{ "FullStudy":{ "Rank":217875, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01515696", "OrgStudyIdInfo":{ "OrgStudyId":"27112001" }, "SecondaryIdInfoList":{ "SecondaryIdInfo":[ { "SecondaryId":"2007-000851-33", "SecondaryIdType":"EudraCT Number" } ] }, "Organization":{ "OrgFullName":"Medical University of Vienna", "OrgClass":"OTHER" }, "BriefTitle":"Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants", "OfficialTitle":"Impact of Oral Application of Gastrografin on the Meconium Evacuation in Very Low Birth Weight Infants- a Phase 4 Study" }, "StatusModule":{ "StatusVerifiedDate":"June 2014", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"October 2007" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2010", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"February 2011", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 23, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 24, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"October 29, 2013", "ResultsFirstSubmitQCDate":"June 17, 2014", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"July 18, 2014", "ResultsFirstPostDateType":"Estimate" }, "LastUpdateSubmitDate":"June 17, 2014", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"July 18, 2014", "LastUpdatePostDateType":"Estimate" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor-Investigator", "ResponsiblePartyInvestigatorFullName":"Nadja Haiden,MD", "ResponsiblePartyInvestigatorTitle":"Assoc.Prof.MD.", "ResponsiblePartyInvestigatorAffiliation":"Medical University of Vienna" }, "LeadSponsor":{ "LeadSponsorName":"Nadja Haiden,MD", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"Gastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a strong osmotic effect and leads to water influx into the intestine lumen. Thereby the peristaltic movement is accelerated and the premature infant excretes stool during the hours following application. Therefore Gastrografin might be effective to mobilize meconium from small bowel and deep parts of the colon. The investigators hypothesized that enteral application of Gastrografin accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population.", "DetailedDescription":"In premature infants the establishment of proper gastrointestinal function is challenging and often associated with delayed meconium passage. Meconium evacuation depends on gestational age and birthweight: the more immature an infant is, the later meconium passage starts and the longer meconium passage lasts. The mean duration of meconium evacuation in premature infants with a gestational age below 30 weeks is 8 days, while mature infants excrete their meconium in 2 days. The obstruction of deep intestinal segments by tenacious, sticky meconium frequently leads to gastric residuals, a distended abdomen and delayed food passage. The time lag to full enteral feedings is extended, the probability to acquire infections due to intravenous access for parenteral nutrition increases and the hospital stay of the infant is prolonged. However, the relation between meconium passage and feeding tolerance remains controversial. While one study showed that there is little concordance between first meconium passage and feeding tolerance, an other one showed that rapid and complete excretion of meconium is crucial for oral feeding tolerance and has a positive effect on it. Recently, the investigators performed a prospective randomized trial to determine, whether repeated prophylactic applications of small volume glycerin enemas accelerate passage of meconium in very low birth weight (VLBW) infants. Disappointingly, application of enemas did not accelerate meconium evacuation. A possible reason for the ineffectiveness of glycerin enemas is that the volume used was too small to mobilize tenacious meconium sufficiently from the colon and small bowel.\n\nGastrografin is a radiopaque contrast agent for the gastrointestinal tract (GIT) which can be applied orally or rectally. In neonatal intensive care, Gastrografin is used to detect otherwise radiologically invisible perforations or an insufficient GIT anastomosis after surgery. Furthermore it is used for the treatment of meconium ileus. Gastrografin has a strong osmotic effect and leads to water influx into the intestine lumen. Thereby the peristaltic movement is accelerated and the premature infant excretes stool during the hours following application. Therefore Gastrografin might be more effective to mobilize meconium from small bowel and deep parts of the colon. The investigators hypothesized, that enteral application of Gastrografin accelerates meconium evacuation in premature infants, and thereby enhances feeding tolerance in this population. The objective of the present study is to determine whether the enteral application of the osmotic contrast agent Gastrografin® accelerates complete meconium excretion and improves feeding tolerance in very low birth weight infants." