Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-28 @ 8:58 PM
Study NCT ID:
NCT01603368
Status:
COMPLETED
Last Update Posted:
2024-08-13
First Post:
2012-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Prophylactic Probiotics to Extremely Low Birth Weight Prematures
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005183', 'term': 'Failure to Thrive'}, {'id': 'D020345', 'term': 'Enterocolitis, Necrotizing'}, {'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D001835', 'term': 'Body Weight'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D004760', 'term': 'Enterocolitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'thomas.abrahamsson@liu.se', 'phone': '+46.10.1030000', 'title': 'Thomas Abrahamsson, MD PhD', 'organization': 'University of Linköping'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'From birth until 36+0 weeks corrected postmenstrual age', 'eventGroups': [{'id': 'EG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 0, 'seriousNumAtRisk': 68, 'deathsNumAffected': 5, 'seriousNumAffected': 55}, {'id': 'EG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 0, 'seriousNumAtRisk': 66, 'deathsNumAffected': 5, 'seriousNumAffected': 52}], 'seriousEvents': [{'term': 'Infection by the probiotic bacterium', 'notes': 'Positive culture with Lactobacillus reuteri from a normally sterile location (typically blood, cerebrospinal fluid).', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Severe morbidity or death', 'notes': 'This compound measure reports if any of the following occurred:\n\nNecrotizing enterocolitis stage 2 - 3 Culture proven sepsis Bronchopulmonary dysplasia ROP, grade 3-5 IVH, grade 3-4 Periventricular leukomalacia Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numAffected': 55}, {'groupId': 'EG001', 'numAtRisk': 66, 'numAffected': 52}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to Establish Full Enteral Feeds', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '11', 'upperLimit': '23'}, {'value': '15', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '20'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Birth to gestational week 36+0', 'description': 'The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Six infants - Four allocated to receive L. reuteri and two allocated to the placebo group died before reaching full enteral feeding and were not included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Days With Halted Feeding Due to Food Intolerance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '9.5'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '4', 'upperLimit': '10'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Birth to gestational week 36', 'description': 'Episode with food intolerance. Retention volume\\> food volume given the last 2 hours (retention checked routinely every 4 hours) and/or clinical signs consistent with necrotizing enterocolitis (reduced general condition and inflated abdomen). The number of such events will also be indicated.', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Stools', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '69.6', 'groupId': 'OG000', 'lowerLimit': '64.1', 'upperLimit': '75.1'}, {'value': '69.9', 'groupId': 'OG001', 'lowerLimit': '63.8', 'upperLimit': '75.9'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Recorded over the first four weeks', 'unitOfMeasure': 'number of stools', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Only infants with complete records of stools during the first four weeks are included'}, {'type': 'SECONDARY', 'title': 'Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived.', 'timeFrame': 'Birth to gw 36+0', 'description': 'Specifies the number of full days the child has lived.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Weight Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.88', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '-0.88', 'spread': '0.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Birth to gw 36+0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Necrotizing Enterocolitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Birth to gw 36+0', 'description': 'Bell´s criteria II-III', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Sepsis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Birth to gw 36+0', 'description': 'Blood culture positive sepsis', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Bronchopulmonary Dysplasia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Gw 36+0', 'description': 'Need of oxygen or CPAP/ventilator at gw 36+0', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Only patients surviving to gestational week 36+0 could be assessed for the diagnosis.'