EUCTR2007-002434-10-FR进行中（未招募）1 期
A prospective, randomised, double-blind crossover study comparing 0.15 g/L rhBSSL added to pasteurized breast milk versus placebo during one week of treatment in preterm infants born before week 32 of gestational age - BVT. BSSL - 021
Biovitrum AB (publ.)0 个研究点目标入组 32 人开始时间: 2007年7月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 32
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Preterm infants born before week 32 of gestation and who are less or equal than 32 weeks of gestation (extrapolated age) at the time of enrollment
- •2.Preterm infants appropriate for gestational age (each site should use its own growth curves or procedures and keep a copy of those used in the investigator’s file. The same growth curve should be used for all patients at one site)
- •3.Preterm infants receiving pasteurized breast milk
- •4.Preterm infants, enterally fed via nasal tube or bottle
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Infants receiving parenteral nutrition (except glucose)
- •2.Infants receiving milk fortifiers other than Eoprotin® (eg, Enfamil, Nutriprem)
- •a.Otherwise eligible infants who are receiving milk fortifiers other than Eoprotin® may be enrolled if the use of fortifiers is discontinued 2 days before the first dose
- •3.Infants requiring mechanical ventilation
- •4.Infants small for their gestational age (SGA)
- •5.Infants requiring =30% O2
- •6.Infants receiving phototherapy (babies who have completed phototherapy and otherwise qualify for the study may be admitted)
- •7.Infants with severe brain disease including grade III or IV periventricular or intra ventricular hemorrhage, meningitis or hydrocephalus, intracranial hemorrhage of grade III or IV, periventricular leukomalacia
- •8.Major dysmorphology or congenital abnormalities that can affect growth and development
- •9.Infants with hemodynamically significant persistent ductus arteriosus (PDA)
- •10.Clinical evidence of sepsis (including low or high white cell count and/or low platelet count, and bacteriologically proven evidence of systemic infection)
- •11.Documented congenital infection (eg CMV)
- •12.Presence of necrotizing enterocolitis
- •13.Haemorrhagic pulmonary events
- •14.Prior or concomitant treatment with corticosteroids, except hydrocortisone
- •15.Any condition which in the opinion of the investigator makes the patient unsuitable for inclusion
- •16.Enrollment in another concurrent clinical study within 2 days of the screening visit through the completion of the follow-up visit
研究者
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