{ "FullStudy":{ "Rank":218139, "Study":{ "ProtocolSection":{ "IdentificationModule":{ "NCTId":"NCT01512225", "OrgStudyIdInfo":{ "OrgStudyId":"232-2011" }, "Organization":{ "OrgFullName":"Sunnybrook Health Sciences Centre", "OrgClass":"OTHER" }, "BriefTitle":"Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates", "OfficialTitle":"Enhancing Breast Milk Production With Domperidone in Mothers of Preterm Neonates", "Acronym":"EMPOWER" }, "StatusModule":{ "StatusVerifiedDate":"March 2017", "OverallStatus":"Completed", "ExpandedAccessInfo":{ "HasExpandedAccess":"No" }, "StartDateStruct":{ "StartDate":"May 2012" }, "PrimaryCompletionDateStruct":{ "PrimaryCompletionDate":"October 2015", "PrimaryCompletionDateType":"Actual" }, "CompletionDateStruct":{ "CompletionDate":"March 2016", "CompletionDateType":"Actual" }, "StudyFirstSubmitDate":"January 10, 2012", "StudyFirstSubmitQCDate":"January 13, 2012", "StudyFirstPostDateStruct":{ "StudyFirstPostDate":"January 19, 2012", "StudyFirstPostDateType":"Estimate" }, "ResultsFirstSubmitDate":"November 7, 2016", "ResultsFirstSubmitQCDate":"March 8, 2017", "ResultsFirstPostDateStruct":{ "ResultsFirstPostDate":"April 20, 2017", "ResultsFirstPostDateType":"Actual" }, "LastUpdateSubmitDate":"March 8, 2017", "LastUpdatePostDateStruct":{ "LastUpdatePostDate":"April 20, 2017", "LastUpdatePostDateType":"Actual" } }, "SponsorCollaboratorsModule":{ "ResponsibleParty":{ "ResponsiblePartyType":"Sponsor" }, "LeadSponsor":{ "LeadSponsorName":"Sunnybrook Health Sciences Centre", "LeadSponsorClass":"OTHER" } }, "OversightModule":{ "OversightHasDMC":"Yes" }, "DescriptionModule":{ "BriefSummary":"The purpose of this study is to evaluate the safety and efficacy of Domperidone in those mothers who are identified as having difficulty with breast milk production to meet the nutritional needs of their infant in the neonatal intensive are unit hospitalization setting, and to determine how it should be considered in the care of mothers and their preterm infants without causing undesirable effects to either the mother or infant.", "DetailedDescription":"It is widely acknowledged that recent perinatal and neonatal technological advances (eg. assisted ventilation, surfactant, antenatal corticosteroids) have greatly enhanced the survival rate of very low birth weight and extremely low birth weight infants. A compelling body of evidence now exists to suggest that use of breast milk to feed preterm infants during initial hospitalization positively impacts their neurodevelopment during early childhood and beyond. In order to provide breastmilk, mothers of preterm infants have to begin to produce and mechanically express milk. However, these mothers are often faced with challenges in maintaining an adequate volume that will meet their infants' nutritional needs, as well as declines in production after several weeks despite a myriad of measures designed to assist in production. The primary hypothesis for this study is that Domperidone, through its pharmacologic action on increasing prolactin levels, will assist mothers experiencing inadequate breast milk production in increasing breast milk volumes to a level identified as being sufficient for continued pumping in the hospitalization period." }, "ConditionsModule":{ "ConditionList":{ "Condition":[ "Low Milk Supply" ] }, "KeywordList":{ "Keyword":[ "breastmilk", "domperidone", "preterm" ] } }, "DesignModule":{ "StudyType":"Interventional", "PhaseList":{ "Phase":[ "Phase 2" ] }, "DesignInfo":{ "DesignAllocation":"Randomized", "DesignInterventionModel":"Parallel Assignment", "DesignPrimaryPurpose":"Treatment", "DesignMaskingInfo":{ "DesignMasking":"Quadruple", "DesignWhoMaskedList":{ "DesignWhoMasked":[ "Participant", "Care Provider", "Investigator", "Outcomes Assessor" ] } } }, "EnrollmentInfo":{ "EnrollmentCount":"90", "EnrollmentType":"Actual" } }, "ArmsInterventionsModule":{ "ArmGroupList":{ "ArmGroup":[ { "ArmGroupLabel":"Domperidone for days 1 to 28", "ArmGroupType":"Experimental", "ArmGroupDescription":"Domperidone