NL-OMON55914招募中3 期
Protecting late-moderate preterm infants from respiratory tract infections and wheeze in their first yearsof life by using bacterial lysates. - PROTEA
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 0 至 0（—）
入选标准
- •Gestational age at delivery between 30+0 and 35+6 weeks
- •Postnatal age at least 6 weeks at randomization & postmenstrual age at least 37
- •Written informed consent by both parents or formal caregivers
排除标准
- •Underlying other severe respiratory disease such as broncho-pulmonary dysplasia
- •(unexpected in this group); hemodynamic significant cardiac disease;
- •immunodeficiency; severe failure to thrive; birth asphyxia with predicted poor
- •neurological out-come; syndrome or serious congenital disorder.
- •Dysmaturity and/or weight < 2.5 kg at age of randomization.
- •Maternal TNF-alpha inhibitors or other immunosuppression during pregnancy
- •and/or breastfeeding
- •Parents unable to speak and read Dutch/English language
- •Known allergic hypersensitivity to the active ingredients/substance or to any
- •of the excipients.
研究者
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