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Recruiting NCT07143825

A National Multicenter Survey on Small Vulnerable Newborns

Observational Preterm Small Gestational Age (SGA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Preterm, Small Gestational Age (SGA). Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China

Overview

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.

Primary outcome measures

  • 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.]
Secondary outcome measures (1)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Case-only

Study locations

China · 1 center
  • Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine — Shanghai

Identifiers

NCT: NCT07143825 · XH-25-006

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