maleate tablets 10 mg orally three times daily from days 1 to 28", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Domperidone maleate" ] } },{ "ArmGroupLabel":"Placebo for days 1 to 14 and domperidone for day 15-28", "ArmGroupType":"Placebo Comparator", "ArmGroupDescription":"Identical placebo tablets 10 mg orally three times daily from days 1 to 14 followed by Domperidone maleate tablets 10 mg orally three times daily from days 15 to 28", "ArmGroupInterventionList":{ "ArmGroupInterventionName":[ "Drug: Placebo Tablet", "Drug: Domperidone maleate" ] } } ] }, "InterventionList":{ "Intervention":[ { "InterventionType":"Drug", "InterventionName":"Domperidone maleate", "InterventionDescription":"domperidone maleate tablet 10 mg orally three times daily for 28 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Domperidone for days 1 to 28" ] } },{ "InterventionType":"Drug", "InterventionName":"Placebo Tablet", "InterventionDescription":"placebo tablet 10 mg orally three times daily for 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo for days 1 to 14 and domperidone for day 15-28" ] } },{ "InterventionType":"Drug", "InterventionName":"Domperidone maleate", "InterventionDescription":"domperidone maleate tablet 10 mg orally three times daily for 14 days", "InterventionArmGroupLabelList":{ "InterventionArmGroupLabel":[ "Placebo for days 1 to 14 and domperidone for day 15-28" ] } } ] } }, "OutcomesModule":{ "PrimaryOutcomeList":{ "PrimaryOutcome":[ { "PrimaryOutcomeMeasure":"Increase in Breast Milk Production", "PrimaryOutcomeDescription":"The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).", "PrimaryOutcomeTimeFrame":"Day 0 to day 14" } ] }, "SecondaryOutcomeList":{ "SecondaryOutcome":[ { "SecondaryOutcomeMeasure":"Increase in Breast Milk Volume on Day 28", "SecondaryOutcomeDescription":"Number of mothers who achieved 50% increase in milk volume on day 28", "SecondaryOutcomeTimeFrame":"day 0 to day 28" },{ "SecondaryOutcomeMeasure":"Mean Breast Milk Volumes on Day 14", "SecondaryOutcomeDescription":"Mean milk volumes between the two groups at 14 days of study intervention", "SecondaryOutcomeTimeFrame":"Day 0 and day 14" },{ "SecondaryOutcomeMeasure":"Mean Breast Milk Volumes on Day 28", "SecondaryOutcomeDescription":"Mean milk volumes between the two groups at 28 days of study intervention", "SecondaryOutcomeTimeFrame":"day 0 and 28" },{ "SecondaryOutcomeMeasure":"Mean Volume Change From Day 0 to Day 14", "SecondaryOutcomeDescription":"change on the volume of milk from day 0 to day 14 between the two groups", "SecondaryOutcomeTimeFrame":"days 0 and 14" },{ "SecondaryOutcomeMeasure":"Mean Volume Change on the Volume of Milk From Day 15 to Day 28", "SecondaryOutcomeDescription":"change on the volume of milk from day 15 to day 28 between the two groups", "SecondaryOutcomeTimeFrame":"day 15 and day 28" },{ "SecondaryOutcomeMeasure":"Provision of Breast Milk at Term Gestation", "SecondaryOutcomeDescription":"provision of breast milk as the primary source of nutrition", "SecondaryOutcomeTimeFrame":"term gestation" },{ "SecondaryOutcomeMeasure":"Provision of Breast Milk at 6 Weeks Post Term Gestation", "SecondaryOutcomeDescription":"Provision of breast milk at 6 weeks post term gestation as primary source of nutrition", "SecondaryOutcomeTimeFrame":"6 weeks post term gestation" } ] } }, "EligibilityModule":{ "EligibilityCriteria":"Inclusion Criteria:\n\nmothers of a preterm infant born < 30 completed weeks gestation (23 0/7-29 6/7 weeks)\npostpartum period of 7-21 days\nmechanically pumping a minimum average of 6 times a day in the 4-7 days prior to enrollment\nexperiencing inadequate milk supply defined as providing < 100% of the average of the daily nutritional intake during the previous 72-hour period prior to enrollment based on a fluid intake of 250 mL/kg/d or experiencing a clinical reduction of approximately 20% from a peak volume during the previous 72-hour period prior to enrollment\n\nExclusion Criteria:\n\nhistory of