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NCT Number: NCT07123948

The Correlation Between Red Cell Transfusion and Complications of Prematurity

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.

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Key information

Conditions

Retinopathy of Prematurity (ROP) Bronchopulmonary Dysplasia Bronchopulmonary Dysplasia (BPD) Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Enterocolitis Enterocolitis, Necrotizing Eye Diseases Female Urogenital Diseases and Pregnancy Complications Gastroenteritis Gastrointestinal Diseases Infant, Newborn, Diseases Infant, Premature, Diseases Intestinal Diseases Intraventricular Hemorrhage Neonatal Lung Diseases Lung Injury Mental Disorders Neurodevelopmental Disorders Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Respiratory Tract Diseases Retinal Diseases Retinopathy of Prematurity Urogenital Diseases Ventilator-Induced Lung Injury

Age range

6 year–7 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinical Hospital Centre Rijeka, Department of Paediatrics

Rijeka, Primorje-Gorski Kotar County, 51000, Croatia

Location contact

Kristina Lah Tomulić

CONTACT

[email protected]

+385992015885

Senada Šerifi, MD

CONTACT

[email protected]

Senada Šerifi, MD

PRINCIPAL_INVESTIGATOR

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • all children born as premature infants <32. weeks of gestation in Clinical Hospital Centre Rijeka from June 2018. to December 2021. (and who will be on September 2025. six years old)
  • signed informed consent

Exclusion criteria

  • genetic syndromes, severe congenital anomalies

Treatment and study plan

Wechsler Intelligence Test, performed by educated psychologists

Diagnostic Test

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.

Primary outcomes

  1. Motor function at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

    Time frame: From enrollment to the end of the neurologic assessment at 4 weeks.

    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.

  2. Hearing assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

    Time frame: From enrollment to the end of the hearing assessment at 4 weeks.

    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.

  3. Visual assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not

    Time frame: From enrollment to the end of the hearing assessment at 4 weeks.

    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.

  4. Neurodevelopmental outcome of premature infants who received erythrocyte transfusion compared to those who did not

    Time frame: From enrollment to the end of the neurologic assessment at 4 weeks.

    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.

Study contacts

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

Kristina Lah Tomulić

CONTACT

[email protected]

+385992015885

senada šerifi

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Clinical Hospital Center Rijeka

Other

Registry information

Official study title

The Correlation Between Packed Red Blood Cell Transfusion and Early and Late Complications of Prematurity

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Aug 14, 2025
Registry last updated
Aug 14, 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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