A National Multicenter Survey on Small Vulnerable Newborns

NCT07143825 | Recruiting

• 1 other identifier: XH-25-006
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (2)

• Number of small vulnerable newborns

  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

  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

  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.

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Premature Birth

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Central Study Contacts

Yongjun Zhang

CONTACT

+86-13651736760; zhangyongjun@sjtu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2025
• First Posted: August 27, 2025
• Study Start: April 1, 2025
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 27, 2025

Record last verified: 2025-08

Locations

CN (1)