}, {'type': 'SECONDARY', 'title': 'Weight Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.14', 'spread': '1.07', 'groupId': 'OG000'}, {'value': '-1.25', 'spread': '0.95', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Weight Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.40', 'spread': '1.30', 'groupId': 'OG000'}, {'value': '-0.24', 'spread': '1.10', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.02', 'spread': '1.00', 'groupId': 'OG000'}, {'value': '-1.20', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '62', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.67', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-1.96', 'spread': '1.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Length Gain (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.44', 'spread': '1.65', 'groupId': 'OG000'}, {'value': '-1.34', 'spread': '1.52', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Head Circumference Growth (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}, {'value': '62', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.92', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '-1.11', 'spread': '0.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Head Circumference Growth (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '64', 'groupId': 'OG000'}, {'value': '63', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.21', 'spread': '0.85', 'groupId': 'OG000'}, {'value': '-1.73', 'spread': '0.91', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.001', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': "Student's t-test"}], 'paramType': 'MEAN', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Head Circumference Growth (SD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.57', 'spread': '1.29', 'groupId': 'OG000'}, {'value': '-0.79', 'spread': '1.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.', 'unitOfMeasure': 'change in standard deviations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Neurological Development', 'timeFrame': 'At 2 years corrected age', 'description': 'Bayleys´s test by psychologist', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-08'}, {'type': 'SECONDARY', 'title': 'Neurological Development Impairment', 'timeFrame': 'At 2 years corrected age', 'description': 'A composite of several outcomes: impaired cognition at the Bayleys´test, cerebral palsy, blindness and deafness, divided into normal, mild, moderate and severe. Mild -1SD to -2SD, Moderate \\<-2D to 3 SD and Severe \\<3SD', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants', 'anticipatedPostingDate': '2024-08'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lactobacillus Reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day\n\nLactobacillus reuteri: Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri\n\nPlacebo: Oil drops without Lactobacillus reuteri'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}, {'groupId': 'FG001', 'numSubjects': '66'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Extremely preterm infants with a birth weight \\<1000 g were recruited within 72 hours after birth in two level 3 NICUs .', 'preAssignmentDetails': 'Inclusion should be completed to allow first dose of study product to be administered within 72 hours from birth.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '134', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Probiotic', 'description': 'Lactobacillus reuteri'}, {'id': 'BG001', 'title': 'Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.5', 'spread': '1.2', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '1.3', 'groupId': 'BG001'}, {'value': '25.5', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Postmenstrual weeks', 'unitOfMeasure': 'age in postmenstrual weeks at birth', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Birth weight', 'classes': [{'categories': [{'measurements': [{'value': '731', 'spread': '129', 'groupId': 'BG000'}, {'value': '740', 'spread': '148', 'groupId': 'BG001'}, {'value': '735', 'spread': '138', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'gram', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 134}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-17', 'studyFirstSubmitDate': '2012-05-18', 'resultsFirstSubmitDate': '2019-01-21', 'studyFirstSubmitQcDate': '2012-05-21', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-06', 'studyFirstPostDateStruct': {'date': '2012-05-22', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to Establish Full Enteral Feeds', 'timeFrame': 'Birth to gestational week 36+0', 'description': 'The age of the infants in days when the infant receive 150 ml/kg/day via enteral feeding for the first time.'}], 'secondaryOutcomes': [{'measure': 'Days With Halted Feeding Due to Food Intolerance', 'timeFrame': 'Birth to gestational week 36', 'description': 'Episode with food intolerance. Retention volume\\> food volume given the last 2 hours (retention checked routinely every 4 hours) and/or clinical signs consistent with necrotizing enterocolitis (reduced general condition and inflated abdomen). The number of such events will also be indicated.'