CompletedNot Applicable

A Cohort Study on Milk Composition, Health Outcomes, and Feeding Practices of Chinese Mothers and Infants

China769 participantsStarted 2021-11-19

Plain-language summary

This is a cohort study to understand the changes of breastmilk composition in the first six months after birth of Chinese infants.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Generally healthy mothers with the intention to breastfeed.
✓. Aged 18 years and above.
✓. Written informed consent.
✓. Generally healthy term born (gestational age between 37 and 42 weeks).
✓. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
✓. Chinese ethnicity of mother and father.

Exclusion criteria

✕. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
✕. Difficulty to follow up and/or locate (e.g. known transfer to other hospitals, residing outside the city where the study site is located, or planning to move out of the current city; incapability of mothers 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.
✕. Illegal drug use.
✕. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.
✕. A BMI of \<18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
✕. Acute infectious disease or neoplastic disease or any kind of weakening or debilitating conditions (with history of positive, hepatitis C virus (HCV) or HIV serological test at any time during the pregnancy).
✕. 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 chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases.

What they're measuring

Changes in human milk protein concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk fat concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk carbohydrate concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk energy content

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant length

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant head circumference

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant weight

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Trial details

NCT IDNCT05235412

SponsorDanone Nutricia

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2025-07-31

View on ClinicalTrials.gov More Breast Feeding trials

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. Generally healthy mothers with the intention to breastfeed.
✓. Aged 18 years and above.
✓. Written informed consent.
✓. Generally healthy term born (gestational age between 37 and 42 weeks).
✓. Breastfed by their mothers, either exclusively or in combination with infant milk formula, at enrolment.
✓. Chinese ethnicity of mother and father.

Exclusion criteria

✕. Participation in any other studies involving investigational or marketed products concomitantly or two weeks prior to entry into the study.
✕. Difficulty to follow up and/or locate (e.g. known transfer to other hospitals, residing outside the city where the study site is located, or planning to move out of the current city; incapability of mothers 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.
✕. Illegal drug use.
✕. Regular smoking and/ or consumption of alcoholic beverages as per investigator's judgement.
✕. A BMI of \<18.5 or ≥ 28 pre-pregnancy or during the first regular pregnancy check around or before 16 weeks of gestational age.
✕. Acute infectious disease or neoplastic disease or any kind of weakening or debilitating conditions (with history of positive, hepatitis C virus (HCV) or HIV serological test at any time during the pregnancy).
✕. 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 chronic diseases such as endocrine, cardiovascular, renal, respiratory or hepatic diseases.

What they're measuring

Changes in human milk protein concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk fat concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk carbohydrate concentration

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in human milk energy content

Timeframe: Human milk samples collected at 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant length

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant head circumference

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth

Changes in infant weight

Timeframe: Anthropometrics collected at birth, and 1 month, 3 month, 6 months, 12 months, 2 years after infant birth