Modified Diagnosis and Treatment of Neonatal Hemolysis Incorporated With ETCOc Measurement in Severe Neonatal Hyperbilirubinemia Management
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- neural damage confirmed by professional assessments such as Bayley Scales
研究概览
简要总结
The goal of this clinical trial is to learn if modified diagnosis and treatment (MDT) of neonatal hemolysis (a common cause to newborn jaundice) incorporated with ETCOc measurement (a non-invasive measurement of exhaled gas) works to prevent brain damage in newborns with severe hyperbilirubinemia (sNH). It will also learn about the. occurrence of cranial MRI in the study participants. The main questions it aims to answer are:
- Does MDT lower the possibilities participants have brain damage before the age of one?
- How many times of abnormalities in cranial MRI is detected before the age of one? Researchers will compare MDT to a control (a current management) to see if MDT works to prevent brain damage in newborns with sHN.
Participants will:
- Take MDT or a control method in the management of sNH
- Assess if there's brain damage before discharge and at the year of one
- Record how many times of abnormalities in cranial MRI is detected before the age of one
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 4 Hours 至 28 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion Criteria:
- •Infants with gestational age of 35(+0) to 41(+6) weeks and birth weight ≥ 2500 grams
- •Infants with severe neonatal hyperbilirubinemia, including those whose serum total
- •bilirubin (TSB) levels reach above 20 mg/dL or whose TSB levels at any time reach within 2 mg/dL of the exchange transfusion threshold (i.e., TSB > (threshold - 2) mg/dL).
排除标准
- •Infants with definite congenital genetic metabolic diseases, chromosomal or genetic disorders, or severe malformations.
研究组 & 干预措施
study
modified diagnosis and treatment (MDT) for neonatal hemolysis
干预措施: MDT (Combination Product)
control
Control (current) method for sNH (severe neonatal hemolysis) with the description as follow：
- Diagnosis of neonatal hemolysis： The neonatal subjects with symptom of hyperbilirubinemia are diagnosed as hemolysis if they have positive Direct Antiglobulin Test (DAT) or positive release test result.
- Exchange transfusion (ET) therapy for sNH： The neonatal subjects with symptom of hyperbilirubinemia are treated with ET therapy if their Total serum bilirubin (TSB) reaches or exceeds the current exchange transfusion threshold;
干预措施: control (current management) (Other)
结局指标
主要结局
neural damage confirmed by professional assessments such as Bayley Scales
时间窗: at the age of 12 months
Neurological impairment, including any of the following: diagnosis of cerebral palsy, diagnostic hearing tests indicating hearing impairment, or a score lower than 85 on the Bayley Scales Neurobehavioral Assessment. Bayley Scales means Bayley Scales of Infant and Toddler Development and it can assess the neural development of infants including Cognitive, Language (Receptive/Expressive), Motor (Fine/Gross), Social-Emotional, and Adaptive Behavior. Standard scores for each domain range from 40 to 160 (mean = 100; SD = 15). Higher scores indicate better developmental outcomes, while lower scores suggest potential delays. For example, a cognitive score of 115 reflects performance above the average range, whereas a score of 85 falls below the average range.
次要结局
未报告次要终点