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Meconium Ileus", "Very Low Birth Weight Infant" ] }, "KeywordList":{ "Keyword":[ "VLBW infant", "Meconium", "Enteral nutrition", "Meconium passage" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 4" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Triple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"96", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Gastrografin", "ArmGroupType":"Active Comparator", "ArmGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Gastrografin" ] } },{ "ArmGroupLabel":"Sterile water", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"infants receive 9ml/kg sterile water", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Sterile water" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Gastrografin", "InterventionDescription":"Patients will receive 3ml Gastrografin + 6ml sterile water/kg as a single dose via a nasogastric tube during the first 24 hours of life.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Gastrografin" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Diatrizoate Meglumine, Diatrizoate Sodium", "NDA-011245" ] } },{ "InterventionType":"Drug", "InterventionName":"Sterile water", "InterventionDescription":"Patients will receive 9ml/kg sterile water as a single dose via a nasogastric tube during the first 24 hours of life.", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Sterile water" ] }, "InterventionOtherNameList":{ "InterventionOtherName":[ "Sterile water (ANDA) #077393" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Time to Complete Meconium Evacuation in Days", "PrimaryOutcomeDescription":"Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life", "PrimaryOutcomeTimeFrame":"days of life until until the complete meconium evacuation from birth up to 40 days of life" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Feeding Tolerance- Full Enteral Feedings", "SecondaryOutcomeDescription":"full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg", "SecondaryOutcomeTimeFrame":"days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\npremature infants with a birthweight < 1500g and a gestational age < 32 weeks\n\nExclusion Criteria:\n\nmajor congenital disorders\nchromosomal aberrations\nsystemic metabolic disease and\npre-existing gastrointestinal abnormalities (i.e. Morbus Hirschsprung)\npre-existing conditions of severe hypotension", "HealthyVolunteers":"No", "Gender":"All", "MaximumAge":"24 Hours", "StdAgeList":{ "StdAge":[ "Child" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Nadja Haiden, MD", "OverallOfficialAffiliation":"Medical university of Vienna, Department of Pediatrics", "OverallOfficialRole":"Principal Investigator" } ] } } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Six hundred ninety-three infants were excluded for the following reasons: informed consent was not obtained in time(n = 660), parental refusal (n = 21), and 12 infants died before randomization.", "FlowRecruitmentDetails":"3 year study period 789 infants were eligible for enrollment in the study", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Gastrografin", "FlowGroupDescription":"infants received 3ml/kg Gastrografin + 6ml/kg sterile water once during the first 24 hours of life via gastric tube" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Sterile Water", "FlowGroupDescription":"infants received 9ml/kg sterile water once during the first 24 hours of life via gastric tube" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"47" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"49" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"39" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"39" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"8" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"10" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Gastrografin", "BaselineGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Sterile Water", "BaselineGroupDescription":"infants receive 9ml/kg sterile water" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"47" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"49" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"96" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Categorical", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"<=18 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"49" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"96" } ] } },{ "BaselineCategoryTitle":"Between 18 and 65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } },{ "BaselineCategoryTitle":">=65 years", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"27" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"47" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"20" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"49" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Region of