EUCTR2007-002434-10-IT进行中（未招募）不适用
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 - ND
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- BIOVITRUM AB
- 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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