Comparison of Nutrient Content Between Preterm and Term Human Milk: a Systematic Review and Meta-analysis

NCT07399405 | Completed

• 1 other identifier: HMP
• Study Type: observational
• Target: 103
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to thoroughly evaluate nutrient disparities between preterm and term human milk.

Conditions

Comparative Nutrient Composition of Preterm and Term Human Milk

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

lactating mothers or mothers providing human milk

Other: observational study

Interventions

observational study OTHER

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.

lactating mothers or mothers providing human milk

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, China

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2026
• First Posted: February 10, 2026
• Study Start: July 6, 2022
• Primary Completion: July 8, 2024
• Study Completion: September 12, 2025
• Last Updated: April 15, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)