Guangzhou Preterm and Term Birth Cohort Study

NCT07756177 | Active Not Recruiting

• 1 other identifier: GPTBC
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a prospective observational study of how early-life nutrition, environmental exposures, and family factors relate to the health and development of preterm and term infants and their mothers. Mother-infant pairs are followed from birth to 24 months. Researchers use questionnaires and biological samples to study human milk, microorganisms in the infant gut, physical growth, development, and allergic diseases, and whether these relationships differ between preterm and term infants. Findings may inform nutrition and health strategies for infants born at different gestational ages.

Conditions

Preterm Birth; Neurodevelopmental Disorders; Overweight; Obesity; Allergic Diseases

Keywords

Human Milk Composition; Osteopontin; Fatty acids; Human Milk Oligosaccharides; Infant Gut Microbiome; Human Milk Exposome; Metabolomics; Child Growth and Development; Neurodevelopment; Social Cognition; Visual Attention; Early-Life Nutrition; Maternal Diet; Preterm Birth; Term Birth

Outcome Measures

Primary Outcomes (6)

• Offspring Length/Height (cm)

  Offspring length or height measured by a pediatrician.

  Birth, 1 months, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.

• Offspring Weight (kg)

  Offspring weight measured using a calibrated scale.

  Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

• Offspring Head Circumference (cm)

  Offspring head circumference measured by a pediatrician.

  Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

• Offspring Body Mass Index (kg/m²)

  Calculated as weight (kg) divided by the square of length or height (in meters).

  Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

• Neurodevelopmental outcome - Gesell Developmental Schedules (GDS)

  Developmental Quotients (DQ) for each developmental domain, assessed by the Gesell Developmental Schedules (GDS) administered by a pediatrician. DQ is calculated as (developmental age / chronological age or corrected age) × 100, with higher DQ indicating better development. Domains include: (1) adaptive, (2) gross motor, (3) fine motor, (4) language, and (5) personal-social.

  1 month, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.

• Neurodevelopmental outcome - Ages and Stages Questionnaires (ASQ)

  Parent-reported scores (0-60) for each developmental domain, assessed using the Ages and Stages Questionnaires (ASQ). Higher scores indicate better development. Domains include: (1) communication, (2) gross motor, (3) fine motor, (4) problem-solving, and (5) personal-social.

  1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.

Secondary Outcomes (7)

• Social Cognitive Attention Patterns - Sufficient Fixation Trials (number)

  6 months, 8 months, and 12 months of age.

• Social Cognitive Attention Patterns - First Fixation Count (number)

  6 months, 8 months, 12 months of age.

• Social Cognitive Attention Patterns - First Fixation Duration (seconds)

  6 months, 8 months, 12 months of age.

• Social Cognitive Attention Patterns - Total Fixation Count (number)

  6 months, 8 months, 12 months of age.

• Social Cognitive Attention Patterns - Total Fixation Duration (seconds)

  6 months, 8 months, 12 months of age.

Study Arms (2)

Preterm Birth Group

Mother-infant pairs in which the infant was born at 32 weeks 0 days to 36 weeks 6 days of gestation.

Other: No Intervention: Observational Cohort

Term Birth Group

Mother-infant pairs in which the infant was born at 37 weeks 0 days to 41 weeks 6 days of gestation.

Other: No Intervention: Observational Cohort

Interventions

No Intervention: Observational Cohort OTHER

This cohort study have any no intervention.

Preterm Birth Group; Term Birth Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Mother-infant pairs (term and preterm).

You may qualify if:

• Maternal age between 18 and 45 years.
• Resident in Guangzhou for at least one year.
• Gestational age at delivery ≥ 32 weeks and \< 42 weeks (moderate-to-late preterm or term births).

You may not qualify if:

• Critical illness during pregnancy requiring admission to the intensive care unit.
• Unwilling or unable to breastfeed.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• The Third Affiliated Hospital of Guangzhou Medical University: collaborator

Study Sites (1)

Sun Yat-sen University

Guangzhou, Guangdong, 510000, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biological specimens collected and retained in this cohort include human milk, breast skin swabs, and maternal and infant stool, hair, nail, and urine samples. These specimens support analyses of human milk composition and environmental exposures, the infant gut microbiome, and related maternal and child health outcomes, and may also be used for future related research.

MeSH Terms

Conditions

Premature Birth; Neurodevelopmental Disorders; Overweight; Obesity

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Mental Disorders; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Li Cai, Ph.D

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: August 10, 2026
• Study Start: November 21, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 10, 2026

Record last verified: 2026-07

Locations

CN (1)