A National Multicenter Survey on Small Vulnerable Newborns

August 19, 2025 updated by: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Small vulnerable newborns admitted to major hospitals across various regions of China in 2024

Description

Inclusion Criteria:

  1. Newborns diagnosed as vulnerable infants at the participating hospitals between January 1 and December 31, 2024;

  2. 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.

Exclusion Criteria:

  • Incomplete medical records due to missing data preventing comprehensive case evaluation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
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.
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2025

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2026

Study Registration Dates

First Submitted

August 12, 2025

First Submitted That Met QC Criteria

August 19, 2025

First Posted (Estimated)

August 27, 2025

Study Record Updates

Last Update Posted (Estimated)

August 27, 2025

Last Update Submitted That Met QC Criteria

August 19, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XH-25-006

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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