Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection (IVIG)
Randomized Clinical Trial of Intravenous Immune Globulin (IVIG) to Prevent Neonatal Infection in Very-Low-Birth-Weight Infants
研究概览
详细说明
Although survival rates for very-low-birth-weight infants (≤ 1.5 kg) continue to increase, nosocomial infections remain a major cause of morbidity and mortality. Prolonged hospitalization with exposure to resistant organisms and multiple invasive procedures, in the presence of immunologic immaturity, renders these infants vulnerable to hospital-acquired infections. Prior studies testing the ability of intravenous immune globulin to prevent nosocomial infections in premature infants have varied in design and sample size. Despite differences in the rates of observed infection, immune globulin preparations, doses, and infusion intervals, a meta-analysis of published reports suggests that nosocomial infections may be diminished by the prophylactic infusion of IgG.
The National Institute of Child Health and Human Development (NICHD) Neonatal Research Network therefore performed a prospective, multicenter, randomized trial at eight participating centers to test the hypothesis that the intravenous administration of immune globulin to infants with birth weights between 501 and 1500g would reduce the incidence of nosocomial infections.
Patients were randomly assigned to an intravenous immune globulin group or a control group. During phase 1 the control infants received infusions of placebo. During phase 2 the control infants received no infusion therapy.
研究类型
注册 (实际的)
阶段
- 阶段2
- 第三阶段
联系人和位置
学习地点
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Alabama
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Birmingham、Alabama、美国、35233
- University of Alabama at Birmingham
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District of Columbia
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Washington、District of Columbia、美国、20052
- George Washington University
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Florida
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Miami、Florida、美国、33136
- University of Miami
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Michigan
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Detroit、Michigan、美国、48201
- Wayne State University
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Ohio
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Cleveland、Ohio、美国、44106
- Case Western Reserve University, Rainbow Babies and Children's Hospital
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Tennessee
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Memphis、Tennessee、美国、38163
- University of Tennessee
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Texas
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Dallas、Texas、美国、75235
- University of Texas Southwestern Medical Center at Dallas
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Vermont
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Burlington、Vermont、美国、05405
- University of Vermont
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- All neonates with birth weights of 501 to 1500 g
Exclusion Criteria:
- More than 72 hours old
- One of three or more fetuses from a multiple pregnancy
- Had infections associated with toxoplasma, rubella, cytomegalovirus, and herpes simplex viruses (the TORCH complex)
- Has a major congenital malformation, an identifiable syndrome, or a chromosomal abnormality
- Were considered nonviable
- Parental consent could not be obtained
学习计划
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Immune globulin
Lyophilized human immune globulin product
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The infants received their first dose of study drug within 24 hours of randomization.
其他名称：
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安慰剂比较：Albumin solution
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An equal volume of 5 percent albumin solution
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Incidence of nosocomial infection
大体时间：120 days of life
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Including septicemia, meningitis, or urinary tract infection
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120 days of life
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Death
大体时间：120 Days of life
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120 Days of life
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Morbidity
大体时间：120 days of life
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Duration of ventilator support, frequency of bronchopulmonary dysplasia, and duration of hospitalization
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120 days of life
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Local infections
大体时间：120 days of life
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120 days of life
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Necrotizing enterocolitis
大体时间：120 days of life
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120 days of life
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Specific complications of immune globulin or placebo infusion
大体时间：120 days of life
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120 days of life
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合作者和调查者
调查人员
- 研究主任：Avroy A. Fanaroff, MD、Case Western Reserve University
- 首席研究员：Ronald L. Poland, MD、Wayne State University
- 首席研究员：Joseph B. Philips, MD、University of Alabama at Birmingham
- 首席研究员：Jerold F. Lucey, MD、University of Vermont, Burlington
出版物和有用的链接
一般刊物
- Fanaroff AA, Korones SB, Wright LL, Verter J, Poland RL, Bauer CR, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, Catz CS, Shankaran S, Oh W. Incidence, presenting features, risk factors and significance of late onset septicemia in very low birth weight infants. The National Institute of Child Health and Human Development Neonatal Research Network. Pediatr Infect Dis J. 1998 Jul;17(7):593-8. doi: 10.1097/00006454-199807000-00004.
- Fanaroff AA, Korones SB, Wright LL, Wright EC, Poland RL, Bauer CB, Tyson JE, Philips JB 3rd, Edwards W, Lucey JF, et al. A controlled trial of intravenous immune globulin to reduce nosocomial infections in very-low-birth-weight infants. National Institute of Child Health and Human Development Neonatal Research Network. N Engl J Med. 1994 Apr 21;330(16):1107-13. doi: 10.1056/NEJM199404213301602.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- NICHD-NRN-0002
- U10HD021364 (美国 NIH 拨款/合同)
- U10HD021373 (美国 NIH 拨款/合同)
- U10HD021385 (美国 NIH 拨款/合同)
- U01HD019897 (美国 NIH 拨款/合同)
- U10HD021415 (美国 NIH 拨款/合同)
- U10HD021397 (美国 NIH 拨款/合同)
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