A National Multicenter Survey on Small Vulnerable Newborns

A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07143825

Enrollment

2000

Registered

2025-08-27

Start date

2025-04-01

Completion date

2026-12-31

Last updated

2025-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Preterm, Small Gestational Age (SGA)

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame	Description
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.	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.

Countries

China

Contacts

Primary ContactYongjun Zhang

zhangyongjun@sjtu.edu.cn+86-13651736760

Outcome results