Preterm BirthPhase 4NCT05465460
Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns
A Phase 4 study testing Banana Blossom in people with Preterm Birth and Postpartum Women, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Postpartum Women
- What is being tested?
- Banana Blossom
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 13 Jul 2022to 31 Aug 2023
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Postpartum women of preterm newborns
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial
The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume
- Conditions
- Preterm Birth, Postpartum Women
- Being tested
- Banana Blossom, Placebo
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Banana BlossomDrug
Banana Blossom 225 mg tablet orally four times per day for 14 days
PlaceboDrug
Placebo tablet orally four times per day for 14 days
| Study group | Role | What they receive |
|---|---|---|
| Banana blossom | Active comparator | Participants received banana blossom 225 mg tablet orally four time per day for 14 days. Receives: Drug: Banana Blossom |
| Placebo | Placebo comparator | Participants received placebo tablet orally four time per day for 14 days. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breast milk volume per day at day 14
Breast milk volume measurement in milliliters
Measured: at day 14
Breast milk volume per day at day 3
Breast milk volume measurement in milliliters
Measured: at day 3
Breast milk volume per day at day 7
Breast milk volume measurement in milliliters
Measured: at day 7
Secondary outcomes (4)
percentage of good satisfaction
satisfaction evaluated by 5 Likert scales
Measured: at 14 days
percentage of side effects during intervention
percentage of participants with side effects such as headache, nausea/vomiting assessing by asking
Measured: day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
percentage of drug compliance
percentage of complete drug use assessing by remained drug counting
Measured: at 14 days
factors associated with increasing breast milk volume
factors associated with increasing breast milk volume assessing by univariate and multivariate analysis
Measured: at 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2022
- Study start13 Jul 2022
- Primary completion31 Aug 2023
- Study completion31 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Preterm BirthStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vorapong Phupong, Chulalongkorn University
- Investigators
- Vorapong Phupong, M.D., Study director, Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05465460
- Sponsor's protocol ID
- 667/2022
- Status last verified
- Feb 2024
- First submitted
- 7 Jul 2022
- Last updated
- 7 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 15681632Yu 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.
PubMed 30776448Ronnestad 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.
PubMed 15687416Lai 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.
PubMed 20433368Amornlerdpison 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.
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.
PubMed 1478613Mathew 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.
PubMed 27988402Mahmood 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.
PubMed 23146802Slusher 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.
PubMed 17409102Jones 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.
PubMed 11517200Geddes 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.
PubMed 23623976Foong 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.
PubMed 32421208Nordin 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.
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.
PubMed 33202169
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Banana Blossom on Breast Milk Volume in Mothers of Preterm Newborns, a Randomized, Double Blinded, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT05465460
- Acronym / sponsor ID
- 667/2022
- Conditions
- Preterm Birth, Postpartum Women
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 13 Jul 2022 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 19 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the effect of banana blossom in increasing breast milk volume
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Banana blossom | Active comparator | Drug: Banana BlossomParticipants received banana blossom 225 mg tablet orally four time per day for 14 days. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants received placebo tablet orally four time per day for 14 days. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Postpartum women of preterm newborns
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Banana BlossomBanana Blossom 225 mg tablet orally four times per day for 14 days | Drug | Banana blossom |
| PlaceboPlacebo tablet orally four times per day for 14 days | Drug | Placebo |
Primary outcome
Breast milk volume per day at day 14
Time frame: at day 14
Breast milk volume measurement in milliliters
Breast milk volume per day at day 3
Time frame: at day 3
Breast milk volume measurement in milliliters
Breast milk volume per day at day 7
Time frame: at day 7
Breast milk volume measurement in milliliters
4 secondary outcomes
percentage of good satisfaction
Time frame: at 14 days
percentage of side effects during intervention
Time frame: day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
percentage of drug compliance
Time frame: at 14 days
factors associated with increasing breast milk volume
Time frame: at 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2024.
- Background: PubMed 15681632Hill 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.
- Background: PubMed 30776448Yu 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.
- Background: PubMed 15687416Ronnestad 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.
- Background: PubMed 20433368Lai 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.
- BackgroundAmornlerdpison 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.
- Background: PubMed 1478613Koduri 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.
- Background: PubMed 27988402Mathew 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.
- Background: PubMed 23146802Mahmood 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.
- Background: PubMed 17409102Slusher 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.
- Background: PubMed 11517200Jones 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.
- Background: PubMed 23623976Geddes 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 publication: PubMed 32421208Foong 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vorapong Phupong, M.D. study director
Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Banana Blossom in people with Preterm Birth and Postpartum Women, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breast milk volume per day at day 14 (time frame: at day 14). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05465460, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2024.