An observational study in Preterm Birth, Neurodevelopmental Disorders and Overweight, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Sun Yat-sen University · Observational
Among 79 studies in Premature Birth with a site in China — 26 open to participants now, 31 under way, 2 of them phase 3. Premature Birth · China.
Among the 79 studies in Premature Birth with a site in China, this one is the 25th largest by planned enrollment of the 35 observational ones, is one of 5 that started in 2023, is one of 35 observational ones, reaches primary completion later than 13 of the 30 other live ones, and was the 73rd registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's planned enrollment of 200 is above the median of 120 across 806 observational studies indexed under Premature Birth.
Browse Premature Birth studies →26 of the 79 studies in Premature Birth with a site in China are open now, in 1 country. Each count lists the studies.
Of the 313 Premature Birth studies recruiting now, 87 (28%) set no upper age limit and 222 (71%) stop at 75 or younger; 239 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 45 Years · all sexes · healthy volunteers too.
The full table on the hub →79 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 5 started in 2023.
Median enrollment 195 across the 44 interventional studies, 541 across the 35 observational. Of the 31 that completed or were terminated, 1 (3%) have results posted.
4 of 79 have an industry lead sponsor. The 10 most frequent:
Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
Sun Yat-sen University has 2 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
10 of the studies in Premature Birth with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT03168516Phase 3University Hospital TuebingenEffects of Closed-loop Automatic Control of FiO2 in Extremely Preterm Infants | 2026-12 |
| NCT03373721Xinhua Hospital, Shanghai Jiao Tong University School of MedicineGut Microbiota of Preterm Infants and Full-term Infants at Early Life | 2026-11-01 |
| NCT06414655Peking University Third HospitalMulticenter Prospective Cohort Study of Twin Maternal-Child Dyads in China | 2026-11-30 |
| NCT07756177Sun Yat-sen UniversityGuangzhou Preterm and Term Birth Cohort Study | 2026-12-31 |
| NCT06234332Peking UniversityPeking University Birth Cohort in Weifang (PKUBC-WF) | 2026-12-31 |
Among the 79 studies in Premature Birth with a site in China, from their registry updates:
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.
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.
Mother-infant pairs (term and preterm).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
This cohort study have any no intervention.
Offspring Length/Height (cm)
Offspring length or height measured by a pediatrician.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 month, 3 months, 6 months, 8 months, 12 months, 18 months, 24 months of age.
Plan to share: Undecided
No publications or documents are linked to this record.
Started Nov 2023 (actual). Primary completion is estimated for Dec 2026, 37 months after the start.
Of 372 non-industry observational studies under Premature Birth, half reached primary completion within 35 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 63. This study's planned 37 months is close to that.
Counting every sponsor, half of 387 studies reached it within 35 months; a quarter within 18 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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