Physiological Versus One-Minute Based Delayed Cord Clamping Among Very and Moderate Preterm Infants Not Requiring Resuscitation: A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- delayed cord clamping (DCC)
研究概览
简要总结
We propose that the timing for clamping the umbilical cord should be individualized for each mother-infant pair rather than adhering to a fixed time frame. This is because placental transfusion continues until the placenta separates from the uterus. Therefore, the optimal time for delayed cord clamping (DCC) may be when the placenta has naturally separated, referred to as physiological-based cord clamping (PBCC). However, there is a lack of data comparing neonatal outcomes between delayed cord clamping and physiological-based cord clamping (defined as clamping after placental separation) in healthy very and moderately preterm infants. Many studies have assessed outcomes such as infant hemoglobin levels, iron status, ferritin levels, jaundice, need for phototherapy, necrotizing enterocolitis, and intraventricular hemorrhage in preterm infants, comparing early and delayed cord clamping. Nonetheless, there are limited studies that specifically compare these outcomes between delayed and physiological cord clamping in preterm births.
**Population-**Very and moderate preterm (28+0-33+6) infants not requiring resuscitation
**Intervention-**Clamping the cord after separation of the placenta (Caesarean section:Placental separation is noted by gush of the blood and placenta coming out of the incision; Vaginal delivery: Placental separation is noted when the placenta has descended into the vagina with gush of blood and lengthening of the cord)
**Control-**Clamping cord at 60 seconds
**Outcome-**90% preductal oxygen saturation (SpO2)
**Time-**Time till 90% preductal oxygen saturation (SpO2) is attained
Research Question- What is the time to reach 90% preductal oxygen saturation (SpO2) among very and moderate preterm infants (28+0**-33+6**weeks) who do not require resuscitation, and underwent physiological-based cord clamping (PBCC) compared to one-minute based delayed cord clamping (DCC)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 0.00 Day(s) 至 4.00 Month(s)（—）
- 性别
- All
入选标准
- •Very and moderate preterm (28+0–33+6 weeks) singleton pregnancy or multifetal gestation (only dizygotic pregnancy) with anticipated delivery irrespective of the mode of delivery, i.e., vaginal and LSCS, either elective or emergency.
- •(Gestational age will be assessed by last menstrual period [LMP] or early dating scan if LMP is not available.).
排除标准
- •Multifetal gestation (Other than Dizygotic pregnancy)
- •Suspected or confirmed congenital anomaly or syndrome in the fetus
- •Neonates with major congenital malformation or having syndromic appearance noted at birth
- •Neonates requiring resuscitation immediately after birth.
- •Neonates where PBCC could not be practiced due to any maternal or neonatal reason.
结局指标
主要结局
delayed cord clamping (DCC)
时间窗: Time taken to reach 90% preductal oxygen saturation
To study the time to reach 90% preductal oxygen saturation (SpO2) among very and moderate preterm infants (28+0-33+6weeks) who do not require resuscitation and underwent physiological-based cord clamping (PBCC) compared to one-minute-based
时间窗: Time taken to reach 90% preductal oxygen saturation
次要结局
- Maternal Postpartum haemorrhage(Within 24 hours after birth)
- To compare heart rate, saturation till 10 minutes of life and Expanded Apgar score at 1, 5, and 10 minutes of life.(Till 10 minutes of life)
- To study difference in hematocrit levels at 24(±4) hours among very and moderate preterm infants (28+0-33+6 weeks).(24(±4) hours)
- Incidence of respiratory distress, need of CPAP alone, mechanical ventilation, and fluid bolus or inotropic support in the first 48 hours of life.(First 48 hours of life)
- Incidence of polycythemia and jaundice requiring treatment with phototherapy or exchange transfusion, or both till discharge, need of blood transfusion during hospital stay(Till discharge of patient)
- To compare the hematological parameters like hemoglobin, MCV, MCHC, Reticulocyte count and Peripheral smear at 4 (±1) weeks of life.(4(±1) weeks of life)
- To compare incidence of neonatal in-hospital morbidities like IVH (any grade and severe IVH), NEC (any stage and definite NEC), PVL, BPD, PDA requiring treatment, Sepsis (Culture negative and culture positive, early onset and late onset), ROP (any stage), and ROP requiring treatment.(Till Discharge of patient)
- To compare in-hospital mortality among both groups.(Till In-hospital stay)
- Maternal in-hospital mortality, need of blood transfusion and ICU admission post-delivery till discharge(Till Discharge)
研究者
Dr Neeraj Gupta
All India Institute of Medical Sciences, Jodhpur