PretermNCT07143825
A National Multicenter Survey on Small Vulnerable Newborns
An observational study of Preterm and Small Gestational Age (SGA), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
The goal of this nationwide multicenter observational study is to comprehensively investigate the severity of Small Vulnerable Newborns (SVN) issues across China and to propose further preventive and intervention measures. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Preterm, Small Gestational Age (SGA)
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2025to 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Small vulnerable newborns admitted to major hospitals across various regions of China in 2024
Who may be able to join
- Newborns diagnosed as vulnerable infants at the participating hospitals between January 1 and December 31, 2024;
- Meeting any one of the following criteria:
- Diagnosed as small for gestational age (SGA): birth weight below the 10th percentile for infants of the same gestational age and sex;
- Preterm infants: gestational age less than 37 weeks;
- Low Birth Weight (LBW) infants: birth weight less than 2,500 grams.
Who cannot join
- Incomplete medical records due to missing data preventing comprehensive case evaluation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
Yongjun Zhang, +86-13651736760, zhangyongjun@sjtu.edu.cn
About this study
Official title: A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China
The goal of this nationwide multicenter observational study is to comprehensively investigate the severity of Small Vulnerable Newborns (SVN) issues across China and to propose further preventive and intervention measures. The primary aim is to provide a thorough description of SVN problems using a unified definition and framework, and to develop targeted prevention strategies.
Participating centers across the country will collect clinical data on vulnerable newborns under their care and complete detailed questionnaires to support this research.
- Conditions
- Preterm, Small Gestational Age (SGA)
- Medical subject headings
- Premature Birth
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of small vulnerable newborns
Measured: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
Mortality rate
Measured: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
Secondary outcomes (1)
Incidence of complications in small vulnerable newborns
Including mechanical ventilation, bronchopulmonary dysplasia, congenital heart defects, congenital gastrointestinal malformations, retinopathy of prematurity, periventricular-intraventricular hemorrhage, periventricular leukomalacia, neonatal sepsis, and neonatal bacterial meningitis.
Measured: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2025
- Study start1 Apr 2025
- Primary completion31 Dec 2025 (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 PretermStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07143825
- Sponsor's protocol ID
- XH-25-006
- Status last verified
- Aug 2025
- First submitted
- 12 Aug 2025
- Last updated
- 27 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China
- ClinicalTrials.gov ID
- NCT07143825
- Acronym / sponsor ID
- XH-25-006
- Conditions
- Preterm, Small Gestational Age (SGA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 27 Aug 2025 (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 goal of this nationwide multicenter observational study is to comprehensively investigate the severity of Small Vulnerable Newborns (SVN) issues across China and to propose further preventive and intervention measures. The primary aim is to provide a thorough description of SVN problems using a unified definition and framework, and to develop targeted prevention strategies.
Participating centers across the country will collect clinical data on vulnerable newborns under their care and complete detailed questionnaires to support this research.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Small vulnerable newborns admitted to major hospitals across various regions of China in 2024
Key inclusion criteria (5 listed)
- Newborns diagnosed as vulnerable infants at the participating hospitals between January 1 and December 31, 2024;
- Meeting any one of the following criteria:
Key exclusion criteria (1 listed)
- Incomplete medical records due to missing data preventing comprehensive case evaluation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of small vulnerable newborns
Time frame: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
Mortality rate
Time frame: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
1 secondary outcome
Incidence of complications in small vulnerable newborns
Time frame: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.
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 27 Aug 2025.
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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.
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 and Small Gestational Age (SGA), run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 27 Aug 2025. 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?
Contact Yongjun Zhang (+86-13651736760, zhangyongjun@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of small vulnerable newborns (time frame: From date of hospital admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 1 year.). The study lists 2 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 27 Aug 2025.