Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-31 @ 9:35 AM
Study NCT ID:
NCT07305935
Status:
RECRUITING
Last Update Posted:
2025-12-26
First Post:
2025-12-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'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': 'D002110', 'term': 'Caffeine'}, {'id': 'D010166', 'term': 'Palliative Care'}], 'ancestors': [{'id': 'D014970', 'term': 'Xanthines'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011688', 'term': 'Purinones'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 236}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-18', 'studyFirstSubmitDate': '2025-12-05', 'studyFirstSubmitQcDate': '2025-12-18', 'lastUpdatePostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acute Kidney Injury', 'timeFrame': '14 days', 'description': 'Incidence of AKI within the first 14 days of life.'}], 'secondaryOutcomes': [{'measure': 'Duration of Acute Kidney Injury', 'timeFrame': 'Up to 30 days', 'description': 'Time duration between onset of AKI and resolution.'}, {'measure': 'Length of Hospital Stay', 'timeFrame': 'Up to 30 days', 'description': 'Time duration from admission to discharge.'}, {'measure': 'Mortality', 'timeFrame': 'Up to 30 days', 'description': 'Mortality will be labelled when a patient expires during a hospital stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth']}, 'descriptionModule': {'briefSummary': 'Recent observational data point towards a reduced incidence of acute kidney injury (AKI) with early caffeine use, but high-quality randomized controlled trials comparing early caffeine initiation to supportive therapy alone are lacking. This study aims to fill this critical gap by comparing the efficacy of early caffeine administration versus supportive therapy in preventing AKI in preterm neonates.', 'detailedDescription': 'There remains a debate about whether early initiation of caffeine therapy reduces the incidence and severity of AKI in preterm neonates compared to standard supportive care or not. Therefore, the incidence of AKI in preterm neonates will be compared between those receiving early caffeine therapy versus those receiving standard supportive therapy. The findings of this study would not only be a valuable addition to the statistics but also help clinicians to go for a better option in preterm neonates to prevent AKI, resulting in reducing the duration of mechanical ventilation, length of hospital stays, and all-cause neonatal mortality.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neonates of any gender\n* Neonates with gestational age \\<32 weeks\n* Admitted within 6 hours of birth\n\nExclusion Criteria:\n\n* Major congenital anomalies\n* Severe birth asphyxia (Apgar \\<3 at 10 min)\n* Pre-existing renal anomalies'}, 'identificationModule': {'nctId': 'NCT07305935', 'briefTitle': 'Comparison of Early Caffeine Administration Vs Supportive Therapy in Preventing Acute Kidney Injury', 'organization': {'class': 'OTHER', 'fullName': 'RESnTEC, Institute of Research'}, 'officialTitle': 'Comparative Efficacy of Early Caffeine Administration Versus Supportive Therapy in Preventing Acute Kidney Injury in Preterm Neonates', 'orgStudyIdInfo': {'id': 'DR-NAZIA-MULTAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Caffeine Group', 'description': 'Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.', 'interventionNames': ['Drug: Caffeine']}, {'type': 'EXPERIMENTAL', 'label': 'Supportive Care Group', 'description': 'Neonates will be given supportive care without caffeine', 'interventionNames': ['Drug: Supportive care']}], 'interventions': [{'name': 'Caffeine', 'type': 'DRUG', 'description': 'Neonates will receive caffeine citrate (IV or enteral) in 20 mg/kg loading dose within 24 hours of life, followed by a 5 mg/kg/day maintenance dose.', 'armGroupLabels': ['Early Caffeine Group']}, {'name': 'Supportive care', 'type': 'DRUG', 'description': 'Neonates will be given supportive care without caffeine.', 'armGroupLabels': ['Supportive Care Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66000', 'city': 'Multan', 'state': 'Punjab Province', 'status': 'RECRUITING', 'country': 'Pakistan', 'contacts': [{'name': 'Nazia Fatima, FCPS', 'role': 'CONTACT', 'email': 'dr.nazee@gmail.com', 'phone': '\u202a+923334179233'}, {'name': 'Rabia Saleem, PCPS', 'role': 'CONTACT', 'email': 'dr_rabiasaleem@live.com', 'phone': '+923337610846'}, {'name': 'Nazia Fatima', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rabia Saleem', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "The Children's Hospital & The Institute of Child Health", 'geoPoint': {'lat': 30.19679, 'lon': 71.47824}}], 'centralContacts': [{'name': 'Nazia Fatima, FCPS', 'role': 'CONTACT', 'email': 'dr.nazee@gmail.com', 'phone': '+923334179233'}, {'name': 'Rabia Saleem, FCPS', 'role': 'CONTACT', 'email': 'dr_rabiasaleem@live.com', 'phone': '+923337610846'}], 'overallOfficials': [{'name': 'Nazia Fatima, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Children's Hospital & The Institute of Child Health, Multan"}, {'name': 'Rabia Saleem, FCPS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "The Children's Hospital & The Institute of Child Health, Multan"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data can be shared on a reasonable request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammad Aamir Latif', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Research Consultant', 'investigatorFullName': 'Muhammad Aamir Latif', 'investigatorAffiliation': 'RESnTEC, Institute of Research'}}}}