known or suspected cardiac dysrhythmias (tachyarrhythmia, Q-Tc prolongation) or currently on an anti-arrhythmic medication\ncurrently experiencing mastitis\nprevious breast surgery, including augmentation or reduction, nipple piercing and/or the use of nipple rings/studs within the last year, or any reduction\nknown chronic or debilitating illness, known abnormal liver function or gastric abnormalities gastrointestinal that will be exacerbated by the use of a prokinetic, examples include hemorrhage or blockage, actively treated with acid reflux which requires treatment for greater than 5 days and includes H2 blockers (occasional use of H2 blockers for heartburn or mild acid reflux is not considered an exclusion) and HIV\nknown to have a prolactin-releasing pituitary tumor\nreceiving medications known to alter the metabolism and pharmacokinetics of domperidone (eg. oral \"azole\" antifungals, erythromycin antibiotics, monoamine oxidase inhibitors (MAO) inhibitors) or medications that have dopaminergic or antidopaminergic activity or affect prolactin levels\nmothers of higher order pregnancies (triplet, or more)\ncurrently smoking 6 or more cigarette per day as reported by the mother", "HealthyVolunteers":"No", "Gender":"Female", "MinimumAge":"18 Years", "MaximumAge":"45 Years", "StdAgeList":{ "StdAge":[ "Adult" ] } }, "ContactsLocationsModule":{ "OverallOfficialList":{ "OverallOfficial":[ { "OverallOfficialName":"Elizabeth V Asztalos, MD", "OverallOfficialAffiliation":"Sunnybrook Research Institute", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Marsha Campbell-Yeo, PhD", "OverallOfficialAffiliation":"IWK Health Centre", "OverallOfficialRole":"Principal Investigator" },{ "OverallOfficialName":"Orlando Da Silva, MD", "OverallOfficialAffiliation":"Children's Hospital London Health Sciences Centre", "OverallOfficialRole":"Principal Investigator" } ] }, "LocationList":{ "Location":[ { "LocationFacility":"Sunnybrook Health Sciences Centre", "LocationCity":"Toronto", "LocationState":"Ontario", "LocationZip":"M4N 3M5", "LocationCountry":"Canada" } ] } }, "ReferencesModule":{ "ReferenceList":{ "Reference":[ { "ReferencePMID":"28107101", "ReferenceType":"result", "ReferenceCitation":"Asztalos EV, Campbell-Yeo M, da Silva OP, Ito S, Kiss A, Knoppert D; EMPOWER Study Collaborative Group. Enhancing Human Milk Production With Domperidone in Mothers of Preterm Infants. J Hum Lact. 2017 Feb;33(1):181-187. doi: 10.1177/0890334416680176. Epub 2017 Jan 20." },{ "ReferencePMID":"31171928", "ReferenceType":"derived", "ReferenceCitation":"Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Role of days postdelivery on breast milk production: a secondary analysis from the EMPOWER trial. Int Breastfeed J. 2019 Jun 4;14:21. doi: 10.1186/s13006-019-0215-z. eCollection 2019." },{ "ReferencePMID":"30543461", "ReferenceType":"derived", "ReferenceCitation":"Asztalos EV, Kiss A, daSilva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Evaluating the Effect of a 14-Day Course of Domperidone on Breast Milk Production: A Per-Protocol Analysis from the EMPOWER Trial. Breastfeed Med. 2019 Mar;14(2):102-107. doi: 10.1089/bfm.2018.0175. Epub 2018 Dec 13." },{ "ReferencePMID":"30410781", "ReferenceType":"derived", "ReferenceCitation":"Asztalos EV, Kiss A, da Silva OP, Campbell-Yeo M, Ito S, Knoppert D; EMPOWER Study Collaborative Group. Pregnancy gestation at delivery and breast milk production: a secondary analysis from the EMPOWER trial. Matern Health Neonatol Perinatol. 2018 Nov 5;4:21. doi: 10.1186/s40748-018-0089-x. eCollection 2018." },{ "ReferencePMID":"22935052", "ReferenceType":"derived", "ReferenceCitation":"Asztalos EV, Campbell-Yeo M, daSilva OP, Kiss A, Knoppert DC, Ito S. Enhancing breast milk production with Domperidone in mothers of preterm neonates (EMPOWER trial). BMC Pregnancy Childbirth. 