The Risk of Hyperbilirubinemia in Term Newborns After Placental Transfusion: A Randomized-blinded Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- The number of patients with hyperbilirubinemia requiring phototherapy or exchange transfusion.
研究概览
简要总结
Delayed cord clamping (DCC) has been a subject of extensive research for the last couple of years. Based on published data, numerous neonatal benefits have been suggested such as increased hemoglobin and ferritin levels both at birth and longer term. Available systematic reviews of DCC versus early cord clamping (ECC) reveal that it may also contribute to other neonatal outcomes including polycythemia and hyperbilirubinemia.
A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a second objective assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly.
In this randomized control study the investigators would like to determine if delayed cord clamping or cord milking during labor increases the risk of hyperbilirubinaemia (requiring phototherapy) in term infants.
详细描述
The investigators feel that published results regarding 'jaundice" and "jaundice needing phototherapy' (associated with DCC) may be misleading.
First, no information is offered about how "clinical jaundice "was assessed on examination. The absence of jaundice is not an indication of the absence of hyperbilirubinemia. Estimation of the degree of hyperbilirubinemia based solely on clinical examination can lead to errors. The absence or the severity of jaundice is not predictive of subsequent severe hyperbilirubinemia. A recent study revealed that the nurses' predischarge assessment of jaundice extent was only moderately correlated with bilirubin concentration and was similar in black and nonblack infants.
A review published nearly 10 years ago regarding late umbilical cord clamping revealed only 4 studies which as a secondary objective which assessed whether the time of cord clamping was associated with an increased risk of polycythemia and hyperbilirubinemia during the first week of life. Two studies reported that neonates with DCC had bilirubin levels >15 mg/dl. No information is provided on what hour of life the bilirubin levels were measured exactly.
Secondly, guidelines to treat jaundice have changed over time and none of the studies mention what threshold was used for administering phototherapy. No information is given if, staff responsible for phototherapy administration was blinded to the type of cord clamping intervention. Potential confounders such as isoimmune hemolytic disease, symptoms of sepsis (significant lethargy, temperature instability), asphyxia, G6PD, acidosis, albumin <3 g/L were not included in the analysis. Also another important factor such feeding policy at the time of bilirubin measurement wasn't mentioned in neither of the studies.
The presence of all mentioned above confounders in available studies has lead the investigators to conduct a blinded randomized trial.
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
- None
入排标准
- 年龄范围
- 37 Weeks 至 42 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All maternal-fetal dyads must comply with all of the following at randomization:
- •Term delivery between 37 -42 weeks of gestation (estimated by ultrasound).
- •Signed parental consent.
- •Singleton delivery.
- •Nonsmoking mothers.
- •Mothers willing to return for follow up visits.
- •Declaration of breastfeeding for at least six months.
排除标准
- •The following maternal - fetal dyads will be excluded
- •Preterm delivery < 37 weeks of gestation (estimated by ultrasound).
- •Isoimmune hemolytic disease.
- •Maternal Gilbert syndrome.
- •Birth asphyxia.
- •Serious maternal hemorrhage during delivery.
- •Major congenital abnormalities.
- •Need for early cord clamping (tight nuchal cord, need for resuscitation).
- •Participation in another trial.
结局指标
主要结局
The number of patients with hyperbilirubinemia requiring phototherapy or exchange transfusion.
时间窗: 14 days of life
Infants requiring phototherapy or exchange transfusion will be evaluated according to the AAP guidelines. The above evidence based guidelines describe the management of neonatal hyperbilirubinaemia in newborns above 35 weeks of gestation. Serum bilirubin levels will be interpreted according to the baby's age in hours. Physicians assessing the infant and prescribing phototherapy will be blinded to treatment.
次要结局
- The number of patients with polycythemia defined as a hematocrit > 65%.(48-72 hours of life.)
- The number of patients with symptomatic polycythemia (hematocrit > 75%), and non - symptomatic polycythemia (hematocrit >80%).(48-72 hours of life)
- The number of patients with symptomatic polycythemia defined as lethargy, plethora, jitteriness, tachycardia, tachypnea(48-72 hours of life)
- The number of patients with congenital anemia(at birth)
研究者
Joanna Seliga-Siwecka
Assistant
Princess Anna Mazowiecka Hospital, Warsaw, Poland