Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2025-12-26 @ 1:08 AM
Study NCT ID:
NCT00308334
Status:
COMPLETED
Last Update Posted:
2009-06-11
First Post:
2006-03-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D047928', 'term': 'Premature Birth'}], 'ancestors': [{'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004294', 'term': 'Domperidone'}], 'ancestors': [{'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D001562', 'term': 'Benzimidazoles'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-06', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-06-10', 'studyFirstSubmitDate': '2006-03-27', 'studyFirstSubmitQcDate': '2006-03-27', 'lastUpdatePostDateStruct': {'date': '2009-06-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-03-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The protein levels from breast milk will be compared, between the two groups (taking into consideration the expected rate of decline associated with increasing postpartum days).', 'timeFrame': 'days 0, 4, 7, and 14'}], 'secondaryOutcomes': [{'measure': 'The fat, carbohydrate, lactose, energy, calcium, phosphorus and sodium content of breast milk will be compared between domperidone and placebo groups.', 'timeFrame': 'days 0, 4, 7, and 14,'}, {'measure': 'Breast milk volumes (if the infant breast feeds, volume will be estimated using pre and post feeding weights)', 'timeFrame': 'Daily X 14 days'}, {'measure': 'Serum prolactin level', 'timeFrame': 'Day 0, 4 and 14'}, {'measure': 'infant weights', 'timeFrame': 'daily X 14 days'}, {'measure': 'breastfeeding rates', 'timeFrame': 'two weeks after treatment completion and at discharge'}]}, 'conditionsModule': {'keywords': ['Domperidone', 'breast milk', 'breast milk composition', 'preterm infant', 'neonate', 'nutrition'], 'conditions': ['Low Breast Milk Supply']}, 'referencesModule': {'references': [{'pmid': '16719919', 'type': 'BACKGROUND', 'citation': 'Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Allen VM, Dooley KC. Study protocol: a double blind placebo controlled trial examining the effect of domperidone on the composition of breast milk [NCT00308334]. BMC Pregnancy Childbirth. 2006 May 23;6:17. doi: 10.1186/1471-2393-6-17.'}, {'pmid': '20008425', 'type': 'DERIVED', 'citation': 'Campbell-Yeo ML, Allen AC, Joseph KS, Ledwidge JM, Caddell K, Allen VM, Dooley KC. Effect of domperidone on the composition of preterm human breast milk. Pediatrics. 2010 Jan;125(1):e107-14. doi: 10.1542/peds.2008-3441. Epub 2009 Dec 14.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.', 'detailedDescription': 'Domperidone, a drug that enhances upper gastric motility, is an anti-dopaminergic medication that also elevates prolactin levels. It has been shown to safely increase the milk supply of lactating women. To date, researchers have analyzed the effects of domperidone on lactating woman with respect to the quantity of their milk production, adverse effects, and drug levels in the breast milk. However, the effect of domperidone on the macronutrient composition of breast milk has not been studied and current guidelines for fortification of human milk for premature infants do not distinguish between those women using or those not using domperidone. The purpose of this study is to evaluate the effect of domperidone (given to lactating mothers of very preterm infants) on the macronutrient composition of human milk.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* i. Mother of an infant born less than 31 weeks gestation\n* ii. Women mechanically expressing breast milk using a double collecting system\n* iii. Experiencing lactation failure indicated by at least one of the following: A decreasing milk supply (by greater than 30 percent from peak volume based on maternal account) An inability to provide adequate breast milk to meet the daily nutritional intake of their infant\n* iv. Women who have had little or no improvement in milk production following education/counseling with a lactation consultant/Neonatal Intensive Care nurse with respect to non-pharmacological techniques.\n* v. Postpartum period equal to or greater than three weeks.\n\nExclusion Criteria:\n\n* i. Participants receiving any medication known to alter the effect of domperidone (e.g.cimetidine, ranitidine, famotidine, and nizatidine) or medication that interacts with domperidone (e.g. haloperidol, lithium).\n* ii. Experiencing mastitis\n* iii. Having a chronic or debilitating illness.\n* iv. Previous breast surgery\n* v. Having a known lactose intolerance'}, 'identificationModule': {'nctId': 'NCT00308334', 'briefTitle': "Effect of Domperidone on the Nutrient Composition of Preterm Mother's Breast Milk", 'organization': {'class': 'OTHER', 'fullName': 'IWK Health Centre'}, 'officialTitle': 'A Double Blind Placebo Controlled Trial Examining the Effect of Domperidone on the Composition of Breast Milk', 'orgStudyIdInfo': {'id': '2498'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Domperidone', 'description': 'Domperidone', 'interventionNames': ['Drug: Domperidone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placeob- Sugar pill', 'interventionNames': ['Drug: Placebo- Sugar pill']}], 'interventions': [{'name': 'Domperidone', 'type': 'DRUG', 'description': '10 mg po TID X 14 days', 'armGroupLabels': ['Domperidone']}, {'name': 'Placebo- Sugar pill', 'type': 'DRUG', 'description': 'placebo po TID x 14 days', 'armGroupLabels': ['placeob- Sugar pill']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'B3K 6R8', 'city': 'Halifax', 'state': 'Nova Scotia', 'country': 'Canada', 'facility': 'IWK Health Centre', 'geoPoint': {'lat': 44.64269, 'lon': -63.57688}}], 'overallOfficials': [{'name': 'Marsha L Campbell-Yeo, MN NNP-BC PhDc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'IWK Health Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'IWK Health Centre', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Nurses Foundation (CNF)', 'class': 'OTHER'}, {'name': 'Dalhousie University', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Marsha Campbell-Yeo', 'oldOrganization': 'IWK Health Centre'}}}}