}, {'measure': 'Number of Stools', 'timeFrame': 'Recorded over the first four weeks'}, {'measure': 'Time Until Birth Weight is Regained. Specifies the Number of Full Days the Child Has Lived.', 'timeFrame': 'Birth to gw 36+0', 'description': 'Specifies the number of full days the child has lived.'}, {'measure': 'Weight Gain (SD)', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Mortality', 'timeFrame': 'Birth to gw 36+0'}, {'measure': 'Necrotizing Enterocolitis', 'timeFrame': 'Birth to gw 36+0', 'description': 'Bell´s criteria II-III'}, {'measure': 'Sepsis', 'timeFrame': 'Birth to gw 36+0', 'description': 'Blood culture positive sepsis'}, {'measure': 'Bronchopulmonary Dysplasia', 'timeFrame': 'Gw 36+0', 'description': 'Need of oxygen or CPAP/ventilator at gw 36+0'}, {'measure': 'Weight Gain (SD)', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Weight Gain (SD)', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Length Gain (SD)', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Length Gain (SD)', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Length Gain (SD)', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Head Circumference Growth (SD)', 'timeFrame': 'At 14th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Head Circumference Growth (SD)', 'timeFrame': 'At 28th day of life', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Head Circumference Growth (SD)', 'timeFrame': 'At gestational week 36+0', 'description': 'In this analysis, the difference in standard deviation score (delta z-scores) for weight, height and head circumference at birth and 14 and 28 days and gestational week 36+0 will be calculated. At gestational week 36+0 also absolute values will be analyzed. A positive delta z-score indicates faster growth than the growth chart would predict.'}, {'measure': 'Neurological Development', 'timeFrame': 'At 2 years corrected age', 'description': 'Bayleys´s test by psychologist'}, {'measure': 'Neurological Development Impairment', 'timeFrame': 'At 2 years corrected age', 'description': 'A composite of several outcomes: impaired cognition at the Bayleys´test, cerebral palsy, blindness and deafness, divided into normal, mild, moderate and severe. Mild -1SD to -2SD, Moderate \\<-2D to 3 SD and Severe \\<3SD'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Probiotics', 'Lactobacillus reuteri', 'Prematures', 'Enteral feeding', 'Motility', 'Necrotizing enterocolitis', 'Sepsis', 'Weight'], 'conditions': ['Feeding; Difficult, Newborn', 'Growth Failure', 'Necrotizing Enterocolitis', 'Sepsis']}, 'referencesModule': {'references': [{'pmid': '33923278', 'type': 'DERIVED', 'citation': 'Spreckels JE, Wejryd E, Marchini G, Jonsson B, de Vries DH, Jenmalm MC, Landberg E, Sverremark-Ekstrom E, Marti M, Abrahamsson T. Lactobacillus reuteri Colonisation of Extremely Preterm Infants in a Randomised Placebo-Controlled Trial. Microorganisms. 2021 Apr 24;9(5):915. doi: 10.3390/microorganisms9050915.'}, {'pmid': '33763652', 'type': 'DERIVED', 'citation': 'Marti M, Spreckels JE, Ranasinghe PD, Wejryd E, Marchini G, Sverremark-Ekstrom E, Jenmalm MC, Abrahamsson T. Effects of Lactobacillus reuteri supplementation on the gut microbiota in extremely preterm infants in a randomized placebo-controlled trial. Cell Rep Med. 2021 Feb 22;2(3):100206. doi: 10.1016/j.xcrm.2021.100206. eCollection 2021 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis, and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition.\n\nThe aim of the study is to evaluate whether supplementation with the probiotic bacterium Lactobacillus reuteri DSM 17938 daily to premature infants with extremely low birth weight increases feeding tolerance to breast milk and thereby improves nutrition, increases growth and reduces serious complications and mortality in this population. Beyond this, possible mechanisms underlying these effects will be analyzed in stool, breast milk and blood samples.', 'detailedDescription': 'RATIONALE Mortality and incidence of severe complications is still high among extremely premature infants. Common causes of severe complications in this population are poor nutrition, necrotizing enterocolitis (NEC), and severe infections. Feeding intolerance is also a common problem resulting in prolonged need for intravenous lines and poor nutrition. There is scientific evidence that dietary supplements with probiotics may have an effect on these manifestations.