Effects of Delayed Cord Clamping in Very Low Birth Weight (VLBW) Infants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped
研究概览
简要总结
The purpose of this study was to see if a brief delay in cord clamping for 30 to 45 seconds would result in higher hematocrit levels, fewer transfusions, healthier lungs, and better motor function at 40 wks and 7 months of age.
详细描述
When cord clamping is delayed at birth or the cord is milked, infants receive a placental transfusion of 10-15 mL/kg during the first few minutes of life. This additional blood improves hemodynamic stability and may reduce the risk of intraventricular hemorrhage (IVH) and the vulnerability of infants to inflammatory processes. This blood also contains stem cells that are important in repairing tissue and building immunocompetence.
The current randomized controlled trial prospectively tested the effects of DCC for 30-45 seconds followed by 1 cord milking with the aim of confirming our prior work and providing long-term follow-up. Our a priori hypotheses were that DCC would reduce the incidence of IVH, LOS, and result in better motor function at 18-22 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women pregnant with gestation 24 to 31.6 weeks of singleton pregnancy by obstetrical evaluation
- •Obstetrician's approval of enrollment into study
- •Parental consent
- •Any mode of birth will be included
排除标准
- •Obstetrician's refusal to enroll infants
- •Parental refusal for consent
- •Prenatally-diagnosed major congenital anomalies [or multiple gestations]
- •Intent to withhold or withdraw care
- •Severe or multiple maternal illnesses, frank vaginal bleeding, placenta abruption or previa
- •Mothers who are institutionalized or psychotic
结局指标
主要结局
VLBW infants in the delayed clamped group will have less chronic lung disease at 36 weeks postmenstrual age compared to VLBW infants in the immediate cord clamped grouped
时间窗: 36 wks postmenstrual age
VLBW infants in the delayed clamped group will have better motor function by 6 to corrected age when compared with VLBW infants in the immediate cord clamped group
时间窗: 7 months corrected age
VLBW infants in the delayed clamped group will have fewer incidences of suspected necrotizing enterocolitis during the NICU stay when compared with VLBW infants in the immediate cord clamped group
时间窗: Hospital discharge
次要结局
- Infants in the delayed cord clamping group will have less IVH than infants in the immediate clamping group(NICU stay)
- Infants in the delayed clamping group will hvae less late onset sepsis than infants in the immediate clamping group.(NICU Stay)
研究者
Judith S Mercer
Professor Emerita
University of Rhode Island