Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:07 AM
Study NCT ID:
NCT07480434
Status:
COMPLETED
Last Update Posted:
2026-03-18
First Post:
2026-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 180}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-14', 'studyFirstSubmitDate': '2026-03-14', 'studyFirstSubmitQcDate': '2026-03-14', 'lastUpdatePostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal Sepsis', 'timeFrame': '7 Days', 'description': 'Neonatal Sepsis Score was used to assess clinical severity of sepsis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Clinical sepsis', 'Enteral Lactoferrin', 'Preterm neonates'], 'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Lactoferrin (LF) is a multifunctional glycoprotein and is naturally present in various body secretions, including human milk, tears, saliva, airway mucus, and the secondary granules of neutrophils 1-2. It plays a crucial role in innate infant immunity by exerting immunomodulatory, antimicrobial and anti-inflammatory effects. The biochemical and molecular properties of LF, such as ferric iron transport, enzymatic activity, and nuclear binding for transcriptional regulation, essentially make it a versatile defense molecule in host-pathogen interactions. Sepsis remains leading cause of morbidity and mortality in vulnerable populations , placing significant burdens on healthcare systems and families. Despite advancements in neonatal care, strategies to effectively reduce these risks remain limited, necessitating a focus on prophylactic interventions that are safe and evidence-based. This study is designed to fill the gaps of possible preventive strategy for sepsis among premature babies and to evaluate the effectiveness of enteral lactoferrin supplementation in decreasing the clinical sepsis among preterm neonates.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '37 Weeks', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm Neonates (Neonates who are born before the completion of 37 weeks of pregnancy)\n* Low birth weight infants less than 2500 grams at birth\n* Recruited within the first 72 hours after birth\n* Admitted to the Neonatology department\n\nExclusion Criteria:\n\n* Neonates born with congenital anomalies\n* Newborns with infections identified at the time of birth, signs of infection on admission (fever, respiratory problems, etc.), or infection detected by the physician.'}, 'identificationModule': {'nctId': 'NCT07480434', 'briefTitle': 'Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates', 'organization': {'class': 'OTHER', 'fullName': 'King Edward Medical University'}, 'officialTitle': 'Role of Enteral Lactoferrin as an Adjuvant for Prevention of Sepsis Among Preterm Neonates', 'orgStudyIdInfo': {'id': '174'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Group A participants with standard treatment', 'description': 'Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. Group A is control group with standard treatment only'}, {'type': 'EXPERIMENTAL', 'label': 'Group B participants', 'description': 'Preterm neonates admitted to the neonatology department during the study period were randomly allocated into two groups. In Group B bovine lactoferrin was given orally at a dose of 150 mg/kg/day once within 72 hours of birth.', 'interventionNames': ['Biological: Bovine Lactoferrin Supplement']}], 'interventions': [{'name': 'Bovine Lactoferrin Supplement', 'type': 'BIOLOGICAL', 'description': 'Group B participants were given bovine lactoferrin orally at a dose of 150 mg/kg/day once within 72 hours of birth', 'armGroupLabels': ['Group B participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '54000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'King Edward Medical University Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zartash Sial Paeds Med', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Zartash Sial Paeds Med', 'investigatorAffiliation': 'King Edward Medical University'}}}}