Clinical trial NCT05465460: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Preterm Birth
Postpartum Women
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2022-07-19
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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


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.

Primary outcomes:
measure: Breast milk volume per day at day 14
timeFrame: at day 14
measure: Breast milk volume per day at day 3
timeFrame: at day 3
measure: Breast milk volume per day at day 7
timeFrame: at day 7
Secondary outcomes:
measure: percentage of good satisfaction
timeFrame: at 14 days
measure: percentage of side effects during intervention
timeFrame: day 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14
measure: percentage of drug compliance
timeFrame: at 14 days
measure: factors associated with increasing breast milk volume
timeFrame: at 14 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Vorapong Phupong
Study officials:
affiliation: Chulalongkorn University, Faculty of Medicine, Department of Obstetrics and Gynecology
name: Vorapong Phupong, M.D.
role: STUDY_DIRECTOR
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