left flow\n* Estimated right ventricular systolic pressure (RVSP) \\>40 mmHg\n* RVSP/systemic systolic blood pressure (SBP) ratio \\>0.5\n* Presence of ventricular septal wall flattening'}, {'measure': 'Presence of pulmonary hypertension', 'timeFrame': 'at 28 days of life', 'description': 'Pulmonary hypertension will be defined as one or more of the following echocardiographic findings:\n\n* Presence of a cardiac shunt with bidirectional or right-to-left flow\n* Estimated right ventricular systolic pressure (RVSP) \\>40 mmHg\n* RVSP/systemic systolic blood pressure (SBP) ratio \\>0.5\n* Presence of ventricular septal wall flattening'}, {'measure': 'Presence of pulmonary hypertension', 'timeFrame': 'at 36 weeks PMA', 'description': 'Pulmonary hypertension will be defined as one or more of the following echocardiographic findings:\n\n* Presence of a cardiac shunt with bidirectional or right-to-left flow\n* Estimated right ventricular systolic pressure (RVSP) \\>40 mmHg\n* RVSP/systemic systolic blood pressure (SBP) ratio \\>0.5\n* Presence of ventricular septal wall flattening'}, {'measure': 'Presence of pulmonary hypertension', 'timeFrame': 'at 6 months of age', 'description': 'Pulmonary hypertension will be defined as one or more of the following echocardiographic findings:\n\n* Presence of a cardiac shunt with bidirectional or right-to-left flow\n* Estimated right ventricular systolic pressure (RVSP) \\>40 mmHg\n* RVSP/systemic systolic blood pressure (SBP) ratio \\>0.5\n* Presence of ventricular septal wall flattening'}, {'measure': 'Presence of pulmonary hypertension', 'timeFrame': 'at 12 months of age', 'description': 'Pulmonary hypertension will be defined as one or more of the following echocardiographic findings:\n\n* Presence of a cardiac shunt with bidirectional or right-to-left flow\n* Estimated right ventricular systolic pressure (RVSP) \\>40 mmHg\n* RVSP/systemic systolic blood pressure (SBP) ratio \\>0.5\n* Presence of ventricular septal wall flattening'}], 'secondaryOutcomes': [{'measure': 'Presence of bronchopulmonary dysplasia', 'timeFrame': 'at 28 days of life', 'description': 'Assessment of supplemental oxygen'}, {'measure': 'Presence of bronchopulmonary dysplasia', 'timeFrame': 'at 36 weeks PMA', 'description': 'Classification of BPD with an oxygen reduction test'}, {'measure': 'Birth weight', 'timeFrame': 'at birth', 'description': 'Birth weight in grams'}, {'measure': 'Gestational age', 'timeFrame': 'at birth', 'description': 'Gestational age in weeks'}, {'measure': 'Small for gestational age', 'timeFrame': 'at birth', 'description': 'Birth weight \\<P3'}, {'measure': 'Oligohydramnios', 'timeFrame': 'at birth', 'description': 'Presence of oligohydramnios during pregnancy'}, {'measure': 'Maternal hypertensive disorders', 'timeFrame': 'at birth', 'description': 'Presence of maternal hypertensive disorders during pregnancy (pre-eclampsia, hypertension, HELLP)'}, {'measure': 'ROP', 'timeFrame': 'at 36 weeks', 'description': 'Presence of retinopathy of prematurity'}, {'measure': 'NEC', 'timeFrame': 'at 36 weeks', 'description': 'Presence of necrotizing enterocolitis'}, {'measure': 'PDA', 'timeFrame': 'at 36 weeks', 'description': 'Presence of patent ductus arteriosus'}, {'measure': 'Sepsis', 'timeFrame': 'up to discharge from the NICU, an average of 16 weeks', 'description': 'Presence of sepsis'}, {'measure': 'VAP', 'timeFrame': 'at 36 weeks', 'description': 'Presence of ventilator associated pneumonia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bronchopulmonary Dysplasia', 'Pulmonary Hypertension', 'Premature Birth']}, 'referencesModule': {'references': [{'pmid': '29341209', 'type': 'BACKGROUND', '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.'}, {'pmid': '26534956', 'type': 'BACKGROUND', '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.'}, {'pmid': '27053698', 'type': 'BACKGROUND', '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.'}, {'pmid': '28645441', 'type': 'BACKGROUND', '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.'}, {'pmid': '31735418', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nThus, 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '2 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria: Preterm infants with\n\n* Gestational age \\<28 0/7 weeks\n* Birth weight \\<1000 grams\n\nExclusion Criteria:\n\n* Major congenital malformations\n* Structural airway or lung disease\n* Congenital heart disease\n* Lack of parental consent'}, 'identificationModule': {'nctId': 'NCT05136235', 'acronym': 'PiEP', 'briefTitle': 'Pulmonary Hypertension in Extremely Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Pulmonary Hypertension in Extremely Preterm Infants - A Prospective Cohort Study', 'orgStudyIdInfo': {'id': 'PiEP study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Extremely preterm newborns', 'description': 'All extremely preterm newborns in Flanders will be included, it is a single arm study', 'interventionNames': ['Diagnostic Test: Echocardiography', 'Diagnostic Test: NT-proBNP']}], 'interventions': [{'name': 'Echocardiography', 'type': 'DIAGNOSTIC_TEST', 'description': 'There will be screened for pulmonary hypertension by means of serial echocardiographies during the study period', 'armGroupLabels': ['Extremely preterm newborns']}, {'name': 'NT-proBNP', 'type': 'DIAGNOSTIC_TEST', 'description': 'At 36 weeks postmenstrual age there will be screened for pulmonary hypertension by means of an NT-proBNP measurement in a blood sample', 'armGroupLabels': ['Extremely preterm newborns']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Barbara De Bisschop, MD', 'role': 'CONTACT', 'email': 'barbara.debisschop@gmail.com', 'phone': '0032 2 477 77 21'}], 'overallOfficials': [{'name': 'Barbara De Bisschop, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Filip Cools, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}, {'name': 'Daniël De Wolf, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universitair Ziekenhuis Brussel'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'collaborators': [{'name': 'AZ Sint-Jan AV', 'class': 'OTHER'}, {'name': 'Universitaire Ziekenhuizen KU Leuven', 'class': 'OTHER'}, {'name': 'GZA Ziekenhuizen Campus Sint-Augustinus', 'class': 'OTHER'}, {'name': 'Ziekenhuis Netwerk Antwerpen (ZNA)', 'class': 'OTHER'}, {'name': 'Ziekenhuis Oost-Limburg', 'class': 'OTHER'}, {'name': 'University Hospital, Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}