Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT01536158
Status:
COMPLETED
Last Update Posted:
2012-12-27
First Post:
2012-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial
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'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000082', 'term': 'Acetaminophen'}, {'id': 'D007052', 'term': 'Ibuprofen'}], 'ancestors': [{'id': 'D000083', 'term': 'Acetanilides'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010666', 'term': 'Phenylpropionates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-12', 'completionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-12-24', 'studyFirstSubmitDate': '2012-02-15', 'studyFirstSubmitQcDate': '2012-02-17', 'lastUpdatePostDateStruct': {'date': '2012-12-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Efficacy and Safety of Oral Paracetamol Versus Oral Ibuprofen', 'timeFrame': 'Until discharge', 'description': 'To compare the closure rate of patent ductus arteriosus after oral paracetamol or oral ibuprofen treatment'}], 'secondaryOutcomes': [{'measure': 'Long term effects of oral paracetamol versus oral ibuprofen treatment in preterm infants', 'timeFrame': 'corrected 36 weeks or until discharge', 'description': 'Long term effects such as ROP, BPD,IVH, duration of respiratory support and hospitalization are going to be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Patent Ductus Arteriosus', 'Paracetamol', 'Ibuprofen', 'Preterm infant'], 'conditions': ['Patent Ductus Arteriosus']}, 'referencesModule': {'references': [{'pmid': '36519620', 'type': 'DERIVED', 'citation': 'Jasani B, Mitra S, Shah PS. Paracetamol (acetaminophen) for patent ductus arteriosus in preterm or low birth weight infants. Cochrane Database Syst Rev. 2022 Dec 15;12(12):CD010061. doi: 10.1002/14651858.CD010061.pub5.'}, {'pmid': '28395364', 'type': 'DERIVED', 'citation': 'Oncel MY, Eras Z, Uras N, Canpolat FE, Erdeve O, Oguz SS. Neurodevelopmental Outcomes of Preterm Infants Treated with Oral Paracetamol Versus Ibuprofen for Patent Ductus Arteriosus. Am J Perinatol. 2017 Oct;34(12):1185-1189. doi: 10.1055/s-0037-1601564. Epub 2017 Apr 10.'}, {'pmid': '24359938', 'type': 'DERIVED', 'citation': 'Oncel MY, Yurttutan S, Erdeve O, Uras N, Altug N, Oguz SS, Canpolat FE, Dilmen U. Oral paracetamol versus oral ibuprofen in the management of patent ductus arteriosus in preterm infants: a randomized controlled trial. J Pediatr. 2014 Mar;164(3):510-4.e1. doi: 10.1016/j.jpeds.2013.11.008. Epub 2013 Dec 18.'}], 'seeAlsoLinks': [{'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0015687271&QV1=IBUPROFEN', 'label': 'Ibuprofen'}, {'url': 'http://druginfo.nlm.nih.gov/drugportal/ProxyServlet?mergeData=true&objectHandle=DBMaint&APPLICATION_NAME=drugportal&actionHandle=default&nextPage=jsp/drugportal/ResultScreen.jsp&TXTSUPERLISTID=0000103902&QV1=PARACETAMOL', 'label': 'Paracetamol'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.', 'detailedDescription': 'To determine whether oral paracetamol or ibuprofen has a better or same efficacy and tolerance in closure of patent ductus arteriosus in preterm infants.\n\nEighty preterm infants with patent ductus arteriosus will be enrolled in this prospective-randomized study. Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h or oral paracetamol 15 mg/kg per dose every 6 hours.\n\nOne of the following echocardiographic criteria of a duct size \\>1.5 mm, a left atrium-to-aorta ratio \\>1.5, left-to-right shunting of blood, end diastolic reversal of blood flow in the aorta, or poor cardiac function in addition signs of patent ductus arteriosis determined the need of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '10 Days', 'minimumAge': '2 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight below 1250 gram\n* Diagnosed patent ductus arteriosus by Echocardiographic examination\n\nExclusion Criteria:\n\n* Accompanied other congenital cardiac anomalies\n* Urine output of less than 1 ml/kg/h during the preceding 8 h,\n* Serum creatinine level \\>1.6 mg/dl,\n* Platelet count \\<60,000/mm3,\n* Liver failure,\n* Hyperbilirubinemia requiring exchange transfusion\n* Severe intracranial bleeding (Grade III - IV)\n* Intestinal abnormality and necrotising enterocolitis'}, 'identificationModule': {'nctId': 'NCT01536158', 'briefTitle': 'Oral Paracetamol Versus Oral Ibuprofen in Management of Patent Ductus Arteriosus in Preterm Infants: A Randomised Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': "Zekai Tahir Burak Women's Health Research and Education Hospital"}, 'officialTitle': 'Oral Paracetamol Versus Oral Ibuprofen Treatment', 'orgStudyIdInfo': {'id': 'ZTB150212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oral paracetamol', 'description': 'Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours.', 'interventionNames': ['Drug: Oral paracetamol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oral ibuprofen', 'description': 'Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.', 'interventionNames': ['Drug: Oral ibuprofen']}], 'interventions': [{'name': 'Oral paracetamol', 'type': 'DRUG', 'otherNames': ['Calpol'], 'description': 'Patients will receive oral paracetamol 15 mg/kg per dose every 6 hours for 3 days.', 'armGroupLabels': ['Oral paracetamol']}, {'name': 'Oral ibuprofen', 'type': 'DRUG', 'otherNames': ['Pedifen'], 'description': 'Patients will receive oral ibuprofen at an initial dose of 10 mg/kg, followed by 5 mg/kg at 24 and 48 h.', 'armGroupLabels': ['Oral ibuprofen']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06110', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Zekai Tahir Burak Maternity Teaching Hospital, Division of Neonatology', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'Mehmet Yekta Oncel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Zekai Tahir Burak Women's Health Research and Education Hospital", 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Zekai Tahir Burak Maternity and Teaching Hospital', 'investigatorFullName': 'Mehmet Yekta', 'investigatorAffiliation': "Zekai Tahir Burak Women's Health Research and Education Hospital"}}}}