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临床试验/NCT01666847
NCT01666847已完成不适用

Milking the Umbilical Cord for Extreme Preterm Infants

St. Louis University4 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2012年10月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
4
主要终点
To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping

研究概览

简要总结

Milking the umbilical cord from the placental end toward the infant has been shown to benefit preterm infants when compared to either clamping the umbilical cord immediately or waiting delaying the clamping of the cord. Delaying cord clamping for 30-120 seconds has been shown to improve heart and lung function, reduces the need for blood transfusion, and reduces the risk for brain bleeding seen in some preterm infants. Delaying the clamping of the umbilical cord, however in extremely premature infants is not considered safe, since it also delays the resuscitation that these infants need immediately after birth. Milking the umbilical cord is believed have similar benefits to delaying the clamping of the cord, but can be done much faster (seconds rather than minutes). In this study, the cord will milked three times over about 10-20 seconds and the infant will be passed to the awaiting newborn medical team for routine care. Participants of this study will be randomly assigned to one of two study groups: the first group will have the cord milking intervention and the second group will not have any intervention other than routine, immediate cord clamping with routine care of mother and infant. Data will be collected about the mother prior to delivery and data will also be collected about the baby using computerized health records. The data will look at short term changes in red blood cell volumes, the need for blood transfusions, and rates of known complications of prematurity, including longer term developmental complications at 18-24 months.

The hypothesis is that milking the umbilical cord before cutting the cord will lead to a higher hemoglobin concentration and decrease the need for blood transfusions in extremely preterm neonates compared to the current standard of immediately clamping the umbilical cord.

详细描述

Eligible infants include singleton infants born between 24 and 27 6/7 weeks gestation who do not have congenital anomalies.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • pregnant women/child pairs with infants born at an estimated gestation age between 24 0/7 and 27 6/7 weeks based on best estimate made by last menstrual period or ultrasound
  • informed consent obtained by the pregnant women prior to delivery of the infant.

排除标准

  • pregnancy with a multiple gestation
  • infants with pre- or postnatally diagnosed major congenital anomalies or probable chromosomal abnormalities
  • infants with hydrops fetalis

研究组 & 干预措施

Cord Milking

Experimental

Infant receiving cord milking intervention before umbilical cord clamped.

干预措施: Milking the umbilical cord before cord clamping (Procedure)

Immediate Cord Clamping

No Intervention

Infant whose umbilical cord is immediately clamped after delivery.

结局指标

主要结局

To evaluate and compare hemoglobin and hematocrit concentrations in extremely low birth weight infants (ELVW) after cord milking intervention to ELBW infants receiving immediate cord clamping

时间窗: Within 4 hour of birth

To evaluate and compare the incidence and numbers of blood transfusions after cord milking

时间窗: Prior to initial infant discharge

次要结局

  • To evaluate long term outcomes of prematurity in both groups in a follow-up study(Until 3 years corrected gestational age)
  • To compare the difference in hemoglobin and hematocrit from umbilical cord blood(Within 4 hours of birth)
  • To evaluate and compare blood pressure after intervention and need for support medications(For first seven days of life)
  • To evaluate and compare the incidence of hyperbilirubinemia and length of phototherapy(Three weeks)
  • To evaluate the incidence of complications of prematurity in the study and control groups(Until 3 years corrected gestational age)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Justin Josephsen M.D.

Assistant Professor

St. Louis University

研究点 (4)

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