Comparative Nutrient Composition of Preterm and Term Human MilkNCT07399405
Comparison of Nutrient Content Between Preterm and Term Human Milk: a Systematic Review and Meta-analysis
An observational study of Comparative Nutrient Composition of Preterm and Term Human Milk, run by Sun Yat-sen University at 1 site in China.
Trial summary
The purpose of this study is to thoroughly evaluate nutrient disparities between preterm and term human milk. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Comparative Nutrient Composition of Preterm and Term Human Milk
- What is being tested?
- observational study
- How many people
- 102 participants
- Where
- 1 siteChina
- Study dates
- 6 Jul 2022to 12 Sep 2025
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Among these studies, most of them were performed in Europe. The sample size ranged from 10 to 2,633, with a median sample size of 49. All studies provided comparative data from mothers who delivered preterm and term infants, with gestational age consistently categorized as preterm (<37 weeks) and term (≥37 weeks). The stage of lactation at sample collection (including colostrum, transitional, and mature milk) was reported in most studies.
Who may be able to join
- Studies needed to be population-based observational designs and report nutrient composition data for both preterm and term human milk. They must clearly define gestational age (preterm: 25-36 weeks; term: 37-42 weeks) and examine at least one comparable nutrient in both groups, such as energy, macronutrients (such as protein, fat, lactose), and/or micronutrients (including minerals like calcium and phosphorus, and vitamins such as vitamin D). We included articles published in Chinese or English only.
Who cannot join
- Studies were excluded if they focused solely on mothers with specific medical conditions (such as malnutrition, mastitis, or diabetes), if they involved nutrient supplementation as an intervention, or if they were published in languages other than Chinese or English.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to thoroughly evaluate nutrient disparities between preterm and term human milk.
Read the detailed description
Preterm birth (gestational age of less than 37 weeks) is a major global health issue, associated with a high burden of mortality and long-term morbidity. Achieving optimal nutrition is critical for improving outcomes in this vulnerable population. However, the specific nutritional requirements for supporting postnatal growth akin to intrauterine rates are exceptionally high. While human milk is the recommended foundation of nutrition, its unfortified use may not meet these demands, and common alternatives like preterm formula present a balance of potential benefits and risks. Crucially, formulating effective nutritional strategies hinges on a precise understanding of the composition of preterm human milk itself. Existing evidence on this composition, especially regarding micronutrients and their influencing factors, is inconsistent and incomplete. Prior reviews have largely focused on macronutrients, leaving a gap in the synthesized evidence regarding micronutrient levels and their key determinants. Therefore, we performed this systematic review and meta-analysis to quantitatively compare the nutrient profile of preterm and term human milk and to evaluate the influence of factors such as lactation stage on these differences.
- Being tested
- observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
This study is a systematic review and meta-analysis. No intervention is administered to participants. Data regarding human milk composition are extracted and synthesized from previously published observational studies.
| Study group | Role | What they receive |
|---|---|---|
| lactating mothers or mothers providing human milk | Not described Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Energy content in human milk
The energy content in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Protein in human milk
The concentration of protein in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Fat in human milk
The concentration of fat in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lactose in human milk
The concentration of lactose in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Secondary outcomes (21)
Concentration of IgA in human milk
The concentration of IgA in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Total nitrogen in human milk
The concentration of total nitrogen in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lysozyme in human milk
The concentration of lysozyme in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lactoferrin in human milk
The concentration of lactoferrin in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lactalbumin in human milk
The concentration of lactalbumin in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Albumin in human milk
The concentration of albumin in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Sodium in human milk
The concentration of sodium in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Potassium in human milk
The concentration of potassium in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Calcium in human milk
The concentration of calcium in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Magnesium in human milk
The concentration of magnesium in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Phosphorus in human milk
The concentration of phosphorus in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Zinc in human milk
The concentration of zinc in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Copper in human milk
The concentration of copper in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Iron in human milk
The concentration of iron in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Iodine in human milk
The concentration of iodine in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Selenium in human milk
The concentration of selenium in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Manganese in human milk
The concentration of manganese in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Molybdenum in human milk
The concentration of molybdenum in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin E in human milk
The concentration of vitamin E in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin A in human milk
The concentration of vitamin A in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin B6 in human milk
The concentration of vitamin B6 in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Measured: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start6 Jul 2022
- Primary completion8 Jul 2024
- Study completion12 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Comparative Nutrient Composition of Preterm and Term Human MilkStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Li Cai, PhD, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399405
- Sponsor's protocol ID
- HMP
- Status last verified
- Feb 2026
- First submitted
- 3 Feb 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Nutrient Content Between Preterm and Term Human Milk: a Systematic Review and Meta-analysis
- ClinicalTrials.gov ID
- NCT07399405
- Acronym / sponsor ID
- HMP
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 6 Jul 2022 (actual)
- Primary completion
- 8 Jul 2024 (actual)
- Study completion
- 12 Sep 2025 (actual)
- First posted
- 10 Feb 2026 (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 thoroughly evaluate nutrient disparities between preterm and term human milk.
