Human Milk Profiles and Dietary Intake of Chinese Lactating Mothers During Early Lactation Period in Shanghai

Launched by DUMEX BABY FOOD CO., LTD. · Feb 23, 2014

Keywords

ClinConnect Summary

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Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Generally healthy mothers who give birth to a healthy term infant (37-42 weeks) whose birth weight is \>10 and \<90 percentiles gestational birth weight chart.
• • Aged 20 - 40 years.
• • Mothers who intend to exclusively breastfeed the infant for more than 6 weeks.
• • Chinese ethnicity, including both parents.
• • Mothers who sign the informed consent form in writing.
• Exclusion Criteria:
• Mothers:
• • Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
• • Difficult to follow up and/or locate (e.g. known transfer to other hospitals, residing outside Shanghai, plan to move out of Shanghai).
• • Current smoker or having smoked during the pregnancy.
• • Having consumed alcoholic drinks during pregnancy or lactation.
• • Illegal drug abuser: cannabinoids (marijuana, hashish), stimulants (cocaine, amphetamine, methamphetamine), opioid (heroin, opium).
• • Acute infection disease or neoplastic disease or any kind of weakening or debilitating conditions (no history of positive HBV, HCV or HIV serological test at any time during the pregnancy).
• • Use of drug or pharmacologically active substances (e.g. herbal products, traditional medicine) to treat a particular disease or medical condition from the beginning of lactation ( those who consume herbal/traditional medicine for maintaining or improving well-being will still be included).
• • Presence of mastitis, fungal infections of the nipple or areola; reactivation of herpes simplex (HSV) or varicella zoster infection in the mammary or thoracic region at the time of enrolment.
• • Presence of endocrinology diseases, particularly diabetes mellitus and gestational diabetes.
• • Presence of obesity (pre-pregnancy BMI \> 28).
• • Presence of chronic diseases such as cardiovascular, renal, respiratory and hepatic diseases.
• • Presence of psychosis and severe post-partum depression.
• • Presence of autoimmune disease such as systemic lupus erythematosus, systemic scleroderma, ulcerative colitis, Crohn's disease, celiac disease.
• • Women whose health condition, according to the investigator's judgement, could interfere with the study conduct and assessment.
• • Mothers who have given birth to twins or multiples or infant conceived with Assisted Reproductive Technology (ART).
• • Elimination diet due to chronic allergic diseases or vegan.
• • Incapability of subject to comply with study protocol or investigator's uncertainty about the willingness or ability of the mothers to understand and comply with the protocol requirements.
• Infants:
• • Any congenital abnormality, chromosomal disorder or severe disease which could interfere with the study conduct and assessment.