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Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

Primary Purpose

Preterm Birth, Postpartum Women

Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Banana Blossom
Placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Preterm Birth

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Postpartum women of preterm newborns

Exclusion Criteria:

  • Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast.
  • Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage.
  • Postpartum women with allergy to banana blossom.
  • Postpartum women with previous breast surgery or nipple surgery.
  • Postpartum women who smoking.
  • Preterm newborns with unstable conditions.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Banana blossom

    Placebo

    Arm Description

    Participants received banana blossom 225 mg tablet orally four time per day for 14 days.

    Participants received placebo tablet orally four time per day for 14 days.

    Outcomes

    Primary Outcome Measures

    Breast milk volume per day at day 14
    Breast milk volume measurement in milliliters
    Breast milk volume per day at day 3
    Breast milk volume measurement in milliliters
    Breast milk volume per day at day 7
    Breast milk volume measurement in milliliters

    Secondary Outcome Measures

    percentage of good satisfaction
    satisfaction evaluated by 5 Likert scales
    percentage of side effects during intervention
    percentage of participants with side effects such as headache, nausea/vomiting assessing by asking
    percentage of drug compliance
    percentage of complete drug use assessing by remained drug counting
    factors associated with increasing breast milk volume
    factors associated with increasing breast milk volume assessing by univariate and multivariate analysis

    Full Information

    First Posted
    July 7, 2022
    Last Updated
    July 17, 2022
    Sponsor
    Chulalongkorn University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05465460
    Brief Title
    Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns
    Official Title
    Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 9, 2022 (Anticipated)
    Primary Completion Date
    August 31, 2023 (Anticipated)
    Study Completion Date
    September 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Preterm Birth, Postpartum Women

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Banana blossom
    Arm Type
    Active Comparator
    Arm Description
    Participants received banana blossom 225 mg tablet orally four time per day for 14 days.
    Arm Title
    Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Participants received placebo tablet orally four time per day for 14 days.
    Intervention Type
    Drug
    Intervention Name(s)
    Banana Blossom
    Intervention Description
    Banana Blossom 225 mg tablet orally four times per day for 14 days
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Intervention Description
    Placebo tablet orally four times per day for 14 days
    Primary Outcome Measure Information:
    Title
    Breast milk volume per day at day 14
    Description
    Breast milk volume measurement in milliliters
    Time Frame
    at day 14
    Title
    Breast milk volume per day at day 3
    Description
    Breast milk volume measurement in milliliters
    Time Frame
    at day 3
    Title
    Breast milk volume per day at day 7
    Description
    Breast milk volume measurement in milliliters
    Time Frame
    at day 7
    Secondary Outcome Measure Information:
    Title
    percentage of good satisfaction
    Description
    satisfaction evaluated by 5 Likert scales
    Time Frame
    at 14 days
    Title
    percentage of side effects during intervention
    Description
    percentage of participants with side effects such as headache, nausea/vomiting assessing by asking
    Time Frame
    day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
    Title
    percentage of drug compliance
    Description
    percentage of complete drug use assessing by remained drug counting
    Time Frame
    at 14 days
    Title
    factors associated with increasing breast milk volume
    Description
    factors associated with increasing breast milk volume assessing by univariate and multivariate analysis
    Time Frame
    at 14 days

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    45 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Postpartum women of preterm newborns Exclusion Criteria: Postpartum women with contraindication for breast feeding such as HIV, herpes zoster at breast, infected wound at breast. Postpartum women with preeclampsia, diabetes mellitus, postpartum hemorrhage. Postpartum women with allergy to banana blossom. Postpartum women with previous breast surgery or nipple surgery. Postpartum women who smoking. Preterm newborns with unstable conditions.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Apisit Rungruengsirichok, M.D.
    Phone
    +6626492115
    Email
    rung.apisit@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Vorapong Phupong, M.D.
    Phone
    +6626492115
    Email
    vorapong.p@chula.ac.th
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vorapong Phupong, M.D.
    Organizational Affiliation
    Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    15681632
    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.
    Results Reference
    background
    PubMed Identifier
    30776448
    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.
    Results Reference
    background
    PubMed Identifier
    15687416
    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.
    Results Reference
    background
    PubMed Identifier
    20433368
    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.
    Results Reference
    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.
    Results Reference
    background
    PubMed Identifier
    1478613
    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.
    Results Reference
    background
    PubMed Identifier
    27988402
    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.
    Results Reference
    background
    PubMed Identifier
    23146802
    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.
    Results Reference
    background
    PubMed Identifier
    17409102
    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.
    Results Reference
    background
    PubMed Identifier
    11517200
    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.
    Results Reference
    background
    PubMed Identifier
    23623976
    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.
    Results Reference
    background
    PubMed Identifier
    32421208
    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.
    Results Reference
    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.
    Results Reference
    result
    PubMed Identifier
    33202169
    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.
    Results Reference
    result

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    Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns

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