Detailed description
Preterm birth (gestational age of less than 37 weeks) is a major global health issue, associated with a high burden of mortality and long-term morbidity. Achieving optimal nutrition is critical for improving outcomes in this vulnerable population. However, the specific nutritional requirements for supporting postnatal growth akin to intrauterine rates are exceptionally high. While human milk is the recommended foundation of nutrition, its unfortified use may not meet these demands, and common alternatives like preterm formula present a balance of potential benefits and risks. Crucially, formulating effective nutritional strategies hinges on a precise understanding of the composition of preterm human milk itself. Existing evidence on this composition, especially regarding micronutrients and their influencing factors, is inconsistent and incomplete. Prior reviews have largely focused on macronutrients, leaving a gap in the synthesized evidence regarding micronutrient levels and their key determinants. Therefore, we performed this systematic review and meta-analysis to quantitatively compare the nutrient profile of preterm and term human milk and to evaluate the influence of factors such as lactation stage on these differences.
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lactating mothers or mothers providing human milk | – | Other: observational study |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Among these studies, most of them were performed in Europe. The sample size ranged from 10 to 2,633, with a median sample size of 49. All studies provided comparative data from mothers who delivered preterm and term infants, with gestational age consistently categorized as preterm (<37 weeks) and term (≥37 weeks). The stage of lactation at sample collection (including colostrum, transitional, and mature milk) was reported in most studies.
Key inclusion criteria (1 listed)
- Studies needed to be population-based observational designs and report nutrient composition data for both preterm and term human milk. They must clearly define gestational age (preterm: 25-36 weeks; term: 37-42 weeks) and examine at least one comparable nutrient in both groups, such as energy, macronutrients (such as protein, fat, lactose), and/or micronutrients (including minerals like calcium and phosphorus, and vitamins such as vitamin D). We included articles published in Chinese or English only.
Key exclusion criteria (1 listed)
- Studies were excluded if they focused solely on mothers with specific medical conditions (such as malnutrition, mastitis, or diabetes), if they involved nutrient supplementation as an intervention, or if they were published in languages other than Chinese or English.
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 |
|---|---|---|
| observational studyThis study is a systematic review and meta-analysis. No intervention is administered to participants. Data regarding human milk composition are extracted and synthesized from previously published observational studies. | Other | lactating mothers or mothers providing human milk |
Primary outcome
Energy content in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
The energy content in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Concentration of Protein in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
The concentration of protein in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Concentration of Fat in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
The concentration of fat in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
Concentration of Lactose in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
The concentration of lactose in human milk. Data will be extracted from included observational studies and expressed as mean ± standard deviation for comparison between preterm and term groups.
21 secondary outcomes
Concentration of IgA in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Total nitrogen in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lysozyme in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lactoferrin in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Lactalbumin in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Albumin in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Sodium in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Potassium in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Calcium in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Magnesium in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Phosphorus in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Zinc in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Copper in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Iron in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Iodine in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Selenium in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Manganese in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Molybdenum in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin E in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin A in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
Concentration of Vitamin B6 in human milk
Time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Comparative Nutrient Composition of Preterm and Term Human Milk, run by Sun Yat-sen University at 1 site in China.
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 1 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 20 Aug 2026. 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 China. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Energy content in human milk (time frame: Human milk samples are collected during the defined lactation periods. Specifically, colostrum is defined as samples collected within 3-5 days postpartum, transitional milk within 7-14 days postpartum, and mature milk at ≥15 days postpartum.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2026.