Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-06 @ 1:33 PM
Study NCT ID:
NCT05465460
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-07-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2022-07-07', 'studyFirstSubmitQcDate': '2022-07-17', 'lastUpdatePostDateStruct': {'date': '2024-02-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Breast milk volume per day at day 14', 'timeFrame': 'at day 14', 'description': 'Breast milk volume measurement in milliliters'}, {'measure': 'Breast milk volume per day at day 3', 'timeFrame': 'at day 3', 'description': 'Breast milk volume measurement in milliliters'}, {'measure': 'Breast milk volume per day at day 7', 'timeFrame': 'at day 7', 'description': 'Breast milk volume measurement in milliliters'}], 'secondaryOutcomes': [{'measure': 'percentage of good satisfaction', 'timeFrame': 'at 14 days', 'description': 'satisfaction evaluated by 5 Likert scales'}, {'measure': 'percentage of side effects during intervention', 'timeFrame': 'day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14', 'description': 'percentage of participants with side effects such as headache, nausea/vomiting assessing by asking'}, {'measure': 'percentage of drug compliance', 'timeFrame': 'at 14 days', 'description': 'percentage of complete drug use assessing by remained drug counting'}, {'measure': 'factors associated with increasing breast milk volume', 'timeFrame': 'at 14 days', 'description': 'factors associated with increasing breast milk volume assessing by univariate and multivariate analysis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Preterm Birth', 'Postpartum Women']}, 'referencesModule': {'references': [{'pmid': '15681632', 'type': 'BACKGROUND', 'citation': 'Hill PD, Aldag JC, Chatterton RT, Zinaman M. Comparison of milk output between mothers of preterm and term infants: the first 6 weeks after birth. J Hum Lact. 2005 Feb;21(1):22-30. doi: 10.1177/0890334404272407.'}, {'pmid': '30776448', 'type': 'BACKGROUND', 'citation': 'Yu X, Li J, Lin X, Luan D. Association between Delayed Lactogenesis Ⅱ and Early Milk Volume among Mothers of Preterm Infants. Asian Nurs Res (Korean Soc Nurs Sci). 2019 May;13(2):93-98. doi: 10.1016/j.anr.2019.02.001. Epub 2019 Feb 16.'}, {'pmid': '15687416', 'type': 'BACKGROUND', 'citation': 'Ronnestad A, Abrahamsen TG, Medbo S, Reigstad H, Lossius K, Kaaresen PI, Egeland T, Engelund IE, Irgens LM, Markestad T. Late-onset septicemia in a Norwegian national cohort of extremely premature infants receiving very early full human milk feeding. Pediatrics. 2005 Mar;115(3):e269-76. doi: 10.1542/peds.2004-1833. Epub 2005 Feb 1.'}, {'pmid': '20433368', 'type': 'BACKGROUND', 'citation': 'Lai CT, Hale TW, Simmer K, Hartmann PE. Measuring milk synthesis in breastfeeding mothers. Breastfeed Med. 2010 Jun;5(3):103-7. doi: 10.1089/bfm.2009.0074.'}, {'type': 'BACKGROUND', 'citation': 'Amornlerdpison D CV, Narkprasom K, Yimyam S. Bioactive Compounds and Antioxidant Properties of Banana Inflorescence in a Beverage for Maternal Breastfeeding. Applied Sciences. 2020; 11(1):343.'}, {'pmid': '1478613', 'type': 'BACKGROUND', 'citation': 'Koduri PB, Rillema JA. Saponin effects of prolactin-like stimulation of ornithine decarboxylase activity in mouse mammary gland explants. Horm Metab Res. 1992 Dec;24(12):562-4. doi: 10.1055/s-2007-1003390.'}, {'pmid': '27988402', 'type': 'BACKGROUND', 'citation': 'Mathew NS, Negi PS. Traditional uses, phytochemistry and pharmacology of wild banana (Musa acuminata Colla): A review. J Ethnopharmacol. 2017 Jan 20;196:124-140. doi: 10.1016/j.jep.2016.12.009. Epub 2016 Dec 14.'}, {'pmid': '23146802', 'type': 'BACKGROUND', 'citation': 'Mahmood A, Omar MN, Ngah N. Galactagogue effects of Musa x paradisiaca flower extract on lactating rats. Asian Pac J Trop Med. 2012 Nov;5(11):882-6. doi: 10.1016/S1995-7645(12)60164-3.'}, {'pmid': '17409102', 'type': 'BACKGROUND', 'citation': 'Slusher T, Slusher IL, Biomdo M, Bode-Thomas F, Curtis BA, Meier P. Electric breast pump use increases maternal milk volume in African nurseries. J Trop Pediatr. 2007 Apr;53(2):125-30. doi: 10.1093/tropej/fml066.'}, {'pmid': '11517200', 'type': 'BACKGROUND', 'citation': 'Jones E, Dimmock PW, Spencer SA. A randomised controlled trial to compare methods of milk expression after preterm delivery. Arch Dis Child Fetal Neonatal Ed. 2001 Sep;85(2):F91-5. doi: 10.1136/fn.85.2.f91.'}, {'pmid': '23623976', 'type': 'BACKGROUND', 'citation': 'Geddes D, Hartmann P, Jones E. Preterm birth: Strategies for establishing adequate milk production and successful lactation. Semin Fetal Neonatal Med. 2013 Jun;18(3):155-159. doi: 10.1016/j.siny.2013.04.001. Epub 2013 Apr 26.'}, {'pmid': '32421208', 'type': 'RESULT', 'citation': 'Foong SC, Tan ML, Foong WC, Marasco LA, Ho JJ, Ong JH. Oral galactagogues (natural therapies or drugs) for increasing breast milk production in mothers of non-hospitalised term infants. Cochrane Database Syst Rev. 2020 May 18;5(5):CD011505. doi: 10.1002/14651858.CD011505.pub2.'}, {'type': 'RESULT', 'citation': 'Nordin ZM BI, Omar MN, Mahmood A. Effect of consuming lactogenic biscuits formulated with banana (Musa x paradisiaca) flower flour on expressed breast milk (EBM) among lactating working women. Food Research 2019;4(2):294-300.'}, {'pmid': '33202169', 'type': 'RESULT', 'citation': 'Khorana M, Wongsin P, Torbunsupachai R, Kanjanapattanakul W. Effect of Domperidone on Breast Milk Production in Mothers of Sick Neonates: A Randomized, Double-Blinded, Placebo-Controlled Trial. Breastfeed Med. 2021 Mar;16(3):245-250. doi: 10.1089/bfm.2020.0234. Epub 2020 Nov 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Postpartum women of preterm newborns\n\nExclusion Criteria:\n\n* Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast.\n* Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage.\n* Postpartum women with allergy to banana blossom.\n* Postpartum women with previous breast surgery or nipple surgery.\n* Postpartum women who smoking.\n* Preterm newborns with unstable conditions.'}, 'identificationModule': {'nctId': 'NCT05465460', 'briefTitle': 'Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns', 'organization': {'class': 'OTHER', 'fullName': 'Chulalongkorn University'}, 'officialTitle': 'Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial', 'orgStudyIdInfo': {'id': '667/2022'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Banana blossom', 'description': 'Participants received banana blossom 225 mg tablet orally four time per day for 14 days.', 'interventionNames': ['Drug: Banana Blossom']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants received placebo tablet orally four time per day for 14 days.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Banana Blossom', 'type': 'DRUG', 'description': 'Banana Blossom 225 mg tablet orally four times per day for 14 days', 'armGroupLabels': ['Banana blossom']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo tablet orally four times per day for 14 days', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10330', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Vorapong Phupong', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}], 'overallOfficials': [{'name': 'Vorapong Phupong, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chulalongkorn University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Vorapong Phupong', 'investigatorFullName': 'Vorapong Phupong', 'investigatorAffiliation': 'Chulalongkorn University'}}}}