Early warning system for neonatal NEC to help predict risk in very preterm babies

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multicenter observational study develops and tests a prediction model for necrotizing enterocolitis (NEC) in preterm infants. It uses retrospective data and prospective validation across three hospitals to see if genetic susceptibility and longitudinal immune/inflammatory markers add value beyond clinical factors. The development phase leverages an existing exome sequencing cohort, with internal and temporal validations, followed by geographic external validation and a future prospective cohort. The study does not involve an intervention; it aims to improve early risk prediction to support clinical decision-making. Records from the same infant are kept in a single cohort to avoid overlap, with careful checks for duplicates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Birth before 32 completed weeks of gestation.
* Admission to the neonatal department of one of the three participating hospitals.
* Availability of perinatal and hospitalization information required by the approved cohort-specific data collection plan.
* For the development cohort, clinical exome sequencing performed during the neonatal hospitalization.
* For retrospective validation cohorts, available clinical records and extractable longitudinal complete blood count data.
* For the prospective cohort, written permission from a parent or legally authorized guardian for participation and for the use of residual blood for genetic analysis as required by the approved protocol.

Exclusion Criteria:

* Congenital malformations, a defined clinical syndrome, or a chromosomal abnormality meeting the exclusion definition in the approved protocol.
* Death or discharge against medical advice within the first 7 days after birth.
* A confirmed pathogenic genetic diagnosis that explains the main clinical phenotype.
* An additional infant from the same monozygotic multiple birth when one infant from that pregnancy has already been selected for analysis according to the prespecified selection rule.

Where it's running

• Maternal and Child Health Hospital of Guangxi Zhuang Autonomous Region.
  Guangxi, Guangxi, China Recruiting
• Northwest Women's and Children's Hospital
  Xi’an, Shanxi, China Recruiting

Study contacts

• Study coordinator: Liyuan Hu, Ph.D.
• Email: nowadays921@126.com
• Phone: +86-13816060888

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.