2012 Aug 31;12:87. doi: 10.1186/1471-2393-12-87." } ] } }, "IPDSharingStatementModule":{ "IPDSharing":"No" } }, "ResultsSection":{ "ParticipantFlowModule":{ "FlowPreAssignmentDetails":"Mothers could be identified in the NICU as early as day 4 until day 18 post-delivery. Additional counseling and support by the lactation consultant with respect to non-pharmacologic techniques were offered. If there was no response to the techniques, the mother was considered eligible for the trial.", "FlowRecruitmentDetails":"Recruitment took place from June 1, 2012 to June 30, 2015 in 8 Neonatal Intensive Care Units in Canada", "FlowGroupList":{ "FlowGroup":[ { "FlowGroupId":"FG000", "FlowGroupTitle":"Group A: Domperidone", "FlowGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "FlowGroupId":"FG001", "FlowGroupTitle":"Group B: Placebo + Domperidone", "FlowGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "FlowPeriodList":{ "FlowPeriod":[ { "FlowPeriodTitle":"Overall Study", "FlowMilestoneList":{ "FlowMilestone":[ { "FlowMilestoneType":"STARTED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"45" } ] } },{ "FlowMilestoneType":"Provided Day 14 Volume", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"40" } ] } },{ "FlowMilestoneType":"COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"45" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"45" } ] } },{ "FlowMilestoneType":"NOT COMPLETED", "FlowAchievementList":{ "FlowAchievement":[ { "FlowAchievementGroupId":"FG000", "FlowAchievementNumSubjects":"0" },{ "FlowAchievementGroupId":"FG001", "FlowAchievementNumSubjects":"0" } ] } } ] } } ] } }, "BaselineCharacteristicsModule":{ "BaselineGroupList":{ "BaselineGroup":[ { "BaselineGroupId":"BG000", "BaselineGroupTitle":"Group A: Domperidone", "BaselineGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "BaselineGroupId":"BG001", "BaselineGroupTitle":"Group B: Placebo + Domperidone", "BaselineGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" },{ "BaselineGroupId":"BG002", "BaselineGroupTitle":"Total", "BaselineGroupDescription":"Total of all reporting groups" } ] }, "BaselineDenomList":{ "BaselineDenom":[ { "BaselineDenomUnits":"Participants", "BaselineDenomCountList":{ "BaselineDenomCount":[ { "BaselineDenomCountGroupId":"BG000", "BaselineDenomCountValue":"45" },{ "BaselineDenomCountGroupId":"BG001", "BaselineDenomCountValue":"45" },{ "BaselineDenomCountGroupId":"BG002", "BaselineDenomCountValue":"90" } ] } } ] }, "BaselineMeasureList":{ "BaselineMeasure":[ { "BaselineMeasureTitle":"Age, Continuous", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Full Range", "BaselineMeasureUnitOfMeasure":"years", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"31.25", "BaselineMeasurementLowerLimit":"20.96", "BaselineMeasurementUpperLimit":"40.59" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"33.56", "BaselineMeasurementLowerLimit":"23.23", "BaselineMeasurementUpperLimit":"39.50" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"32.41", "BaselineMeasurementLowerLimit":"20.96", "BaselineMeasurementUpperLimit":"40.59" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Sex: Female, Male", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Female", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"45" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"90" } ] } },{ "BaselineCategoryTitle":"Male", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"0" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Race/Ethnicity, Customized", "BaselineMeasureDescription":"Ethnicity was self-declared", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Caucasian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"29" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"30" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"59" } ] } },{ "BaselineCategoryTitle":"Black", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"4" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"10" } ] } },{ "BaselineCategoryTitle":"Asian", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"8" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"16" } ] } },{ "BaselineCategoryTitle":"Aboriginal", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"0" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"1" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"1" } ] } },{ "BaselineCategoryTitle":"Other", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"2" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"4" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Parity", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"0", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"28" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"33" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"61" } ] } },{ "BaselineCategoryTitle":">/= 1", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"17" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"12" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"29" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Type of pregnancy", "BaselineMeasureParamType":"Count of Participants", "BaselineMeasureUnitOfMeasure":"Participants", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineCategoryTitle":"Singleton", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"38" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"39" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"77" } ] } },{ "BaselineCategoryTitle":"Twins", "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"7" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"6" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"13" } ] } } ] } } ] } },{ "BaselineMeasureTitle":"Mean milk Volume at entry", "BaselineMeasureParamType":"Mean", "BaselineMeasureDispersionType":"Standard Deviation", "BaselineMeasureUnitOfMeasure":"millilitres", "BaselineClassList":{ "BaselineClass":[ { "BaselineCategoryList":{ "BaselineCategory":[ { "BaselineMeasurementList":{ "BaselineMeasurement":[ { "BaselineMeasurementGroupId":"BG000", "BaselineMeasurementValue":"121", "BaselineMeasurementSpread":"96" },{ "BaselineMeasurementGroupId":"BG001", "BaselineMeasurementValue":"115", "BaselineMeasurementSpread":"95" },{ "BaselineMeasurementGroupId":"BG002", "BaselineMeasurementValue":"118", "BaselineMeasurementSpread":"96" } ] } } ] } } ] } } ] } }, "OutcomeMeasuresModule":{ "OutcomeMeasureList":{ "OutcomeMeasure":[ { "OutcomeMeasureType":"Primary", "OutcomeMeasureTitle":"Increase in Breast Milk Production", "OutcomeMeasureDescription":"The primary outcome is the difference in the proportion of women having a 50% increase in breast milk volume at the end of 14 days of treatment with domperidone compared to mothers receiving placebo (mean day 14 volume minus mean day 0 volume at entry).", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"Day 0 to day 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: Domperidone", "OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"35" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"26" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Increase in Breast Milk Volume on Day 28", "OutcomeMeasureDescription":"Number of mothers who achieved 50% increase in milk volume on day 28", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Count of Participants", "OutcomeMeasureUnitOfMeasure":"Participants", "OutcomeMeasureTimeFrame":"day 0 to day 28", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: Domperidone", "OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"31" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"28" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Breast Milk Volumes on Day 14", "OutcomeMeasureDescription":"Mean milk volumes between the two groups at 14 days of study intervention", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"millilitres", "OutcomeMeasureTimeFrame":"Day 0 and day 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: Domperidone", "OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"267", "OutcomeMeasurementSpread":"189" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"217", "OutcomeMeasurementSpread":"168" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Breast Milk Volumes on Day 28", "OutcomeMeasureDescription":"Mean