Evaluating role of human cord blood CD34+ cells as a novel biomarker in perinatal asphyxia: A prospective case-control study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 42
- 试验地点
- 1
研究概览
简要总结
Neonatal hypoxic-ischemic encephalopathy (HIE) is a leading cause of neonatal morbidity and mortality, often resulting in long-term neurodevelopmental impairments. Early identification of HIE severity is important for timely intervention. CD34-positive (CD34+) hematopoietic stem cells, known for their regenerative and neuroprotective properties, may serve as a reliable novel biomarker for predicting HIE severity and outcomes as shown in recent study.
Objective: To evaluate the association between CD34+ cell levels in umbilical cord blood and the severity of HIE in term neonates. Secondary objectives include exploring correlations between CD34+ levels, clinical parameters (e.g., APGAR scores, cord pH), haematological markers (e.g., NRBC, TLC), and adverse outcomes such as mortality and neurodevelopmental impairment.
Methods: This case-control study will enroll term neonates with perinatal asphyxia who have HIE as cases and healthy term neonates without perinatal asphyxia as controls. Umbilical cord blood will be collected at birth to measure CD34+ levels using flow cytometry. Data on clinical parameters, laboratory markers, and outcomes will be analyzed. Statistical methods will include t-tests, ANOVA, correlation analysis, and logistic regression to determine the association between CD34+ levels and HIE severity and outcomes. CD34+ cell levels could provide a novel early biomarker for assessing HIE severity and predicting adverse outcomes, potentially guiding therapeutic decisions and improving neonatal care.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •37 week and 0 day to 42week and 6 days gestational age and more than 1.8kgs
- •Evidence of asphyxia as defined by the presence of at least two of the following four criteria: A.
- •Apgar less than 5 at 10 minutes or continued need for resuscitation with positive pressure ventilation with or without chest compressions at 10 minutes of age B.
- •Any acute perinatal event that may result in HIE (abruption placenta, cord prolapse, severe foetal heart rate abnormality.).
- •Cord pH less than 7.1 or base deficit of 12 or more within 60 minutes of birth D.
- •If cord pH is not available, arterial/ capillary/ venous pH less than 7.1 or BE more than 12 mmol/L within 60 minutes of birth
- •Clinical signs of HIE
- •aEEG suggestive of HIE 2.Controls: 1.37 week and 0 day to 42week and 6 day gestational age and more than 1.8kgs
- •Apgar score more than 7 at 5 minutes.
排除标准
- •Cases: 1.Neonates with congenital anomalies or chromosomal abnormalities.
- •2.Neonates from multiple pregnancies.
- •3.Parents not giving consent for participation.
- •Controls 1.Neonates with congenital anomalies or chromosomal abnormalities.
- •3.Maternal infections/ chorioamnionitis at the time of birth.
- •4.Presence of fetal distress.
- •5.Maternal gestational diabetes mellitus, hypertension.
研究者
Dr Nishant Banait
All India Institute of Medical Sciences Nagpur