Ignite Creation Date:
2025-12-25 @ 12:58 AM
Ignite Modification Date:
2025-12-28 @ 7:04 PM
Study NCT ID:
NCT01536093
Status:
COMPLETED
Last Update Posted:
2014-08-13
First Post:
2012-01-06
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lamb4122@snu.ac.kr', 'phone': '82-31-787-7301', 'title': 'Dr. Juyoung Lee', 'organization': 'Seoul National University College of Medicine'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.", 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.", 'otherNumAtRisk': 21, 'otherNumAffected': 0, 'seriousNumAtRisk': 21, 'seriousNumAffected': 0}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Urinary Secretary IgA Concentration at 2 Weeks of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '233.8', 'spread': '37.4', 'groupId': 'OG000'}, {'value': '48.3', 'spread': '24.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.006', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks of age', 'unitOfMeasure': 'ng per g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Urinary Secretary IgA Concentration at 1 Week of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '71.4', 'spread': '33.1', 'groupId': 'OG000'}, {'value': '26.5', 'spread': '6.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.043', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week of age', 'unitOfMeasure': 'ng per g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Salivary TGF-beta 1 Concentration at 2 Week of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '39.2', 'spread': '6.3', 'groupId': 'OG000'}, {'value': '69.7', 'spread': '12.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.032', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 week of age', 'unitOfMeasure': 'ug/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Salivary IL-8 Concentration at 2 Weeks of Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '2.58', 'spread': '1.01', 'groupId': 'OG000'}, {'value': '4.90', 'spread': '1.19', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.038', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks of age', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of Urinary Lactoferrin', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '3.51', 'spread': '1.32', 'groupId': 'OG000'}, {'value': '0.98', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.010', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '1 week of age', 'unitOfMeasure': 'ug per g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of Urinary IL-1 Beta', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '21', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'OG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'classes': [{'categories': [{'measurements': [{'value': '55.25', 'spread': '7.12', 'groupId': 'OG000'}, {'value': '91.80', 'spread': '11.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.013', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '2 weeks of age', 'unitOfMeasure': 'ug per g creatinine', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines', 'timeFrame': '1 week of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines', 'timeFrame': '2 weeks of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Time to Reach Full Feeding', 'timeFrame': 'up to 2 months of age', 'description': 'day of life when the baby reaches full enteral feeding, defined as a volume above 120\\~130mL/kg/day', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Total Hospital Admission Duration', 'timeFrame': 'up to 4 months of age', 'description': 'days from admission to discharge from NICU', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Episodes of Culture Positive Sepsis', 'timeFrame': 'from date of randomization up to 4 months of age', 'description': 'numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': "Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2", 'timeFrame': 'from date of randomization up to 4 months of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Episodes of Pneumonia', 'timeFrame': 'from date of randomization up to 4 months of age', 'description': 'numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Development of Bronchopulmonary Dysplasia ≥ Moderate', 'timeFrame': 'up to 4 months of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Development of Intraventricular Hemorrhage ≥ Grade 3', 'timeFrame': 'up to 4 months of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'In-hospital Death', 'timeFrame': 'up to 4 months of age', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Development of Adverse Effects', 'timeFrame': 'from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age', 'description': 'category of adverse effects\n\n1. general - fever or hypothermia, rash\n2. respiratory \\& cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia\n3. gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis\n4. renal - oliguria (urine output \\< 1.0cc/kg/day)\n5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'FG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'absence of maternal colostrum', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum\n\noropharyngeal administration of own mother's colostrum: application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'BG001', 'title': 'Placebo', 'description': "oropharyngeal administration of sterile water\n\noropharyngeal administration of sterile water: application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '26.0', 'spread': '1.4', 'groupId': 'BG001'}, {'value': '26.1', 'spread': '1.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Gestational Age', 'unitOfMeasure': 'weeks', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '862.2', 'spread': '234.8', 'groupId': 'BG000'}, {'value': '842.4', 'spread': '250.4', 'groupId': 'BG001'}, {'value': '849.3', 'spread': '239.