Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2026-01-02 @ 9:38 AM
Study NCT ID:
NCT06501404
Status:
COMPLETED
Last Update Posted:
2024-07-15
First Post:
2024-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}], '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'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D044382', 'term': 'Population Groups'}], 'ancestors': [{'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 583}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2020-03-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-12', 'studyFirstSubmitDate': '2024-06-19', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-01-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of necrotizing enterocolitis and all-cause mortality', 'timeFrame': 'From birth until three months', 'description': 'The primary objective of the study was to determine the incidence of necrotizing enterocolitis (modified Bell classification stages II and III) and all-cause mortality during hospital stay in both intervention groups.'}], 'secondaryOutcomes': [{'measure': 'Intestinal colonization by administered strains', 'timeFrame': 'From birth until three months'}, {'measure': 'Incidence of Late Onset Sepsis', 'timeFrame': 'From birth until three months', 'description': 'Incidence of Late Onset Sepsis. In accordance with the criteria used by the Castrillo Group for neonatal infections in Spain (compatible clinical symptoms, elevation of water-phase reactants and positive blood culture)'}, {'measure': 'Time to complete enteral nutrition', 'timeFrame': 'From birth until three months', 'description': 'Time to reach complete enteral nutrition 140 ml/kg/day'}, {'measure': 'Days of Central Vascular Catheter', 'timeFrame': 'From birth until three months'}, {'measure': 'Length of hospital stay', 'timeFrame': 'From birth until three months', 'description': 'Days of hospital stay'}, {'measure': 'Weight change', 'timeFrame': 'From birth until three months'}, {'measure': 'Incidence of Bronchopulmonary Dysplasia', 'timeFrame': 'From birth until three months'}, {'measure': 'Incidence of patent ductus arteriosus', 'timeFrame': 'From birth until three months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Premature Infants', 'Necrotizing Enterocolitis']}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to assess the impact of two different doses of a mixture of probiotics from two strains isolated in human milk on the incidence of severe necrotizing enterocolitis (NEC) and death among preterm infants of gestational age less than or equal to 32 weeks of gestation and weighing between 750 and 1500 g.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '72 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Preterm infants of gestational age less than 33 weeks of gestation with birth weight below 1500 g, admitted to the Neonatology Unit.\n* Premature newborns who meet the above criteria and receive enteral feeding (mother breast milk, donors milk and/or premature formula) from the amount of 5 ml/kg/day.\n\nExclusion Criteria:\n\n* Any clinical circumstance that prevents the initiation of enteral nutrition in the first 72 hours of life.\n* Chromosomopathies and complex fetal malformations, incompatible with enteral nutrition in the first 72 hours of life.\n* Non-acceptance of informed consent to participate in the study by the parents or legal guardians of the newborn.'}, 'identificationModule': {'nctId': 'NCT06501404', 'briefTitle': 'PREMAPROB. Probiotics to Prevent Necrotizing Enterocolitis', 'organization': {'class': 'OTHER', 'fullName': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental'}, 'officialTitle': 'Effects of Probiotic Supplementation During the Neonatal Period on the Preterm Infant', 'orgStudyIdInfo': {'id': 'PN01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High dose of probiotic mixture', 'description': 'A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains', 'interventionNames': ['Dietary Supplement: High dose group']}, {'type': 'EXPERIMENTAL', 'label': 'Low dose of probiotic mixture', 'description': 'A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains', 'interventionNames': ['Dietary Supplement: Low dose group']}], 'interventions': [{'name': 'High dose group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily high dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x109 CFU of each of the strains', 'armGroupLabels': ['High dose of probiotic mixture']}, {'name': 'Low dose group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily low dose of a mixture of probiotics (Lactobacillus Fermentum CECT 5716 and Bifidobacterium breve CECT 7263), was given orally starting in the first 72 hours of life, until 36+6 weeks of postmenstrual age or discharge The total dose was 1x106 CFU of each of the strains', 'armGroupLabels': ['Low dose of probiotic mixture']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18012', 'city': 'Granada', 'country': 'Spain', 'facility': 'Hospital Virgen de las Nieves', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'José Antonio Hurtado Suazo', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Virgen de las Nieves', 'class': 'OTHER'}, {'name': 'Hospital Regional de Malaga', 'class': 'OTHER'}, {'name': 'Hospital of Jaen', 'class': 'OTHER'}, {'name': 'Hospital Costa del Sol', 'class': 'OTHER'}, {'name': 'Hospital Universitario Torrecárdenas', 'class': 'OTHER'}, {'name': 'Hospital Universitario Virgen Macarena', 'class': 'OTHER'}, {'name': 'Complejo Hospitalario de Especialidades Juan Ramón Jimenez', 'class': 'OTHER'}, {'name': 'Hospital Universitario de Valme', 'class': 'OTHER'}, {'name': 'Hospitales Universitarios Virgen del Rocío', 'class': 'OTHER'}, {'name': 'Hospital Universitario Puerta del Mar', 'class': 'OTHER'}, {'name': 'Hospital General Universitario Santa Lucia', 'class': 'OTHER'}, {'name': 'Hospital del SAS de Jerez', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Head of Neonatolgy Division. University Hospital Virgen de las Nieves', 'investigatorFullName': 'José Antonio Hurtado Suazo', 'investigatorAffiliation': 'Fundación Pública Andaluza para la Investigación Biomédica Andalucía Oriental'}}}}