An observational study in Preterm Infant and Gut Microbiome, sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. Recruiting at 1 site in China. Open to participants aged 1 Day to 4 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-17.
Sponsored by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · 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 31st largest by planned enrollment of the 35 observational ones that give a count, is one of 5 that started in 2014, is one of 35 observational ones, reaches primary completion later than 11 of the 30 other live ones, and was the 17th registered.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
Browse Premature Birth studies →26 of the 79 studies in Premature Birth with a site in China are open now. Recruiting first, the newest first:
Guangzhou Women and Children's Medical Center · Sites in China
Children's Hospital of Fudan University · Sites in China
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University · Sites in China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine · Sites in China
The Children's Hospital of Zhejiang University School of Medicine · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
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: 1 Day to 4 Months · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
79 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 7 · Phase 3 5 · Phase 4 8
First in 2006; this study’s year is marked. 5 started in 2014.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 102 is below the median of 120 across 806 observational studies indexed under Premature Birth.
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.
This tab as a report to print or save as PDF → With an account.
4 of 79 have an industry lead sponsor. The 10 most frequent:
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine is the lead sponsor of 225 studies on the registry; 55 are open to participants now.
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine has 7 studies filed under Premature Birth — fewer than ten, so there is no comparison to draw.
9 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 |
| 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 |
| NCT04777760Daping Hospital and the Research Institute of Surgery of the Third Military Medical UniversitySurfactant for Neonatal Respiratory Distress Syndrome(NRDS) and Neonatal Acute Respiratory Distress Syndrome(NARDS) | 2026-12-31 |
Among the 79 studies in Premature Birth with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
The aim of this study is to obtain a longitudinal view of the gut microbial establishment of a cohort of 51 preterm (PT) infants compared to 50 full-term (FT) infants from birth to 90 days of age, and to identify key clinical factors that affect the establishment of neonatal microbiome.
The hypothesis of the investigators is that the gut microbiota progression of PT group and FT group is different in diversity and composition. Antibiotics and its usage duration is likely the main factor disturbing the colonization and development of the gut microbiome of PT infants.
Premature birth is a global clinical problem. Early colonization and development of the neonatal gut microbiome is critically important with a profound impact on the host lifelong health. V3-V4 region of 16S rRNA amplicons of 581 stool DNA will be sequenced from a cohort of 51 PT infants and 50 FT infants to examine the microbial profiles. A random-effects generalized least square regression model is used to compare the difference in the main bacterial groups over time with the adjustment for multiple variables including gestational age and use of antibiotics .
About 50 preterm infants and 50 full-term healthy infants
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.
Preterm infants
Exclusion criteria:
Control group:
changes in gut microbiota over time and in relation to antibiotic treatment
Fecal DNA at different time points to measure the gut microbiota of preterm infants and full-term infants to investigate the development of early microbial colonization and the impact of antibiotics on the early life of preterm infants
Time frame: 0-7 years after birth
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2014 (actual). Primary completion is estimated for Nov 2026, 147 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 147 months is above 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.
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Xinhua Hospital, Shanghai Jiao Tong University School of Medicine →