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The Correlation Between Red Cell Transfusion and Complications of Prematurity

NCT07123948 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 128

Last updated 2025-08-14

No results posted yet for this study

Summary

The aim of this clinical trial is to learn if there is a correlation between the erythrocyte transfusion in the early neonatal period in premature infants and early and late complications of prematurity. The main questions it aims to answer are:

* Do premature infants who receive blood transfusions within their first month of life have a higher risk of early prematurity complications, such as retinopathy of prematurity, necrotising enterocolitis, bronchopulmonary dysplasia, and intraventricular haemorrhage?
* Do premature infants who receive blood transfusions during their first month of life have worse neurological and neurodevelopmental outcomes than those who do not? The first part of the study is retrospective, using data collected from participants' histories. The second part is prospective, evaluating neurological and neurodevelopmental outcomes at the age of six years.

Conditions

  • Retinopathy of Prematurity (ROP)
  • Bronchopulmonary Dysplasia (BPD)
  • Enterocolitis, Necrotizing
  • Intraventricular Hemorrhage Neonatal

Interventions

DIAGNOSTIC_TEST

Wechsler Intelligence Test, performed by educated psychologists

At the age of six, parents of children who meet the inclusion criteria will receive a notification about the study from the responsible paediatrician. If they agree to participate, they will sign an informed consent form. They will then be invited to the clinic for a neurological and neurodevelopmental assessment. The neurological examination will be conducted by the principal investigator or collaborators who are paediatric specialists. The neurodevelopmental evaluation will be performed by a qualified psychologist using the Wechsler Intelligence Test. The Wechsler Intelligence Test for Children - Fourth Edition is a clinical tool for measuring the intelligence of children aged 6 to 16 years and 11 months. It assists in identifying specific learning difficulties, hyperactivity disorder, speech and language challenges, and intellectual impairments. The test comprises 15 subtests.

Sponsors & Collaborators

  • Clinical Hospital Center Rijeka

    lead OTHER

Principal Investigators

  • senada šerifi · Clinical Hospital Centre Rijeka, Croatia

Eligibility

Min Age
6 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-09-01
Primary Completion
2028-12-31
Completion
2029-03-01

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07123948 on ClinicalTrials.gov