Delayed cord clamping for 1 minute versus 2-3 minutes in preterm neonates, a double blinded randomised controlled trial.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 264
- 试验地点
- 1
- 主要终点
- Neurological outcome at 1 year of age.
研究概览
简要总结
Delayed cord clamping (DCC)which is umbilical cord clamping done after 30-60 seconds of birth is currently practised as a standard of care in all term infants and stable preterm infants. In term infants, DCC increases haemoglobin levels and improve iron stores in the first several months of life. In preterm infants, DCC improves transitional circulation, increases red blood cell volume, decreases the need for blood transfusion, lowers necrotizing enterocolitis and intraventricular haemorrhage. However, the optimal timing of umbilical cord clamping in preterm infants is unclear. There is a concern of DCC causing polycythemia and neonatal jaundice in preterm infants. A brief delay in cord clamping in preterm infants has shown to stabilize circulation, decreases fluid bolus and inotropic requirement as well. DCC has shown to improve long term neurological and developmental outcomes.
Various guidelines recommend DCC for more than 30 seconds, 30 to 60 sec, atleast 60 seconds, 30 to 180 minutes in stable preterm infants.
A recent network meta-analysis has compared different timings of DCC in preterm infants and have emphasised the need for prolonged DCC. They have recommended further trials to confirm the benefits.
Given that DCC is beneficial for over all outcomes in preterm infants and there is no study till date comparing 1 min vs 2 to 3 minute DCC, we aimed to compare the same. The primary outcome will be abnormal neurodevelopmental outcome at 1 year of age. Other outcomes such as mortality, IVH, PVL, NEC, ROP, duration of mechanical ventilation, phototherapy, need for inotropes, PDA, NICU stay duration, sepsis, BPD, hematocrit at 6 hours and 6 weeks will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 1.00 Day(s)（—）
- 性别
- All
入选标准
- •All preterm babies less than 37 weeks gestational age.
排除标准
- •Non vigorous baby.
- •Prenatally diagnosed major congenital anomaly.
- •Intrauterine fetal death.
- •In utero transfusion/laser/amnioreduction.
- •Antepartum Haemorrhage.
- •Active maternal bleeding from abruption/placental disruption at time of delivery, cord tear/avulsion.
结局指标
主要结局
Neurological outcome at 1 year of age.
时间窗: 12months
次要结局
- Mortality(28 days and 1 year)
- Severe intraventricular haemorrhage.(28 days)
- Periventricular Leukomalacia(28 days and 1 year)
- Retinopathy of prematurity.(21 days,28 days)
- Necrotising Enterocolitis.(28days)
- Respiratory distress syndrome(2 days)
- Duration of mechanical ventilation in days.(28 days)
- Bronchopulmonary dysplasia.(28 days)
- Haemodynamically significant Patent Ductus Arteriosus requring treatment.(7 days)
- Polycythemia(At 6 hours, 6 weeks after birth)
- Duration of phototherapy.(28 days)
- Number of blood transfusions required.(28 days)
- Highest total bilirubin.(28 days)
- Need for inotropes.(1 day, 7 days,28 days)
- length of NICU stay(28 days)
研究者
Dr Anitha Ananthan
Seth GS Medical College and KEM hospital