Preterm BirthGPTBCNCT07756177
Guangzhou Preterm and Term Birth Cohort Study
An observational study of Preterm Birth and Neurodevelopmental Disorders, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Preterm Birth, Neurodevelopmental Disorders, Overweight
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 21 Nov 2023to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Mother-infant pairs (term and preterm).
Who may be able to join
- 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).
Who cannot join
- Critical illness during pregnancy requiring admission to the intensive care unit.
- Unwilling or unable to breastfeed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- No Intervention: Observational Cohort
- 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
- Medical subject headings
- Premature Birth, Neurodevelopmental Disorders, Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No Intervention: Observational CohortOther
This cohort study have any no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Birth Group | Mother-infant pairs in which the infant was born at 32 weeks 0 days to 36 weeks 6 days of gestation. Receives: 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. Receives: Other: No Intervention: Observational Cohort |
What is being measured
The primary outcome is the main question the study is designed to answer.
Offspring Length/Height (cm)
Offspring length or height measured by a pediatrician.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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)
Number of trials in which the fixation duration on specific Areas of Interest (social and non-social) exceeds 30% of the total fixation duration on the entire screen, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator indicates adequate attentional engagement with the presented social and non-social stimuli.
Measured: 6 months, 8 months, and 12 months of age.
Social Cognitive Attention Patterns - First Fixation Count (number)
Number of times the first fixation following stimuli onset lands on specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator captures initial attentional orienting and reflects the salience of the presented social and non-social stimuli.
Measured: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - First Fixation Duration (seconds)
Duration (in seconds) of the first fixation within specific Areas of Interest (social and non-social) following stimulus onset, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects early-stage attentional processing and the efficiency of initial stimulus engagement.
Measured: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Total Fixation Count (number)
Total number of discrete fixation events occurring within specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects the overall frequency of attentional engagement with the presented social and non-social stimuli.
Measured: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Total Fixation Duration (seconds)
Cumulative duration (in seconds) of all fixations occurring within specific Areas of Interest (social and non-social), measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects overall attentional allocation to the presented social and non-social stimuli.
Measured: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Fixation Duration Proportion (%)
Percentage of total fixation time allocated to social or non-social Areas of Interest, calculated as (total fixation time on social or non-social Areas of Interest / total fixation time on all Areas of Interest) × 100, measured using a Tobii Pro Spectrum eye-tracker across biological motion, joint attention, and visual preference paradigms. This eye-tracking indicator reflects relative attentional preference between social and non-social stimuli.
Measured: 6 months, 8 months, 12 months of age.
Number of Participants with Physician-Diagnosed Allergic Diseases
Number of participants who experience at least one episode of physician-diagnosed allergic diseases during the follow-up period, including eczema or atopic dermatitis, cow's milk protein allergy, other food allergies, allergic rhinitis, and asthma, as diagnosed by a physician and reported by parents, and confirmed by medical records.
Measured: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2026
- Study start21 Nov 2023
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preterm BirthStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Principal investigator, Li Cai, PhD, Sun Yat-sen University
- Investigators
- Li Cai, Ph.D, Principal investigator, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07756177
- Sponsor's protocol ID
- GPTBC
- Acronym
- GPTBC
- Status last verified
- Jul 2026
- First submitted
- 14 Apr 2026
- Last updated
- 10 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Guangzhou Preterm and Term Birth Cohort Study
- ClinicalTrials.gov ID
- NCT07756177
- Acronym / sponsor ID
- GPTBC / GPTBC
- Keywords
- Human Milk Composition, Osteopontin, Fatty acids, Human Milk Oligosaccharides, Infant Gut Microbiome, Human Milk Exposome, Metabolomics, Child Growth and Development
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- The Third Affiliated Hospital of Guangzhou Medical University
- Study start
- 21 Nov 2023 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Aug 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 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preterm Birth Group | – | Other: No Intervention: Observational CohortMother-infant pairs in which the infant was born at 32 weeks 0 days to 36 weeks 6 days of gestation. |
| Term Birth Group | – | Other: No Intervention: Observational CohortMother-infant pairs in which the infant was born at 37 weeks 0 days to 41 weeks 6 days of gestation. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Mother-infant pairs (term and preterm).
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (2 listed)
- Critical illness during pregnancy requiring admission to the intensive care unit.
- Unwilling or unable to breastfeed.
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 |
|---|---|---|
| No Intervention: Observational CohortThis cohort study have any no intervention. | Other | Preterm Birth Group, Term Birth Group |
Primary outcome
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.
7 secondary outcomes
Social Cognitive Attention Patterns - Sufficient Fixation Trials (number)
Time frame: 6 months, 8 months, and 12 months of age.
Social Cognitive Attention Patterns - First Fixation Count (number)
Time frame: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - First Fixation Duration (seconds)
Time frame: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Total Fixation Count (number)
Time frame: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Total Fixation Duration (seconds)
Time frame: 6 months, 8 months, 12 months of age.
Social Cognitive Attention Patterns - Fixation Duration Proportion (%)
Time frame: 6 months, 8 months, 12 months of age.
Number of Participants with Physician-Diagnosed Allergic Diseases
Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Aug 2026.
- Individual participant dataSharing planned: Undecided
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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.
Li Cai, Ph.D principal investigator
Sun Yat-sen University
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 Preterm Birth and Neurodevelopmental Disorders, 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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 10 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?
This study is still under way. Results are not available in the source record yet.
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?
Offspring Length/Height (cm) (time frame: Birth, 1 months, 3 months, 6 months, 8 months, 12 months, 18 months, and 24 months of age.). The study lists 6 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 10 Aug 2026.