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-08-11', 'studyFirstSubmitDate': '2012-01-06', 'resultsFirstSubmitDate': '2014-07-17', 'studyFirstSubmitQcDate': '2012-02-15', 'lastUpdatePostDateStruct': {'date': '2014-08-13', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-07-17', 'studyFirstPostDateStruct': {'date': '2012-02-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-08-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary Secretary IgA Concentration at 2 Weeks of Age', 'timeFrame': '2 weeks of age'}], 'secondaryOutcomes': [{'measure': 'Urinary Secretary IgA Concentration at 1 Week of Age', 'timeFrame': '1 week of age'}, {'measure': 'Salivary TGF-beta 1 Concentration at 2 Week of Age', 'timeFrame': '2 week of age'}, {'measure': 'Salivary IL-8 Concentration at 2 Weeks of Age', 'timeFrame': '2 weeks of age'}, {'measure': 'Concentration of Urinary Lactoferrin', 'timeFrame': '1 week of age'}, {'measure': 'Concentration of Urinary IL-1 Beta', 'timeFrame': '2 weeks of age'}, {'measure': 'Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines', 'timeFrame': '1 week of age'}, {'measure': 'Concentration of Salivary Lactoferrin, Lysozyme, Alpha-lactalbumin and Cytokines', 'timeFrame': '2 weeks of age'}, {'measure': 'Time to Reach Full Feeding', 'timeFrame': 'up to 2 months of age', 'description': 'day of life when the baby reaches full enteral feeding, defined as a volume above 120\\~130mL/kg/day'}, {'measure': 'Total Hospital Admission Duration', 'timeFrame': 'up to 4 months of age', 'description': 'days from admission to discharge from NICU'}, {'measure': 'Episodes of Culture Positive Sepsis', 'timeFrame': 'from date of randomization up to 4 months of age', 'description': 'numbers of documented sepsis events defined as isolation of the microorganism from ≥ 1 blood culture + ≥ 1 clinical symptoms or sign (fever, hypothermia, apnea, bradycardia, hypo-/hyperglycemia)'}, {'measure': "Episodes of Necrotizing Enterocolitis ≥ Bell's Stage 2", 'timeFrame': 'from date of randomization up to 4 months of age'}, {'measure': 'Episodes of Pneumonia', 'timeFrame': 'from date of randomization up to 4 months of age', 'description': 'numbers of documented pneumonia events those accompanied with increased tracheal secretion, increased ventilatory setting and treated with antibiotics'}, {'measure': 'Development of Bronchopulmonary Dysplasia ≥ Moderate', 'timeFrame': 'up to 4 months of age'}, {'measure': 'Development of Intraventricular Hemorrhage ≥ Grade 3', 'timeFrame': 'up to 4 months of age'}, {'measure': 'In-hospital Death', 'timeFrame': 'up to 4 months of age'}, {'measure': 'Development of Adverse Effects', 'timeFrame': 'from the start date of oropharyngeal administration of colostrum or sterile water to 1 week of age', 'description': 'category of adverse effects\n\n1. general - fever or hypothermia, rash\n2. respiratory \\& cardiovascular - apnea, tachypnea, desaturation, hypotension, bradycardia, tachycardia\n3. gastrointestinal - abdominal distension, bilious gastric remain, vomiting, bloody stool, necrotizing enterocolitis\n4. renal - oliguria (urine output \\< 1.0cc/kg/day)\n5. laboratory - hypo-/hyper-natremia, acidosis, hypercarbia'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Extremely Low Gestational Age Newborn', 'Premature Infant']}, 'referencesModule': {'references': [{'pmid': '25624376', 'type': 'DERIVED', 'citation': 'Lee J, Kim HS, Jung YH, Choi KY, Shin SH, Kim EK, Choi JH. Oropharyngeal colostrum administration in extremely premature infants: an RCT. Pediatrics. 2015 Feb;135(2):e357-66. doi: 10.1542/peds.2014-2004.'}]}, 'descriptionModule': {'briefSummary': 'Colostrum is rich in cytokines and other immune agents that may provide immunomodulatory protection against nosocomial infection in extremely premature infants. However, most of them could not proceed enteral feedings due to clinical instability in the first few days. Recent studies supports oropharyngeal administration as a potentially safe and effective delivery method for immunologic benefits and only small amount of colostrum could be administrated for immune therapy for extremely premature babies. The purpose of this study is to determine the beneficial effects of oropharyngeal administration of colostrum for immunologic aspects in extremely low gestational age infants and evaluated the safety of this method to extremely premature infants in the first few days of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '96 Hours', 'minimumAge': '48 Hours', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* premature infant with a gestational age less than 28 weeks born at Seoul National University Hospital and admit to the Seoul National University Children's Hospital NICU immediately after birth\n* parents of the infant signed to the informed consent form with voluntary agreement\n\nExclusion Criteria:\n\n* infants with major congenital anomalies or chromosomal syndromes\n* infants of mothers not willing to provide colostrum in the first week of life\n* infants of mothers with known infectious diseases that may be transmitted through the breast milk such as HIV, hepatitis C or active TB"}, 'identificationModule': {'nctId': 'NCT01536093', 'briefTitle': 'Oropharyngeal Administration of Colostrum to Extremely Low Gestational Age Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'orgStudyIdInfo': {'id': 'OAC-01-ELGAN'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Colostrum', 'description': "oropharyngeal administration of own mother's colostrum", 'interventionNames': ["Other: oropharyngeal administration of own mother's colostrum"]}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'oropharyngeal administration of sterile water', 'interventionNames': ['Other: oropharyngeal administration of sterile water']}], 'interventions': [{'name': "oropharyngeal administration of own mother's colostrum", 'type': 'OTHER', 'description': "application of 0.2 mL of colostrum to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.", 'armGroupLabels': ['Colostrum']}, {'name': 'oropharyngeal administration of sterile water', 'type': 'OTHER', 'description': "application of 0.2 mL of sterile water to the infant's oropharyngeal mucosa every 3 hours for 3 days from the postnatal 48 to 96 hours.", 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110-744', 'city': 'Seoul', 'country': 'South Korea', 'facility': "Seoul National University Children's Hospital", 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Han-Suk Kim', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}