MDW as a new marker for late-onset sepsis in preterm newborns

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 observational study evaluates MDW as a potential biomarker to diagnose late-onset neonatal sepsis in preterm neonates and to explore its relationship with disease severity and short-term outcomes. Blood samples will be assessed for MDW alongside standard clinical assessments when infection is suspected. The goal is to determine if MDW improves early detection and informs clinical management in this high-risk population.

Why it matters

Who can join: the full rules

Inclusion Criteria:The study will include:

1. Preterm neonates with gestational age \<37 weeks.
2. Neonates aged \>72 hours of life at the time of enrollment.
3. Neonates with clinical suspicion of late-onset neonatal sepsis, defined by the presence of one or more of the following:

   * Temperature instability (core temperature \>38°C or \<36°C)
   * Respiratory distress or new-onset apnea
   * Feeding intolerance or poor feeding
   * Lethargy or irritability
   * Bradycardia or tachycardia
   * Hypotension
   * Unexplained clinical deterioration

Exclusion Criteria:

* Neonates with any of the following will be excluded from the study:

  1. Early onset neonatal sepsis.
  2. Major congenital anomalies
  3. Chromosomal abnormalities
  4. Metabolic disorders
  5. Severe perinatal asphyxia
  6. Neonates with surgical conditions

Where it's running

• Faculty of Medicine, Tanta University
  Tanta, Egypt Recruiting

Study contacts

• Study coordinator: Lamiaa Khaled Zidan
• Email: lamia.kh.z@gmail.com
• Phone: 00201007958439

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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.