The Correlation Between Packed Red Blood Cell Transfusion and Early and Late Complications of Prematurity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Motor function at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 6 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •all children born as premature infants <
- •weeks of gestation in Clinical Hospital Centre Rijeka from June
- •to December
- •(and who will be on September
- •six years old)
- •signed informed consent
排除标准
- •genetic syndromes, severe congenital anomalies
结局指标
主要结局
Motor function at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
时间窗: 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.
Hearing assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
时间窗: 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.
Visual assessment at the age of 6 years in premature infants who received erythrocyte transfusion compared to those who did not
时间窗: 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.
Neurodevelopmental outcome of premature infants who received erythrocyte transfusion compared to those who did not
时间窗: 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.
次要结局
未报告次要终点
研究者
Kristina Lah Tomulić
assoc. professor
Clinical Hospital Center Rijeka