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NCT Number: NCT07143825

A National Multicenter Survey on Small Vulnerable Newborns

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.

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Key information

Conditions

Preterm Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Small Gestational Age (SGA) Urogenital Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

Yongjun Zhang

CONTACT

[email protected]

+86-13651736760

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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 outcomes

  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.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yongjun Zhang

CONTACT

[email protected]

+86-13651736760

Sponsors and collaborators

Lead sponsor

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Other

Registry information

Official study title

A National Multicenter Epidemiological Investigation of Small Vulnerable Newborns in China

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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