Ignite Creation Date:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-29 @ 2:54 AM
Study NCT ID:
NCT04424667
Status:
COMPLETED
Last Update Posted:
2023-09-22
First Post:
2020-06-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000071074', 'term': 'Neonatal Sepsis'}], 'ancestors': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Parallel assignment'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 211}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-21', 'studyFirstSubmitDate': '2020-06-03', 'studyFirstSubmitQcDate': '2020-06-05', 'lastUpdatePostDateStruct': {'date': '2023-09-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Microbiological proven late onset sepsis rate', 'timeFrame': 'From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks', 'description': 'Incidence of Microbiological proven late onset sepsis expressed as a percentage'}], 'secondaryOutcomes': [{'measure': 'Central line associated bloodstream infections (CLABSI) rate', 'timeFrame': 'From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks', 'description': 'Number of CLABSI events per 1000 catheter-days'}, {'measure': 'Necrotizing enterocolitis (NEC) and/or microbiological proven late onset sepsis rate', 'timeFrame': 'From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks', 'description': 'Incidence of NEC nad late onset sepsis as a percentage'}, {'measure': 'Mortality rate', 'timeFrame': 'From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks', 'description': 'Percentage of preterm infant died during the study'}, {'measure': 'Oxygen supplementation', 'timeFrame': 'Assessed up to 24 weeks', 'description': 'Percentage of infants with respiratory assistance with fraction of inspired oxygen greater than 0.21 at 36 weeks postmenstrual age'}, {'measure': 'Stage 3-5 Retinopathy', 'timeFrame': 'From the time and day of randomization until the date of discharge from the neonatal unit, assessed up to 24 weeks', 'description': 'Percentage of infants diagnosed with retinopathy by the ophthalmologist'}, {'measure': 'Growth velocity', 'timeFrame': 'Assessed up to 24 weeks', 'description': 'Growth calculated as the weight gain in g/kg/day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['neonatal sepsis', 'extremely low birth weight infant', 'donor milk', 'HTST pasteurization', 'Holder pasteurization'], 'conditions': ['Late-Onset Neonatal Sepsis']}, 'descriptionModule': {'briefSummary': 'Randomized double-blind clinical trial to compare the incidence of microbiological proven late onset sepsis in extremely preterm infants (\\<1000 grams) that are supplemented with donor milk pasteurized by High Temperature Short Time (HTST) method versus the Holder method.', 'detailedDescription': 'Donor milk pasteurized by an innovative High Temperature Short Time (HTST) system (patented by researchers) retains more immune and trophic compounds than pasteurized milk by traditional Holder method. These compounds are related to the protection conferred by breast milk against nosocomial sepsis and necrotizing enterocolitis in preterm infants, so it would be of interest to study if there is a clinical benefit in these patients when health professionals are supplementing with donor milk pasteurized by both methods.\n\nThe purpose of this study is to compare the incidence of microbiological proven late onset sepsis in newborns under 1000 grams that in the first 28 days of life need to be supplemented with donor milk pasteurized by HTST method versus the Holder method.\n\nThis is a randomized double-blind clinical trial with parallel assignment. A total of 305 premature babies with a birth weight of less than 1000 grams will be recruited, admitted to the Neonatology Services of the Hospital 12 de Octubre and the Hospital de La Paz and meet the inclusion criteria. Half of the patients will be supplemented exclusively with donor milk pasteurized by the HTST system and the other half with pasteurized milk by the Holder method. Linear generalized models will be used for longitudinal data analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '28 Days', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria (all criteria are necessary) :\n\n* Infants weighing 1000 grams or less at birth\n* Infants born or transferred before the third day of life to the participating centers\n* Start enteral feeding in the first week of life\n* Receive any amount of donor milk in the first 28 days of life\n* Informed consent signed by parents or legal guardians\n\nExclusion Criteria:\n\n* Language barrier\n* Infants with chromosomopathies\n* Infants with major congenital malformations\n* Infants with severe asphyxiation (cord pH or first arterial pH \\<7)\n* Infants included in another clinical trial that modifies nutritional management\n* Infants who previously fed with formula\n\nPost-randomization exclusion criteria:\n\n\\- Randomized infant who do not fulfill inclusion criteria'}, 'identificationModule': {'nctId': 'NCT04424667', 'briefTitle': 'Clinical Impact of Donor Milk Pasteurized by HTST Treatment in Preterm Infants', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario 12 de Octubre'}, 'officialTitle': 'Clinical and Economic Impact of Supplementation With Donor Milk Pasteurized by HTST Method Versus Holder Method in Extremely Birth Weight Preterm Infants. Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Neo-HTST'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Holder pasteurization', 'description': 'Donor milk pasteurized by Holder method (62.5ºC, 30 minutes)', 'interventionNames': ['Other: donor milk']}, {'type': 'EXPERIMENTAL', 'label': 'HTST pasteurization', 'description': 'Donor milk pasteurized by High Temperature Short Time (HTST) method (72ºC, 15 seconds)', 'interventionNames': ['Other: donor milk']}], 'interventions': [{'name': 'donor milk', 'type': 'OTHER', 'description': 'pasteurized donor milk', 'armGroupLabels': ['HTST pasteurization', 'Holder pasteurization']}]}, 'contactsLocationsModule': {'locations': [{'zip': '28041', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital 12 de Octubre', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Hospital Universitario La Paz', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}], 'overallOfficials': [{'name': 'Carmen Rosa Pallas Alonso', 'role': 'STUDY_CHAIR', 'affiliation': 'Hospital Universitario 12 de Octubre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Carmen Rosa Pallas', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Neonatology Service, MD, PhD', 'investigatorFullName': 'Carmen Rosa Pallas', 'investigatorAffiliation': 'Hospital Universitario 12 de Octubre'}}}}