Tokyo, March 19 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060976) titled 'A study of changes in breast milk lipid components after childbirth' on March 18.

Study Type: Observational

Primary Sponsor: Institute - Meiji Holdings Co., Ltd.

Condition: Condition - Healthy mothers and their children Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - Evaluate longitudinal changes in breast milk lipid components between 1 month and 6 months after childbirth. Basic objectives2 - Others

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Mother-infant pairs who were participants in the primary study (UMIN000050032) 2. Mother-infant pairs who delivered between 37 weeks 0 days and 41 weeks 6 days of gestation 3. Mother-infant pairs in which the infant's birth weight was 2500 g or greater 4. Mother-infant pairs who provided breast milk samples at both 1 month postpartum (30 +/- 14 days) and 6 months postpartum (180-239 days) 5. Mother-infant pairs who were practicing mixed feeding at both 1 and 6 months postpartum 6. Mother-infant pairs in which the mother's BMI was at least 18.5 and less than 25 before pregnancy and at both 1 and 6 months postpartum, at the time of breast milk collection 7. Mother-infant pairs in which the mother answered "No" to the question "Have you been diagnosed with an infectious disease as defined in Article 6 of the Act on the Prevention of Infectious Diseases and Medical Care for Patients with Infectious Diseases?" at the time of breast milk collection Key exclusion criteria - 1. Mother-infant pairs who expressed their intention to withdraw from participation after the public disclosure of information regarding the conduct of this study 2. Mother-infant pairs with missing data for one or more of the variables collected in this study 3. Mother-infant pairs in which the mother had a history of atopy or allergy 4. Mother-infant pairs in which the mother had mastitis at the time of breast milk collection 5. Mother-infant pairs in which the mother had nipple bleeding at the time of breast milk collection 6. Mother-infant pairs in which the mother had a smoking habit 7. Mother-infant pairs in which the interval between the date of breast milk collection and the response date for the BDHQ questionnaire (body weight entry) exceeded 2 weeks at either or both of the 1 month and 6 month postpartum assessments Target Size - 20

Recruitment Status: Recruitment status - No longer recruiting Date of protocol fixation - 2024 Year 10 Month 30 Day Date of IRB - 2024 Year 11 Month 15 Day Anticipated trial start date - 2025 Year 04 Month 03 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069776

Disclaimer: Curated by HT Syndication.