The Study on Umbilical Cord Milking to Prevent and Decrease the Severity of Anemia in preterms--a Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- concentrations of Hematocrit(Hct)
研究概览
简要总结
The overall objective of the present study is to examine the effects of umbilical cord milking at birth in preterm infants to prevent and decrease anemia using a multi-center prospective randomized controlled trial comparing immediate cord clamping (standard at present) with umbilical cord milking.
详细描述
Anemia is a significant problem for pre-term infants and a major risk factor for preterm babies mortality and morbidity in neonatal intensive care unit(NICU). the majority of pre-term babies will require one or more blood transfusions during in NICU. Blood transfusion is a safe procedure but like all therapeutic interventions has risks associated with it and effort is made to reduce the number of transfusions that infants require during their stay on the neonatal unit.
Delayed cord clamping has a beneficial effect on prevention of anemia in later infancy because of increased iron stores at birth. However there are controversies in incorporating delayed cord clamping practice in the management of third stage of labour globally. Concerning about the need for urgent resuscitation and temperature management, attendants encouraged to clamp the umbilical cord immediately so that post-natal resuscitation and care can start as soon as possible.However,umbilical cord milking allows for swift intervention and resuscitation and attention to thermal care and should take less than 10 seconds to complete.
The specific aim of this study is to investigate the effects of umbilical cord milking on preventing and decreasing anemia in very pre-term infants.
Primary Outcomes:
Hemoglobin (Hb), Hematocrit (Hct) and serum iron levels at birth, at 1 week,at 2 weeks of age.
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
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women in labour or with a plan for delivery at a gestational age less than 34 weeks gestation.
- •Singleton pregnancy
- •informed consent was obtained from the parent
排除标准
- •Multiple gestation
- •Diagnosis of any of the following in the current pregnancy: hemorrhage requiring clinic/hospital admission, placental abnormalities, fetal anomalies, Down's syndrome of the fetus,anemia
- •Diagnosis of pre-eclampsia or eclampsia in current or previous pregnancies
- •Diagnosis at any time for the mother of any of the following: serious Diabetes, serious hypertension, chronic renal disease
- •Infant with major congenital malformation
- •Infant with blood disease
- •Unwilling to return for follow-up study visits at the hospital
研究组 & 干预措施
umbilical cord milking
preterm baby were placed at or below level of the placenta and about 25cm of the umbilical cord was vigorously milked towards the umbilicus two to three times before clamping the cord. The milking speed was about 25cm/2 seconds
干预措施: umbilical cord milking (Procedure)
umbilical cord clamping immediately
Umbilical cord was clamped immediately, or as close as possible, after delivery of the infant's shoulders. (This was standard practice in the study hospital, thus it served as the "control" group).
干预措施: umbilical cord clamping immediately (Procedure)
结局指标
主要结局
concentrations of Hematocrit(Hct)
时间窗: 48 hours after birth
concentrations of Hemoglobin (Hb)
时间窗: 48 hours after birth
serum ferritin level
时间窗: 48 hours after birth
次要结局
- Hyperbilirubinemia requiring phototherapy(during first 2 weeks of age)
- incidence and numbers of blood transfusions(until 3 months corrected gestational age)
- complication(Birth to discharge, expected average of 30 days)
- Length of admission(Birth to discharge, expected average of 30 days)
研究者
Lijuan Xie
Principal Investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine