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

NCT ID: NCT05465460

Last Updated: 2024-02-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-13

Study Completion Date

2023-08-31

Brief Summary

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

Detailed Description

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Conditions

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Preterm Birth Postpartum Women

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Banana blossom

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

Group Type ACTIVE_COMPARATOR

Banana Blossom

Intervention Type DRUG

Banana Blossom 225 mg tablet orally four times per day for 14 days

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo tablet orally four times per day for 14 days

Interventions

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Banana Blossom

Banana Blossom 225 mg tablet orally four times per day for 14 days

Intervention Type DRUG

Placebo

Placebo tablet orally four times per day for 14 days

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Vorapong Phupong

Prof. Vorapong Phupong

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vorapong Phupong, M.D.

Role: STUDY_DIRECTOR

Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology

Locations

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Vorapong Phupong

Bangkok, , Thailand

Site Status

Countries

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Thailand

References

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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.

Reference Type BACKGROUND
PMID: 15681632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30776448 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15687416 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 20433368 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 1478613 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27988402 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23146802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17409102 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11517200 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23623976 (View on PubMed)

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.

Reference Type RESULT
PMID: 32421208 (View on PubMed)

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.

Reference Type RESULT

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.

Reference Type RESULT
PMID: 33202169 (View on PubMed)

Other Identifiers

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667/2022

Identifier Type: -

Identifier Source: org_study_id

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