Enrollment", "BaselineMeasureParamType":"Number", "BaselineMeasureUnitOfMeasure":"participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineClassTitle":"Austria", "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"47" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"49" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"96" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"birthweight", "BaselineMeasureParamType":"Median", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"grams", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"870", "BaselineMeasurementSpread":"0", "BaselineMeasurementLowerLimit":"490", "BaselineMeasurementUpperLimit":"1440" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"900", "BaselineMeasurementSpread":"0", "BaselineMeasurementLowerLimit":"480", "BaselineMeasurementUpperLimit":"1414" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"879", "BaselineMeasurementSpread":"0", "BaselineMeasurementLowerLimit":"480", "BaselineMeasurementUpperLimit":"1440" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Time to Complete Meconium Evacuation in Days", "OutcomeMeasureDescription":"Time to complete meconium evacuation in days of life until the complete meconium evacuation from birth up to 40 days of life", "OutcomeMeasurePopulationDescription":"per protocol", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"days of life", "OutcomeMeasureTimeFrame":"days of life until until the complete meconium evacuation from birth up to 40 days of life", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Gastrografin", "OutcomeGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Sterile Water", "OutcomeGroupDescription":"infants receive 9ml/kg sterile water" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"39" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"39" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"7", "OutcomeMeasurementLowerLimit":"3", "OutcomeMeasurementUpperLimit":"16" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"8", "OutcomeMeasurementLowerLimit":"1", "OutcomeMeasurementUpperLimit":"24" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.61", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisParamType":"Median Difference (Net)", "OutcomeAnalysisParamValue":"1", "OutcomeAnalysisCIPctValue":"95" } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Feeding Tolerance- Full Enteral Feedings", "OutcomeMeasureDescription":"full enteral feeding is defined in days of life from birth until an an infant tolerates an enteral feeding volume of 140ml/kg", "OutcomeMeasurePopulationDescription":"per protocol", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Median", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"days", "OutcomeMeasureTimeFrame":"days of life from birth until an infant tolerates en enteral feeding volume of 140 ml/kg", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Gastrografin", "OutcomeGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Sterile Water", "OutcomeGroupDescription":"infants receive 9ml/kg sterile water" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"39" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"39" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"19", "OutcomeMeasurementLowerLimit":"10", "OutcomeMeasurementUpperLimit":"68" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26.5", "OutcomeMeasurementLowerLimit":"9", "OutcomeMeasurementUpperLimit":"109" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":"0.05", "OutcomeAnalysisStatisticalMethod":"Wilcoxon (Mann-Whitney)", "OutcomeAnalysisParamType":"Median Difference (Final Values)", "OutcomeAnalysisParamValue":"7.5", "OutcomeAnalysisCIPctValue":"95" } ] } },{ "OutcomeMeasureType":"Post-Hoc", "OutcomeMeasureTitle":"Necrotizing Enterocolitis", "OutcomeMeasureDescription":"necrotizing enterocolitis stage 2a after Bell", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Number", "OutcomeMeasureUnitOfMeasure":"participants", "OutcomeMeasureTimeFrame":"End of study", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Gastrografin", "OutcomeGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Sterile Water", "OutcomeGroupDescription":"infants receive 9ml/kg sterile water" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"39" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"39" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"8" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"3" } ] } } ] } } ] }, "OutcomeAnalysisList":{ "OutcomeAnalysis":[ { "OutcomeAnalysisGroupIdList":{ "OutcomeAnalysisGroupId":[ "OG000", "OG001" ] }, "OutcomeAnalysisTestedNonInferiority":"No", "OutcomeAnalysisNonInferiorityType":"Superiority or Other", "OutcomeAnalysisPValue":">0.05", "OutcomeAnalysisStatisticalMethod":"Chi-squared" } ] } } ] } }, "AdverseEventsModule":{ "EventsFrequencyThreshold":"0", "EventsTimeFrame":"from birth until discharge of the infant with a maximum of 5 months", "EventGroupList":{ "EventGroup":[ { "EventGroupId":"EG000", "EventGroupTitle":"Gastrografin", "EventGroupDescription":"infants receive 3ml/kg Gastrografin + 6ml/kg sterile water", "EventGroupSeriousNumAffected":"43", "EventGroupSeriousNumAtRisk":"47", "EventGroupOtherNumAffected":"5", "EventGroupOtherNumAtRisk":"47" },{ "EventGroupId":"EG001", "EventGroupTitle":"Sterile Water", "EventGroupDescription":"infants