Ignite Creation Date:
2025-12-24 @ 2:04 PM
Ignite Modification Date:
2026-02-27 @ 10:37 AM
Study NCT ID:
NCT02128295
Status:
UNKNOWN
Last Update Posted:
2015-12-03
First Post:
2014-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Two Electric Breast Pumps in Mothers of Term Infants.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D061186', 'term': 'Breast Milk Expression'}], 'ancestors': [{'id': 'D001942', 'term': 'Breast Feeding'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 228}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-02', 'studyFirstSubmitDate': '2014-04-29', 'studyFirstSubmitQcDate': '2014-04-30', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The total weight of milk expressed in a set 20 minute period (10 minutes / breast)', 'timeFrame': 'up to 20 minutes', 'description': 'The weight of milk expressed will be measured every minute for 20 minutes (10 mins/side) when the infants are around 5-6 weeks old.'}], 'secondaryOutcomes': [{'measure': 'Exclusive and partial breast-feeding', 'timeFrame': 'up to 6 months', 'description': 'Data will be collected at the end of each month when infants are 3 to 6 months of age to record if the infants are still being exclusively or partially breast-fed.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Breast pumps, breast milk, expression, term infants'], 'conditions': ['Volume of Breast Milk Expressed Using Single Electric Breast Pumps.', 'Duration of Exclusive Breast-feeding', 'Duration of Any Breast-feeding']}, 'descriptionModule': {'briefSummary': "This is a randomised trial of two modern single electric breast pumps allocated to mothers who are exclusively breast feeding their healthy term infants. Mothers will be recruited when their infants are around a month old, they will be randomised either to use one of two state of the art modern single electric breast pumps or to act as controls with no breast pump (but will receive a baby care voucher of similar value). If allocated to a breast pump, mothers will be asked to take part in a physiological study when their babies are 6 weeks old. In this test the mothers will be asked to express breast milk for 10 minutes on each breast. The primary hypothesis is that the total weight of milk produced in a 20 minute period and the weight of milk produced at 1 minute intervals at age 6 weeks will be greater for mothers using one of the pumps. A small sample of breast milk (\\~5ml) will be collected for analysis, the remaining expressed milk will returned to the mother.\n\nEach month between the age of 3 and 6 months, all the mothers will be asked to complete online questionnaires about their breast-feeding and the use of their breast pumps (if they have one). At the end of the six months the mothers will be given a small voucher for a child-care store as a way of saying 'thank-you' for the inconvenience caused."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMothers who have delivered healthy, term, singleton infants with no contra-indications for successful breast feeding.\n\nMothers who are exclusively breast feeding and are willing to be randomised to either use a breast pump or to continue breastfeeding without using a breast pump.\n\nNot already using a breast pump. Can speak, read and write in English (or Chinese for Beijing centre or Russian for Moscow centre)\n\nExclusion Criteria:\n\nMothers are ineligible to join the study:\n\nIf they are mixed or formula feeding. Have an illness that may prevent them from expressing breast milk. Are not willing to be randomly assigned to the pump or the control group Already expressing milk regularly.\n\n\\-'}, 'identificationModule': {'nctId': 'NCT02128295', 'briefTitle': 'Trial of Two Electric Breast Pumps in Mothers of Term Infants.', 'organization': {'class': 'OTHER', 'fullName': 'University College, London'}, 'officialTitle': 'Randomised Trial Comparing the Efficacy and Acceptability of Two Single Electric Breast Pump in Mothers Exclusively Breast Feeding Their Healthy Term Infants.', 'orgStudyIdInfo': {'id': '12NT04'}, 'secondaryIdInfos': [{'id': 'UCL Ethics project ID 5645/001', 'type': 'OTHER', 'domain': 'UCL Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Primiparous mothers', 'description': 'Mother who are primiparous', 'interventionNames': ['Device: Electric breast pump - A', 'Device: Electric breast pump - B']}, {'type': 'EXPERIMENTAL', 'label': 'Multiparous mothers', 'description': 'Mothers who are multiparous', 'interventionNames': ['Device: Electric breast pump - A', 'Device: Electric breast pump - B']}], 'interventions': [{'name': 'Electric breast pump - A', 'type': 'DEVICE', 'otherNames': ['Philips Avent single electric breast pump'], 'armGroupLabels': ['Multiparous mothers', 'Primiparous mothers']}, {'name': 'Electric breast pump - B', 'type': 'DEVICE', 'otherNames': ['Medela Swing single electric breast pump'], 'armGroupLabels': ['Multiparous mothers', 'Primiparous mothers']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'WC1N 1EH', 'city': 'London', 'state': 'London', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Katherine Kennedy, MSc', 'role': 'CONTACT', 'email': 'k.kennedy@ucl.ac.uk', 'phone': '0044 20905 2256'}], 'facility': 'Nutrition Unit, ICH-UCL', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}], 'centralContacts': [{'name': 'Mary Fewtrell', 'role': 'CONTACT', 'email': 'm.fewtrell@ucl.ac.uk', 'phone': '020 7905 2389'}, {'name': 'Kathy Kennedy', 'role': 'CONTACT', 'email': 'k.kennedy@ucl.ac.uk', 'phone': '020 7905 2256'}], 'overallOfficials': [{'name': 'Mary S Fewtrell, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Institute of Child Health, UCL London'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University College, London', 'class': 'OTHER'}, 'collaborators': [{'name': 'Northwell Health', 'class': 'OTHER'}, {'name': 'Scientific Center of Children', 'class': 'UNKNOWN'}, {'name': 'Capital Medical University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}