Ignite Creation Date:
2025-12-25 @ 3:53 AM
Ignite Modification Date:
2025-12-26 @ 2:42 AM
Study NCT ID:
NCT05987202
Status:
RECRUITING
Last Update Posted:
2024-01-18
First Post:
2023-08-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Betamethasone and Closure of Ductus Arteriosus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004374', 'term': 'Ductus Arteriosus, Patent'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D001997', 'term': 'Bronchopulmonary Dysplasia'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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'}, {'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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 51}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-17', 'studyFirstSubmitDate': '2023-08-02', 'studyFirstSubmitQcDate': '2023-08-09', 'lastUpdatePostDateStruct': {'date': '2024-01-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of children with favorable evolution of the CAP', 'timeFrame': 'through study completion, an average of 6 months', 'description': 'Number of children with favorable evolution of the CAP Percentage of children who present a favorable evolution of the CAP defined as a closure of the CAP or a CAP which becomes hemodynamically insignificant, under the effect of treatment with BTM'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prematurity', 'Ductus arteriosus', 'Steroids', 'Betamethasone', 'Bronchopulmonary dysplasia'], 'conditions': ['Persistent Ductus Arteriosus']}, 'referencesModule': {'references': [{'pmid': '39604779', 'type': 'DERIVED', 'citation': 'Remy A, Vincent M, Pastor-Diez B, Picaud JC. Late postnatal steroid treatment using oral betamethasone can help to close ductus arteriosus in extremely preterm infants who cannot be weaned from ventilation. Eur J Pediatr. 2024 Nov 28;184(1):50. doi: 10.1007/s00431-024-05840-9.'}]}, 'descriptionModule': {'briefSummary': 'The ductus arteriosus (DA) normally closes after birth as a result of exposure to oxygen. Its persistence of DA (PDA) occurs in 20 to 50% of very preterm infants and is associated with significant morbidity and mortality: prolongation of respiratory assistance, pulmonary haemorrhage, -necrotizing enterocolitis (NECU), intraventricular haemorrhage and death.\n\nPDA management is one of the most discussed aspects in neonatology. The treatment is either conservative (controlled fluid intake, monitoring of cerebral flows, diuretics), or pharmacological (ibuprofen or paracetamol per os), or surgical (thoracotomy + ligature or catheterization + plug). The success rate of pharmacological treatment of CAP is 30% in the most immature children. When medical treatment fails, surgical or endovascular treatment is considered. However, these are associated with complications such as recurrent nerve lesion, thoracotomy, failure to close DA, migration of the plug. Therefore individualized assessment balances the expected benefits of CAP treatment against the risks associated with the treatments for each patient.\n\nThe main complication of CAP is the impossibility of weaning the patient from ventilatory assistance. On the one hand because of PDA, but also very often because of the concomitant development of bronchopulmonary dysplasia (BPD) due to pulmonary lesions secondary to assisted ventilation and especially to inflammation. At 3 weeks of life, if attempts at ventilatory weaning have failed, postnatal corticosteroid therapy is considered in the 4th week of life in accordance with current recommendations.\n\nThe most commonly used postnatal corticosteroids are dexamethasone (DXM), hydrocortisone hemisuccinate (HSHC) and betamethasone (BTM). DXM (intravenous) is effective and is the most widely used product worldwide, but its use is associated with impaired postnatal growth and suboptimal neurodevelopment. HSHC (intravenous) is an alternative to DXM and has shown some effectiveness, without the adverse effects of DXM. The BTM is also an alternative, but has been used less than the other products because it is not widely available in some countries. Its advantage is that it can be given orally, but there is little published data on the effect of BTM. In this context, it has been used in some neonatal units and have shown some effectiveness.\n\nIn the Neonatology department of the Croix Rousse hospital, oral BTM has been used since 2005 and has been evaluated favorably, since it allows the child to be weaned from ventilatory assistance. When using BTM, we observed not only a positive respiratory effect, but also DA closure, reducing the need for ligation of the ductus arteriosus by surgery or catheterization'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '1 Year', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Infants born between january 2018 and December 2022, at a gestational age below 37 weeks, hospitalized in the Neonatal unit of Croix-Rousse hospital, presenting an hemodynamically significant DA and treated by BTM for bronchopulmonary dysplasia', 'healthyVolunteers': False, 'eligibilityCriteria': '* Inclusion Criteria :\n\n * born between January 2018 and December 2022\n * at a gestational age below 37 weeks,\n * hospitalized in the Neonatal unit of Croix-Rousse hospital,\n * presenting a hemodynamically significant DA\n * treated by BTM for bronchopulmonary dysplasia\n* Exclusion Criteria :\n\n * Children having closed their ductus arteriosus before administration of the betamethasone course\n * Children who died before or during treatment.'}, 'identificationModule': {'nctId': 'NCT05987202', 'acronym': 'CELESTE', 'briefTitle': 'Betamethasone and Closure of Ductus Arteriosus', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Impact of Postnatal Betamethasone Treatment on Closure of Ductus Arteriosus in Preterm Infants', 'orgStudyIdInfo': {'id': '69HCL23_0779'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Preterm infants born between January 1st, 2018 and December 31st, 2022', 'description': 'All infants born alive before 37 weeks between January 1st, 2018 and December 31st, 2022 with PDA', 'interventionNames': ['Other: DA closure in a population of premature infants']}], 'interventions': [{'name': 'DA closure in a population of premature infants', 'type': 'OTHER', 'description': 'Evaluate the incidence of DA closure in a population of premature infants treated with BTM per os for bronchopulmonary dysplasia', 'armGroupLabels': ['Preterm infants born between January 1st, 2018 and December 31st, 2022']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69317', 'city': 'Lyon', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Charles PICAUD, Pr', 'role': 'CONTACT', 'email': 'jean-charles.picaud@chu-lyon.fr', 'phone': '04 72 00 41 24', 'phoneExt': '+33'}], 'facility': 'Service de Réanimation néonatale - Hôpital de la Croix Rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}