跳至主要内容
临床试验/NCT06812507
NCT06812507招募中不适用

Evaluation of Placental Transfusion Techniques in of Prematurity Related Complications and Hematological Profile

Alexandria University1 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2025年3月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
160
试验地点
1
主要终点
Hemoglobin level

研究概览

简要总结

The objective of this study is to evaluate the general course and prognosis associated with different methods of placental transfusion (Intact umbilical cord milking, cut- umbilical cord milking and delayed cord clamping) in premature neonates over the first days of life

研究设计

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

入排标准

年龄范围
1 Minute 至 2 Minutes(Child)
性别
All
接受健康志愿者
是

入选标准

  • •Inclusion Criteria:
  • •Premature neonates ≤ 32 weeks gestational age regardless birth weight
  • •patients should be admitted to neonatal intensive care unit in the first day of life of life

排除标准

  • •Exclusion Criteria:
  • •Patient with any of the following will be excluded:
  • •Major congenital anomalies (complex cyanotic heart disease, major central nervous system anomalies).
  • •Evidence of head trauma causing major intracranial hemorrhage.
  • •placental abnormalities like : abruptions, placenta previa or retroplacental hematoma.
  • •Cord accident, or avulsion at the time of delivery.
  • •Refusal to perform the intervention by the obstetrician

研究组 & 干预措施

The procedure of Delayed Cord Clamping (DCC):

Experimental

Infants placed on the maternal abdomen or at the introitus below the level of placenta and waiting at least 30- to 60-second before clamping the cord.

干预措施: Delayed cord clamping (Procedure)

Control group:

No Intervention

patients will not receive any of the methods of placental transfusions

The procedure of intact umbilical cord milking (I-UCM)

Experimental

Umbilical cord milking will be performed by holding the newborn at or

∼20 cm below the level of the placenta. The cord will be pinched between 2 fingers as close to the placenta as possible and milked toward the infant over a 2-second duration. The cord will then be released and allowed to refill with blood for a brief 1- to 2-second pause between each milking motion. This will be repeated for 2-4 times. After completion, the cord will be clamped, and the neonate will be handed to the resuscitation team.

干预措施: intact umbilical milking (Procedure)

The procedure of Cut-umbilical cord milking(C-UCM):

Experimental

Another technique, used more often in Asia, involves clamping and cutting a long segment of the umbilical cord immediately at birth and passing the baby and the long cord to the pediatric provider, called C-UCM untwists the cord and milks the entire contents into the baby. Milking the cord 2-3 times before clamping may produce a similar placental transfusion as C-UCM

干预措施: cut umbilical milking (Procedure)

结局指标

主要结局

Hemoglobin level

时间窗: on admission (In first day after birth),as well as, at end of first , second and third weeks of lives

hemoglobin level will be measured in gram/dl

次要结局

未报告次要终点

研究者

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

Marwa Mohamed Farag

Assistant professor of Pediatrics

Alexandria University

研究点 (1)

Loading locations...

相似试验