Role of Umbilical Cord Milking in the Management of Hypoxic-ischemic Encephalopathy in Neonates: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Incidence and severity of HIE in depressed neonates with and without umbilical cord milking
研究概览
简要总结
The purpose of this study is to investigate the efficacy and safety of umbilical cord milking in depressed neonates at birth for prevention of hypoxic ischemic encephalopathy.
详细描述
Hypoxic-ischemic encephalopathy (HIE) is a brain injury caused by inadequate supply of oxygen and blood to the brain of a newborn baby. Therapeutic hypothermia is the only proven therapy for these infants. Even after receiving therapeutic hypothermia, 50% of all infants with moderate and severe HIE die or develop neurological and functional impairment. There is a need for a new intervention for neonatal HIE, which is readily available in developing countries and can complement hypothermia.
The American College of Obstetricians and Gynecologists and American Academy of Pediatrics recommend a delay in umbilical cord clamping in vigorous term and preterm infants for at least 30-60 seconds after birth. Immediate umbilical cord clamping is contraindicated in maternal hemodynamic instability, need for immediate resuscitation of the newborn and in conditions where placental circulation is not intact. Umbilical cord milking (UCM) is a simple method of delivering volume and possibly stem cells to those neonates, where resuscitation cannot be postponed for obtaining the benefits of delayed cord clamping.
We hypothesize that depressed neonates who receive umbilical cord milking will have lower incidence and severity of hypoxic ischemic encephalopathy compared to depressed neonates who receive immediate cord clamping.We propose to investigate the safety and effectiveness of UCM in term and late preterm (≥35 week's gestation) infants who are depressed at birth, in preventing the development and/or progression of hypoxic ischemic encephalopathy. The need for immediate resuscitation measures, abnormal parameters (clinical, hematological and biochemical) and neuroimaging will be compared in depressed neonates with and without UCM. If UCM is found to be safe and beneficial, it can be a useful substitute for delayed cord clamping in depressed neonates worldwide.
Conditions: Depressed neonate, Hypoxic-ischemic encephalopathy Intervention: Umbilical cord milking
Study Design Study Type: Interventional Study Design: Allocation: Randomized Endpoint Classification: Efficacy/Safety Study Intervention Model: Parallel Assignment Number of Arms: 2 Masking: Single Blind (Subject) Primary Purpose: Prevention Enrollment: 400 [Anticipated]
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)
盲法说明
Single Blind (Subject)
入排标准
- 年龄范围
- 1 Minute 至 24 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Neonates of ≥35 week's gestation and born depressed (defined by NRP 2015 criteria: as those neonates who doesn't cry or breathe at birth and whose tone is poor) in the hospital
排除标准
- •MCDA Twin pregnancy (DCDA twins are included)
- •Triplet or quadruplet pregnancy
- •Presence of IUGR in antenatal scans (< 10th Centile)
- •Short umbilical cord length (<30 cm)
- •Rh-negative or retrovirus positive mothers
- •Major chromosomal or congenital anomalies
- •Hydrops fetalis
- •Severe placental abruption
- •Cord prolapse and cord abnormalities such as true knots
- •Culture positive early onset neonatal sepsis
结局指标
主要结局
Incidence and severity of HIE in depressed neonates with and without umbilical cord milking
时间窗: 72 hours
The severity of HIE if any will be assessed by modified Sarnat staging which is based on level of consciousness, spontaneous activity, neuromuscular control, primitive reflexes, autonomic function and seizures. \[Designated as safety issue: No\]; Ref:Sarnat HB, Sarnat MS. Neonatal encephalopathy following fetal distress. A clinical and electroencephalographic study. Arch Neurol. 1976; 33:696-705. PMID: 987769
次要结局
- The number of neonates with symptomatic polycythemia(48 hours after birth)
- The number of neonates with hyperbilirubinemia requiring phototherapy or exchange transfusion.(72 hours after birth)
- MRI changes in the brain of neonates with moderate and severe degrees of HIE who underwent whole body hypothermia.(14 days after birth)
- Haemoglobin levels at 6 weeks of age(6 weeks after birth)
- The resuscitation interventions required and the short term outcomes for depressed newborns with and without umbilical cord milking.(20 minutes after delivery)
- Blood lactate at 24 hours(1st 24 hours after delivery)
- The number of neonates with anemia(2 hours after birth)
- CD34+ stem cell count at 24 hours(24 hours after birth)
- Requirement of Neonatal Intensive Care Unit (NICU) admission(1st 24 hours after delivery)
- Survival at 6 weeks of age(6 weeks after birth)
- Serum ferritin levels at 6 weeks of age(6 weeks after birth)
- Duration of hospital stay in neonates with any grade of HIE.(Duration of hospital stay, an expected average of 7-14 days)
研究者
Dr. Manoj Varanattu
Professor, Department of Neonatology
Jubilee Mission Medical College and Research Institute