Ignite Creation Date:
2025-12-24 @ 9:47 PM
Ignite Modification Date:
2026-01-10 @ 4:08 PM
Study NCT ID:
NCT06534632
Status:
COMPLETED
Last Update Posted:
2024-08-05
First Post:
2024-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-01', 'studyFirstSubmitDate': '2024-07-29', 'studyFirstSubmitQcDate': '2024-07-31', 'lastUpdatePostDateStruct': {'date': '2024-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of infants with late-onset sepsis in each group', 'timeFrame': 'Up to 40 weeks corrected gestational age', 'description': 'Positive blood cultures collected or clinical symptoms of sepsis after 72 hours of age'}], 'secondaryOutcomes': [{'measure': 'Mortality', 'timeFrame': 'Up to 40 weeks corrected gestational age', 'description': 'Number of deaths in each group'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prematurity']}, 'descriptionModule': {'briefSummary': "This clinical trial aimed to evaluate the efficacy of the oral mother's colostrum administration for preventing late-onset sepsis in premature neonates during their stay in the neonatal intensive care unit. The investigators hypothesized that premature infants who receive oral mother's colostrum would have a lower incidence of late-onset sepsis and better hospital outcomes, compared to infants who receive a placebo.", 'detailedDescription': "The study was a randomized clinical trial, performed on very-low-birthweight premature newborns admitted to the neonatal intensive care unit of Mataria Teaching Hospital after considering exclusion criteria.\n\nThe enrolled newborns were randomly subdivided into two groups (1:1). The colostrum group received their mother's colostrum, and the placebo group received placebo (sterile water) using a standardized protocol. The newborns received 0.2 mL of the colostrum or placebo orally using a swab directed backward into the oropharynx (0.1 mL on either side of the oral cavity), starting during the first 24 hours of life and lasting for 5 days. Vital signs were carefully monitored throughout the procedure. Dosing was provided every 6 hours during the study period.\n\nAll infants underwent follow-up from birth until discharge or death whichever came first. Neonates were evaluated for occurrence of late-onset sepsis, death, and other clinical outcomes."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '24 Hours', 'minimumAge': '1 Hour', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Very-low-birth-weight preterm newborns admitted to the neonatal intensive care unit within 24 hours after delivery\n* Neonates with gestational age ≤ 34 weeks and weight ≤ 1500 grams\n\nExclusion Criteria:\n\n* Infants with severe gastrointestinal malformations.\n* Infants with serious congenital anomalies or chromosomal abnormalities.\n* Infants with signs of early-onset sepsis.\n* Any contraindications for breastfeeding because of maternal conditions including active tuberculosis or AIDS, or treatment with medications excreted in breast milk.'}, 'identificationModule': {'nctId': 'NCT06534632', 'briefTitle': 'Oral Care With Colostrum for Preventing Late-onset Sepsis in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'General Organization for Teaching Hospitals and Institutes'}, 'officialTitle': "Does Oral Care With Mother's Colostrum Reduce the Risk of Late-Onset Sepsis in Preterm Infants", 'orgStudyIdInfo': {'id': 'HM000142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colostrum group', 'description': "The interventional group received their mother's colostrum through the oropharyngeal route beginning within the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours", 'interventionNames': ["Other: Mother's colostrum"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo group received sterile water through the oropharyngeal route beginning in the first 24 hours of birth and for 5 days at a dose of 0.2 mL/6 hours', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': "Mother's colostrum", 'type': 'OTHER', 'description': "Oropharyngeal administration of mother's colostrum", 'armGroupLabels': ['Colostrum group']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Oropharyngeal administration of sterile water', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Mataria Teaching Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Marwa Taha, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt'}, {'name': 'Mai M Mostafa, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt'}, {'name': 'Fifi Helmy, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt'}, {'name': 'Sohaila A Abd El-Halim, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Mataria Teaching Hospital, General Organization for Teaching Hospitals and Institutes, Egypt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'General Organization for Teaching Hospitals and Institutes', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Fellow of Pediatrics (Principal Investigator)', 'investigatorFullName': 'Marwa Taha, MD', 'investigatorAffiliation': 'General Organization for Teaching Hospitals and Institutes'}}}}