An observational study in Retinopathy of Prematurity (ROP), Bronchopulmonary Dysplasia (BPD) and Enterocolitis, Necrotizing, sponsored by Clinical Hospital Center Rijeka. Recruiting at 1 site in Croatia. Open to participants aged 6 Years to 7 Years. Per ClinicalTrials.gov, last updated 2026-10-22.
Sponsored by Clinical Hospital Center Rijeka · Observational
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:
Premature infants are the group that receives the most red blood cell transfusions. Between 50% and 90% of very low birth weight (VLBW) infants (less than 1500 g) and up to 95% of extremely low birth weight (ELBW) infants (less than 1000 g) will receive at least one red blood cell transfusion during hospitalisation.
To date, there are no clear guidelines for transfusion in premature infants in clinical practice.
Premature infants are particularly susceptible to tissue injury caused by impaired oxygen delivery, and complications are associated with this imbalance in tissue oxygenation. The pathophysiology of complications in transfused premature infants involves several interconnected mechanisms arising from organ immaturity and the specific effects of transfusion.
Over the past twenty years, numerous scientific studies have investigated the adverse effects of packed red blood cell transfusions. Many of these studies have associated red blood cell transfusions with a higher risk of both early and late complications of prematurity, such as necrotising enterocolitis (NEC), retinopathy of prematurity (ROP), bronchopulmonary dysplasia (BPD), intraventricular haemorrhage (IVH), and issues in later neurodevelopment. Only a few studies have reported beneficial effects of transfusion.
Red blood cell transfusion, along with other comorbidities in preterm infants, may contribute to neurological and neurodevelopmental damage. Some studies have confirmed that a restrictive approach leads to better neurodevelopmental outcomes, while others have shown abnormal brain structures and volumes at school age.
Based on previous research and the varied results obtained, the investigators aim to investigate the relationship between packed red blood cell transfusion, the number of transfusions, and the age at the time of transfusion concerning the occurrence of early and late prematurity complications. The investigators also seek to determine whether the haemoglobin level at the time of transfusion influences the development of complications. Although the impact on neurodevelopmental outcomes is partly understood and studied in younger premature children (aged 2 to 5), there are few studies and limited research on the effects in older children.
The hypothesis of this study is that premature infants who received packed red blood cell transfusions during the neonatal period have a higher rate of early prematurity complications and poorer neurological and neurodevelopmental outcomes at six years of age compared to premature infants who did not receive transfusions.
Investigation plan In the first, retrospective part, the investigators will collect epidemiological data from premature newborns (less then 32 weeks of gestation) from the hospital information system (IBIS) and the medical histories of the participants between June 2018 and December 2021.
The participants will be split into those who received a transfusion of packed red blood cells and those who did not.
In the second phase of the study, the investigators will evaluate the neurological and neurodevelopmental outcomes of the same participants during preschool age (at 6 years old adjusted for chronological age), based on the transfusion treatment. This phase will take place from September 2025 to December 2028. Parents of each child meeting the inclusion criteria will receive a notice about the study, which will be delivered by a primary care paediatrician during the examination that all children should have before starting their first year of primary school. After reading the notice, parents will sign the inform consent form if they agree to participate. The primary paediatrician will inform the main investigator, after which the child and parent or guardian will be invited to the Paediatrics Clinic for a neurological and neurodevelopmental assessment. Once all data collection is complete, statistical analysis will be performed to explore whether there is a connection between transfused preterm infants, early prematurity complications, and neurological and neurodevelopmental outcomes.
169 studies on the registry are indexed under Retinopathy of Prematurity; 27 are open to participants now.
This study's planned enrollment of 128 is below the median of 175 across 57 observational studies indexed under Retinopathy of Prematurity.
Browse Retinopathy of Prematurity studies →Clinical Hospital Center Rijeka is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
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The participants will be identified and selected by the primary care paediatricians in Primorsko-Goranska, Istarska, and Ličko-Senjska County (western part of Croatia)
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
All premature infants (less than 32 weeks of gestation) will be neurologically assessed at the age of six. Also, their neurodevelopmental outcome will be assessed at the age of six using the Wechsler Intelligence Test.
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.
Motor function at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
The outcome measure is the motor function of premature infants (less than 32 weeks of gestation) at the age of 6 years who received erythrocyte transfusion in the neonatal period. The aim is to identify the proportion of participants with normal, mildly impaired, moderately impaired, or severely impaired motor function. The Gross Motor Function Classification System (GMFCS) will be used to assess motor function. GMFCS is a standardized classification tool used to evaluate and describe motor function levels in children with cerebral palsy. It was created to offer a dependable framework for understanding restrictions in gross motor skills in children of different age groups. If The GMFCS score is 0, motor function is normal. Cerebral palsy will be classified as mild if the GMFCS score is 1, moderate if the GMFCS score is 2, and severe if the GMFCS score is 3 or higher. On the GMFCS scale, the minimum value is 0, and the maximum value is 5. The higher score means a worse outcome.
Time frame: From enrollment to the end of the neurologic assessment at 4 weeks.
Hearing assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
The aim is to identify the proportion of participants with normal and impaired hearing function. Hearing assessment depends on whether the child requires hearing aids. If the child needs hearing aids, the score will be 1; if not, the score will be 0. The minimum value is 0, and the maximum value is 1. A higher score means a worse outcome.
Time frame: From enrollment to the end of the hearing assessment at 4 weeks.
Visual assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
The aim is to identify the proportion of participants with normal and impaired visual function. Visual assessment depends on whether the child requires visual aids. If the child needs visual aids, the score will be 1; if not, the score will be 0. The minimum value is 0, and the maximum value is 1. A higher score means a worse outcome.
Time frame: From enrollment to the end of the hearing assessment at 4 weeks.
Neurodevelopmental outcome of premature infants who received erythrocyte transfusion compared to those who did not
Neurodevelopmental assessment will be conducted using the Wechsler Intelligence Scale for Children (WISC-IV). It is a clinical tool for evaluating the intelligence of children aged 6 to 16 years and 11 months. The test includes 15 subtests - 10 core and 5 supplementary. Intellectual functioning in specific cognitive areas is also represented by four composite scores: the Verbal Comprehension Index (VCI), the Perceptual Reasoning Index (PRI), the Working Memory Index (WMI), and the Information Processing Speed Index (PSI). The total test score (UIQ) is calculated based on the sum of scaled scores across the 10 core subtests. The resulting IQ scores are categorized as follows: 69 and below is extremely low; 70 to 79 is borderline; 80 to 89 is low average; 90 to 109 is average; 110 to 119 is high average; 120 to 129 is superior; and 130 and above is very superior. Minimum value is 40, and the maximum value is 200. The higher score means a better outcome.
Time frame: From enrollment to the end of the neurologic assessment at 4 weeks.
Plan to share: No — The ethics committee's initial decision was that the IPD would not be shared. However, the investigators may share the summarised and statistically processed data of the participants.
No publications or documents are linked to this record.
Started Sep 2025 (actual). Primary completion is estimated for Dec 2028, 39 months after the start.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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