NL-OMON33555尚未招募不适用
Influences of antibiotics on biodiversity of intestinal microbiota in newborns - Biodiversity of Intestinal Microbiota & Antibiotics (BIMA)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 2 至 99（—）
入选标准
- •Inclusion criteria Group 1
- •Newborn infants born by vaginal delivery
- •Without any complications during both intrauterine and intra partum period
- •No antenatal/postnatal antibiotics
- •Normal healthy infant
- •Breastfed;Inclusion criteria Group 2
- •Newborn infants born by vaginal delivery
- •Without complications during both intrauterine and intra partum period except minor risk factors (GBS colonisation, unknown GBS status, Temp < 39°C) to prescribe antenatal antibiotics to the mother
- •Antenatal antibiotics I.V. (2-8 hours before delivery)
- •No postnatal antibiotics
- •Normal healthy infant
- •Breastfed;Inclusion criteria Group 3
- •Newborn infants born by vaginal delivery
- •Without any complications during both intrauterine and intra partum period
- •No antenatal antibiotics
- •Postnatal antibiotic therapy started within first 12 hours after birth and discontinued within 48-72 hours (discontinued course of antibiotics).
- •Normal healthy infant with low risk for early onset sepsis
- •Breastfed;Inclusion criteria Group 4
- •Newborn infants born by vaginal delivery
- •Without any complications during both intrauterine and intra partum period
- •No antenatal antibiotics
- •Postnatal antibiotic therapy started within first 12 hours after birth and discontinued after one week (full course of antibiotics).
- •Normal healthy infant in whom an early onset sepsis could not be excluded.
- •Breastfed;Inclusion criteria Group 5
- •Newborn infants born by cesarean section
- •Without any complications during both intrauterine and intra partum period
- •No antenatal/postnatal antibiotics
- •Normal healthy infant
- •Breastfed
排除标准
- •- APGAR Score after 5 minutes < 6
- •- Major congenital abnormality
- •- Congenital abnormonality of gastro intestinal tract
研究者
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