Comparison of effects of three umbilical cord management strategies on mean haemoglobin levels and other neonatal outcomes: A Single Centre Randomised Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM)
研究概览
简要总结
This is a single centre randomised controlled trial including newborn from day 0 to 3 months of age to see how the outcome changes depending on the cord clamp management. Singleton babies delivered at 32(0/7) to 41(6/7) weeks gestation, from uncomplicated pregnancy, vigorous at birth divided into three groups ,25 babies in each group, total 75 babies. Three groups are 1. early cord clamping without milking, 2. delayed cord clamping with milking, 3. delayed cord clamping without milking. Exclusion criteria being newborn requiring resuscitation, congenital anomalies, IUGR, multiple gestation, placental anomalies, alloimmunisation, foetal hydrops. Primary outcome would be mean haemoglobin at 72 hours of life. Other outcome would be frequency of IVH, NEC, hyperbilirubinemia, need for phototherapy, NICU admission, shock, mechanical ventilation and duration of stay in the hospital.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 5.00 Day(s)（—）
- 性别
- All
入选标准
- •Singleton vigorous newborns born at 32 (0/7) to 41 (6/7) weeks of gestation from largely uncomplicated pregnancies.
排除标准
- •newborns requiring resuscitation, multiple gestations, congenital anomalies, placental abnormalities, alloimmunization, foetal hydrops, fetal compromise, and maternal illness affecting foetal well-being.
结局指标
主要结局
Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM)
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life.
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Frequency of IVH
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Frequency of NEC
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Frequency of neonatal hyperbilirubinemia
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Incidence of phototherapy
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Length of stay after birth.
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
时间窗: Primary outcome: To compare the mean haemoglobin levels at 72 hours of birth during routine blood tests amongst 3 study groups: 1. DCC, 2. ECC without milking (ECC - CM) & 3. ECC with milking (ECC + CM) | Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life. | Frequency of IVH | Frequency of NEC | Frequency of neonatal hyperbilirubinemia | Incidence of phototherapy | Length of stay after birth. | Other adverse outcomes; cardiac decompensation & shock, NICU admission, mechanical ventilation
次要结局
- Secondary outcome: To compare following outcomes amongst 3 study groups within first 3 months of life.(Frequency of IVH)
研究者
Pooja Anthwal
Jagannath Gupta Institute of Medical Sciences