milk volumes between the two groups at 28 days of study intervention", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Standard Deviation", "OutcomeMeasureUnitOfMeasure":"millilitres", "OutcomeMeasureTimeFrame":"day 0 and 28", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: Domperidone", "OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"290", "OutcomeMeasurementSpread":"211" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"302", "OutcomeMeasurementSpread":"230" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Volume Change From Day 0 to Day 14", "OutcomeMeasureDescription":"change on the volume of milk from day 0 to day 14 between the two groups", "OutcomeMeasureReportingStatus":"Posted", "OutcomeMeasureParamType":"Mean", "OutcomeMeasureDispersionType":"Full Range", "OutcomeMeasureUnitOfMeasure":"millilitres", "OutcomeMeasureTimeFrame":"days 0 and 14", "OutcomeGroupList":{ "OutcomeGroup":[ { "OutcomeGroupId":"OG000", "OutcomeGroupTitle":"Group A: Domperidone", "OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"254", "OutcomeMeasurementLowerLimit":"-100", "OutcomeMeasurementUpperLimit":"2129" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"175", "OutcomeMeasurementLowerLimit":"-100", "OutcomeMeasurementUpperLimit":"923" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Mean Volume Change on the 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orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { "OutcomeMeasurementGroupId":"OG000", "OutcomeMeasurementValue":"22", "OutcomeMeasurementLowerLimit":"-68", "OutcomeMeasurementUpperLimit":"200" },{ "OutcomeMeasurementGroupId":"OG001", "OutcomeMeasurementValue":"49", "OutcomeMeasurementLowerLimit":"-100", "OutcomeMeasurementUpperLimit":"254" } ] } } ] } } ] } },{ "OutcomeMeasureType":"Secondary", "OutcomeMeasureTitle":"Provision of Breast Milk at Term Gestation", "OutcomeMeasureDescription":"provision of breast milk as the primary source of nutrition", 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"OutcomeGroupDescription":"Domperidone 10 mg orally three times daily for 28 days\n\nDomperidone maleate: domperidone 10 mg orally three times daily for 28 days" },{ "OutcomeGroupId":"OG001", "OutcomeGroupTitle":"Group B: Placebo + Domperidone", "OutcomeGroupDescription":"Identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days\n\nDomperidone maleate plus placebo: identical placebo 10 mg orally three times daily for 14 days followed by domperidone 10 mg orally three times daily for 14 days" } ] }, "OutcomeDenomList":{ "OutcomeDenom":[ { "OutcomeDenomUnits":"Participants", "OutcomeDenomCountList":{ "OutcomeDenomCount":[ { "OutcomeDenomCountGroupId":"OG000", "OutcomeDenomCountValue":"45" },{ "OutcomeDenomCountGroupId":"OG001", "OutcomeDenomCountValue":"45" } ] } } ] }, "OutcomeClassList":{ "OutcomeClass":[ { "OutcomeCategoryList":{ "OutcomeCategory":[ { "OutcomeMeasurementList":{ "OutcomeMeasurement":[ { 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times daily for 14 days", "EventGroupSeriousNumAffected":"0", "EventGroupSeriousNumAtRisk":"45", "EventGroupOtherNumAffected":"3", "EventGroupOtherNumAtRisk":"45" } ] }, "OtherEventList":{ "OtherEvent":[ { "OtherEventTerm":"Headache", "OtherEventOrganSystem":"Nervous system disorders", "OtherEventSourceVocabulary":"MedRa", "OtherEventAssessmentType":"Non-systematic Assessment", "OtherEventStatsList":{ "OtherEventStats":[ { "OtherEventStatsGroupId":"EG000", "OtherEventStatsNumEvents":"31", "OtherEventStatsNumAffected":"10", "OtherEventStatsNumAtRisk":"45" },{ "OtherEventStatsGroupId":"EG001", "OtherEventStatsNumEvents":"23", "OtherEventStatsNumAffected":"3", "OtherEventStatsNumAtRisk":"45" } ] } } ] } }, "MoreInfoModule":{ "CertainAgreement":{ "AgreementPISponsorEmployee":"No", "AgreementRestrictiveAgreement":"No" }, "PointOfContact":{ "PointOfContactTitle":"Dr. Elizabeth Asztalos", "PointOfContactOrganization":"Sunnybrook Research Institute", 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