Guangzhou Preterm and Term Birth Cohort Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Offspring Length/Height (cm)
Study Overview
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.
Detailed Description
The Guangzhou Preterm-Term Birth Cohort (GPTBC) is a single-center, prospective longitudinal observational study conducted at the Third Affiliated Hospital of Guangzhou Medical University. Mothers and their preterm or term infants were enrolled within 7 days after delivery and are followed primarily through 24 months of age; a subset receives additional follow-up beyond 24 months. The cohort was designed to recruit approximately equal numbers of preterm and term infants to characterize early-life exposures and health trajectories and to assess whether preterm birth modifies exposure-outcome associations.
The primary scientific focus is how human milk composition and other early-life nutritional and environmental exposures relate to infant growth, neuropsychological development, allergic diseases, and gut microbiome development. Serial human milk samples support measurements of nutritional components, 23 targeted human milk oligosaccharides, selected bioactive proteins, fatty acids, metabolomic and lipidomic profiles, microbial metagenomes, and exposomic profiles of environmental contaminants. Infant stool samples are analyzed using metagenomic sequencing. Additional stored biospecimens support related current and future research.
Repeated questionnaires capture maternal postpartum health, diet, lifestyle, psychological status, medication use, and breastfeeding; infant feeding, supplementation, illness, medication use, sleep, activity, screen exposure, and caregiving environment; and selected paternal and family characteristics. Child health is assessed longitudinally using anthropometry, standardized developmental assessments, eye tracking, parental reports of physician-diagnosed allergic diseases, and microbiome measures.
The study will examine exposure patterns and their changes over time, associations with maternal and child health, potential biological pathways, and differences between preterm and term infants.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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).
Exclusion Criteria
- •Critical illness during pregnancy requiring admission to the intensive care unit.
- •Unwilling or unable to breastfeed.
Arms & Interventions
Preterm Birth Group
Mother-infant pairs in which the infant was born at 32 weeks 0 days to 36 weeks 6 days of gestation.
Intervention: No Intervention: Observational Cohort (Other)
Term Birth Group
Mother-infant pairs in which the infant was born at 37 weeks 0 days to 41 weeks 6 days of gestation.
Intervention: No Intervention: Observational Cohort (Other)
Outcomes
Primary Outcomes
Offspring Length/Height (cm)
Time Frame: Birth, 1 months, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.
Offspring length or height measured by a pediatrician.
Offspring Weight (kg)
Time Frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Offspring weight measured using a calibrated scale.
Offspring Head Circumference (cm)
Time Frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Offspring head circumference measured by a pediatrician.
Offspring Body Mass Index (kg/m²)
Time Frame: Birth, 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Calculated as weight (kg) divided by the square of length or height (in meters).
Neurodevelopmental outcome - Gesell Developmental Schedules (GDS)
Time Frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.
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.
Neurodevelopmental outcome - Ages and Stages Questionnaires (ASQ)
Time Frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
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.
Secondary Outcomes
- 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.)
- Social Cognitive Attention Patterns - Fixation Duration Proportion (%)(6 months, 8 months, 12 months of age.)
- Number of Participants with Physician-Diagnosed Allergic Diseases(1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.)
Investigators
Li Cai, PhD
Principal Investigator
Sun Yat-sen University