\n\nLactobacillus reuteri is a well studied probiotic bacterium that has been tested in several clinical studies in premature infants and older children, and the results of these studies and animal studies suggest that this bacterium may also have an effect on growth and mortality in extremely premature infants. Lactobacillus reuteri reduces colonization with pathogenic microbes, stimulates gastric and intestinal motility and shortens hospital stay in moderately premature infants. In animal models, L. reuteri also induces anti-inflammatory immune responses, reduces the symptoms of inflammatory bowel disease and the incidence of NEC. Administration of L. reuteri also improves the intestinal barrier both in human studies in children and in animal studies. Dietary supplements of L. reuteri to extremely premature infants may therefore improve feeding tolerance and nutrition and reduce the incidence of severe complications in this population.\n\nHYPOTHESIS Premature infants with extremely low birth weight receiving daily supplements of Lactobacillus reuteri DSM 17938 will reach full enteral feeding faster compared with children receiving placebo.\n\nSTUDY DESIGN This study will be conducted as a prospective multi-center double blind placebo-controlled study in neonatal intensive care units in Sweden. In total 134 neonates with extremely low birth weight (\\<1000g) and gestational age \\<28+0 weeks will be randomized to receive either dietary supplements of Lactobacillus reuteri or placebo. Study product will be identical to the active and placebo group besides the addition of Lactobacillus reuteri (1.25 x 100 million bacteria=0.2 ml oil drops per day) in the active group. The supplementation will commence within 1-3 days after birth and will be given daily until gestational week 36+0. The infants will be followed until gestational week 36+0 and data on feeding tolerance, nutrition, growth, infections, NEC, bronchopulmonary dysplasia, death, and potential confounders will be entered in an individual study protocol. Stool, breast milk, and blood samples will be collected for analyses of possible underlying mechanisms.\n\nA 2-year follow up including examination by pediatrician, growth parameters, questionnaire and psychology testing (Bayley´s test) will be performed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '3 Days', 'minimumAge': '1 Day', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Birth weight \\< 1000 g\n* Gestational age: v23+0-V27 +6.\n* Age \\< 72 hours at inclusion.\n* Signed informed consent by parents.\n\nExclusion Criteria:\n\n* Fatal or complex congenital malformation at inclusion time.\n* Chromosomal defect at inclusion time.\n* No realistic hope of survival at inclusion time.\n* Gastrointestinal malformation at inclusion time.\n* Participation in another study which aims to influence nutrition, growth, feeding tolerance or necrotizing enterocolitis.'}, 'identificationModule': {'nctId': 'NCT01603368', 'acronym': 'PROPEL', 'briefTitle': 'Prophylactic Probiotics to Extremely Low Birth Weight Prematures', 'organization': {'class': 'OTHER', 'fullName': 'Ostergotland County Council, Sweden'}, 'officialTitle': 'Prophylactic Probiotics to Extremely Low Birth Weight Prematures', 'orgStudyIdInfo': {'id': 'Dnr 2012/28-31'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Lactobacillus reuteri', 'description': 'Lactobacillus reuteri DSM 17938, 125 million bacteria/day', 'interventionNames': ['Dietary Supplement: Lactobacillus reuteri']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'The same oil drops as the active study product but without Lactobacillus reuteri', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Lactobacillus reuteri', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oil drops with Lactobacillus reuteri DSM 17938, 125 million bacteria=0.2 ml per day', 'armGroupLabels': ['Lactobacillus reuteri']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Oil drops without Lactobacillus reuteri', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60379', 'city': 'Norrköping', 'country': 'Sweden', 'facility': 'Vrinnevi Hospital in Norrköping', 'geoPoint': {'lat': 58.59419, 'lon': 16.1826}}, {'zip': 'SE-171 76', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Karolinska', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Thomas Abrahamsson, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linköping University Hospital; County Council of Östergötland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ostergotland County Council, Sweden', 'class': 'OTHER'}, 'collaborators': [{'name': 'BioGaia AB', 'class': 'INDUSTRY'}, {'name': 'Ekhaga Foundation, Sweden', 'class': 'UNKNOWN'}, {'name': 'Medical Research Council of Southeast Sweden', 'class': 'OTHER_GOV'}, {'name': 'University Hospital, Linkoeping', 'class': 'OTHER'}, {'name': 'The Swedish Research Council', 'class': 'OTHER_GOV'}, {'name': 'The Swedish Society of Medicine', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Neonatologist', 'investigatorFullName': 'Thomas Abrahamsson, MD, PhD', 'investigatorAffiliation': 'Ostergotland County Council, Sweden'}}}}