receive 9ml/kg sterile water", "EventGroupSeriousNumAffected":"42", "EventGroupSeriousNumAtRisk":"49", "EventGroupOtherNumAffected":"6", "EventGroupOtherNumAtRisk":"49" } ] }, "SeriousEventList":{ "SeriousEvent":[ { "SeriousEventTerm":"intraventricular haemorrhage", "SeriousEventOrganSystem":"Nervous system disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"intraventricular haemorrhage grade 3 and 4 according the definition of papillae et al", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"47" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"3", "SeriousEventStatsNumAffected":"3", "SeriousEventStatsNumAtRisk":"49" } ] } },{ "SeriousEventTerm":"necrotizing enterocolitis", "SeriousEventOrganSystem":"Gastrointestinal disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"necrotizing enterocolitis stage II or more according to Bell", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"10", "SeriousEventStatsNumAffected":"10", "SeriousEventStatsNumAtRisk":"47" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"4", "SeriousEventStatsNumAffected":"4", "SeriousEventStatsNumAtRisk":"49" } ] } },{ "SeriousEventTerm":"persistent ductus arteriosus", "SeriousEventOrganSystem":"Cardiac disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"22", "SeriousEventStatsNumAffected":"22", "SeriousEventStatsNumAtRisk":"47" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"28", "SeriousEventStatsNumAffected":"28", "SeriousEventStatsNumAtRisk":"49" } ] } },{ "SeriousEventTerm":"death", "SeriousEventOrganSystem":"Congenital, familial and genetic disorders", "SeriousEventAssessmentType":"Non-systematic Assessment", "SeriousEventNotes":"death because of immaturity and associated complications like multiple organ failure", "SeriousEventStatsList":{ "SeriousEventStats":[ { "SeriousEventStatsGroupId":"EG000", "SeriousEventStatsNumEvents":"8", "SeriousEventStatsNumAffected":"8", "SeriousEventStatsNumAtRisk":"47" },{ "SeriousEventStatsGroupId":"EG001", "SeriousEventStatsNumEvents":"7", "SeriousEventStatsNumAffected":"7", "SeriousEventStatsNumAtRisk":"49" } ] } } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"culture proven sepsis", "OtherEventOrganSystem":"Infections and infestations", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"5", "OtherEventStatsNumAffected":"5", "OtherEventStatsNumAtRisk":"47" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"6", "OtherEventStatsNumAffected":"6", "OtherEventStatsNumAtRisk":"49" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"Yes", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Nadja Haiden M.D.", "PointOfContactOrganization":"Medical University of Vienna", "PointOfContactEMail":"nadja.haiden@meduniwien.ac.at", "PointOfContactPhone":"+431404003232" } } }, "DerivedSection":{ "MiscInfoModule":{ "VersionHolder":"April 22, 2020" }, "ConditionBrowseModule":{ "ConditionMeshList":{ "ConditionMesh":[ { "ConditionMeshId":"D000074270", "ConditionMeshTerm":"Meconium Ileus" },{ "ConditionMeshId":"D000001835", "ConditionMeshTerm":"Body Weight" },{ "ConditionMeshId":"D000001724", "ConditionMeshTerm":"Birth Weight" } ] }, "ConditionAncestorList":{ "ConditionAncestor":[ { "ConditionAncestorId":"D000012816", "ConditionAncestorTerm":"Signs and Symptoms" },{ "ConditionAncestorId":"D000007415", "ConditionAncestorTerm":"Intestinal Obstruction" },{ "ConditionAncestorId":"D000007410", "ConditionAncestorTerm":"Intestinal Diseases" },{ "ConditionAncestorId":"D000005767", "ConditionAncestorTerm":"Gastrointestinal Diseases" },{ "ConditionAncestorId":"D000004066", "ConditionAncestorTerm":"Digestive System Diseases" } ] }, "ConditionBrowseLeafList":{ "ConditionBrowseLeaf":[ { "ConditionBrowseLeafId":"M3696", "ConditionBrowseLeafName":"Body Weight", "ConditionBrowseLeafAsFound":"Weight", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M3588", "ConditionBrowseLeafName":"Birth Weight", "ConditionBrowseLeafAsFound":"Birth Weight", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M24172", "ConditionBrowseLeafName":"Ileus", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M1336", "ConditionBrowseLeafName":"Meconium Ileus", "ConditionBrowseLeafAsFound":"Meconium Ileus", "ConditionBrowseLeafRelevance":"high" },{ "ConditionBrowseLeafId":"M9032", "ConditionBrowseLeafName":"Intestinal Obstruction", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M9027", "ConditionBrowseLeafName":"Intestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M7466", "ConditionBrowseLeafName":"Gastrointestinal Diseases", "ConditionBrowseLeafRelevance":"low" },{ "ConditionBrowseLeafId":"M5838", "ConditionBrowseLeafName":"Digestive System Diseases", "ConditionBrowseLeafRelevance":"low" } ] }, "ConditionBrowseBranchList":{ "ConditionBrowseBranch":[ { "ConditionBrowseBranchAbbrev":"BC23", "ConditionBrowseBranchName":"Symptoms and General Pathology" },{ "ConditionBrowseBranchAbbrev":"All", "ConditionBrowseBranchName":"All Conditions" },{ "ConditionBrowseBranchAbbrev":"BC06", "ConditionBrowseBranchName":"Digestive System Diseases" } ] } } } } } }