DOUBLE BLIND STUDY OF GCSF ADMINISTRATION TO NEONATES WITH NEUTROPENIA

GCSF 对中性粒细胞减少症新生儿给药的双盲研究

• 批准号: 6218432
• 负责人: KURT R SCHIBLER
• 金额: $ 0.16万
• 依托单位: UNIVERSITY OF UTAH
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6218432
• 关键词: blood disorder chemotherapy; blood toxicology; clinical research; colitis; colony stimulating factor; drug screening /evaluation; granulocytopenia; human subject; human therapy evaluation; immunotherapy; neutrophil; newborn human (0-6 weeks); pediatric pharmacology; placebos; pregnancy toxemia /hypertension

This study has now been completed, and the results have been published (Pediatrics (1998), 102:6-13). This study involved the administration of recombinant G-CSF (or placebo) to newborn infants with neutropenia associated with either early-onset sepsis, maternal hypertension, late-onset sepsis, or necrotizing enterocolitis. The effects of treatment or placebo were assessed by measuring four outcome variables: blood neutrophil concentration, neutrophil production and function, severity of illness, and duration of illness. The study demonstrated that G-CSF was effective in correcting the neutropenia commonly found in septic newborn infants. In spite of correction of the neutropenia, there was little evidence of shortened Intensive Care Unit stays or of shortened total hospitalization time.

这项研究现在已经完成，结果已经发表(儿科(1998)，102：6-13)。这项研究涉及对早发性败血症、母体高血压、迟发性败血症或坏死性小肠结肠炎合并中性粒细胞减少症的新生儿给予重组G-CSF(或安慰剂)。通过测量四个结果变量来评估治疗或安慰剂的效果：血液中性粒细胞浓度、中性粒细胞产生和功能、病情严重程度和病程。研究表明，G-CSF对纠正败血症新生儿中常见的中性粒细胞减少症是有效的。尽管中性粒细胞减少得到纠正，但几乎没有证据表明重症监护病房住院时间或总住院时间缩短。