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

Preterm Birth Clinical Trial

Official title:

Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05465460
• Other study ID #: 667/2022
• Status: Completed
• Phase: Phase 4
• Start date: July 13, 2022
• Est. completion date: August 31, 2023

Study information

• Verified date: February 2024
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 31, 2023
• Est. primary completion date: August 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Postpartum Women
• Premature Birth
• Preterm Birth

Intervention

Drug:
• Banana Blossom
Banana Blossom 225 mg tablet orally four times per day for 14 days
• Placebo
Placebo tablet orally four times per day for 14 days

Locations

Country	Name	City	State
Thailand	Vorapong Phupong	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

References & Publications (14)

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.

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: 10.1002/1 — View 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. — View 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. — View 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. — View 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 — View 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. — View 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. — View 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. — View 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. — View 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.

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. — View 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. — View Citation

Yu X, Li J, Lin X, Luan D. Association between Delayed Lactogenesis ? 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. — View Citation

* Note: There are 14 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast milk volume per day at day 14	Breast milk volume measurement in milliliters	at day 14
Primary	Breast milk volume per day at day 3	Breast milk volume measurement in milliliters	at day 3
Primary	Breast milk volume per day at day 7	Breast milk volume measurement in milliliters	at day 7
Secondary	percentage of good satisfaction	satisfaction evaluated by 5 Likert scales	at 14 days
Secondary	percentage of side effects during intervention	percentage of participants with side effects such as headache, nausea/vomiting assessing by asking	day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
Secondary	percentage of drug compliance	percentage of complete drug use assessing by remained drug counting	at 14 days
Secondary	factors associated with increasing breast milk volume	factors associated with increasing breast milk volume assessing by univariate and multivariate analysis	at 14 days