跳至主要内容
临床试验/NCT02212002
NCT02212002已完成不适用

Effect of Intrapartum Antibiotic Prophylaxis (IAP) on the Development of Neonatal Gut Microbiota

IRCCS Azienda Ospedaliero-Universitaria di Bologna1 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
84
试验地点
1
主要终点
Faecal bacterial count

研究概览

简要总结

The colonization of the neonatal gastro-intestinal (GI) tract begins at birth and is influenced by several factors, such as mode of delivery, gestational age, maternal intestinal and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics and probiotics.

Gut microbiota of term infants, vaginally delivered and exclusively breastfed, shows a low count of C. difficile and E. coli and a high number of Bifidobacteria and Lactobacilli, which positively influence the host's immunity processes; hence, is considered to be ideally healthy.

Group B Streptococcus (GBS) represents one of the most important causes of neonatal infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process from maternal vagina, cervix or rectum, where it resides in 10-20% of pregnant women. In the last decade, the incidence of early-onset GBS sepsis is significantly reduced, due to the introduction of GBS universal screening during late pregnancy and consequent intrapartum antibiotic prophylaxis (IAP) in GBS-positive women.

The use of antibiotics in early life is shown to alter the commensal gut microbiota, thereby impairing the balance between health and disease later in life. The effect of IAP on bacterial colonization of the infant's gut, however, has not been largely investigated. The investigators have previously evaluated the effect of IAP in a relatively small sample of exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at 7 days of life there were several differences in microbiota composition between infants IAP-exposed and not exposed.

This observational prospective study thus aims to evaluate these differences in further detail, expanding the initial sample to formula-fed term infants and following up infants until one month of age. By including formula-fed infants, the investigators additionally aim to evaluate the influence of feeding type on the neonatal microbiota composition.

详细描述

At birth, the neonatal gastro-intestinal (GI) tract is rapidly colonized by maternal and environmental bacteria; the first colonizers are generally aerobes and facultative anaerobes, followed by strict anaerobes (e.g. Bifidobacterium spp., Bacteroides spp., and Clostridium spp.). The composition of gut microbiota is influenced by several factors, such as mode of delivery, gestational age, maternal intestinal and vaginal microbiota, type of feeding, hospitalization after birth and use of antibiotics and probiotics.

Gut microbiota of term infants, vaginally delivered and exclusively breastfed, is considered to be ideally healthy, with a low count of C. difficile and E. coli and a high number of Bidifobacteria and Lactobacilli, which positively influence the host's health by activating immunocompetent cells in the GI tract, promoting the production of secretory IgA and increasing the bactericidal activity of neutrophils and cell-mediated immunity such as NK cell activity.

Group B Streptococcus (GBS) is one of the most important causes of neonatal infections and sepsis. Infants vaginally delivered may acquire GBS during the birth process from maternal vagina, cervix or rectum, where it resides in approximately 10-20% of pregnant women. Since the mid-90s, the incidence of early-onset GBS sepsis is significantly reduced, due to the introduction of GBS universal screening during late pregnancy and consequent intrapartum antibiotic prophylaxis (IAP) in GBS-positive women.

Recent data suggest that the use of antibiotics in early life could alter the commensal gut microbiota, thereby impairing the balance between health and disease later in life. The effect of IAP on bacterial colonization of the infant's gut has not been largely investigated. Moreover, currently available data on this issue largely derive from studies performed using culture-based techniques; however, accurate culture-based results are influenced by the selection of the correct media, temperature, oxygen content and time for growth, and for this reason as little as 10-50% of the entire gut bacteria are easily cultured. Molecular techniques, based on the amplification of the 16S ribosomal bacterial RNA gene to differentiate prokaryotic taxa, have been recently developed for the study of gut microbiota, thus enabling a more detailed characterization of bacterial communities than standard culture.

We have previously evaluated the effect of IAP in a relatively small sample of exclusively breast-fed term infants vaginally delivered by means of molecular techniques; at 7 days of life there were several differences in microbiota composition between infants IAP-exposed and not exposed.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
— 至 6 Days(Child)
性别
All
接受健康志愿者

入选标准

  • Term newborns (gestational age ≥ 37 weeks), vaginally delivered newborn
  • birth weight adequate for gestational age
  • mothers screened for GBS at 35-37 weeks gestation
  • Obtained written parental consent.

排除标准

  • Preterm or small/large for gestational age infants;
  • Infants born by caesarean section;
  • Infants admitted to the Neonatal Intensive Care Unit;
  • Infants with major congenital malformations;
  • Infants who received any antibiotic treatment after birth;
  • Signs of infection and/or any serious clinical conditions that contraindicate the participation in the study;
  • Infants whose mother had received any antibiotic in the 4 weeks before delivery;
  • maternal IAP performed for reasons other than GBS positivity (i.e. prolonged rupture of membranes in GBS-negative women);
  • inadequate maternal IAP;
  • maternal IAP performed with antibiotics other than ampicillin, such as erythromycin

研究组 & 干预措施

IAP

IAP group: infants born to GBS-positive mothers who have received adequate intrapartum antibiotic prophylaxis (IAP). According to the Institutional treatment protocol for GBS prophylaxis (derived from CDC guidelines), intravenous ampicillin is given every 4 hours until delivery (first dose 2 g, following doses 1 g each). IAP is considered adequate when the mother received at least two doses of ampicillin before delivery.

干预措施: IAP (Drug)

结局指标

主要结局

Faecal bacterial count

时间窗: One month

Reduction in the faecal bacterial count (Bifidobacterium spp., Lactobacillus spp. and Bacteroides fragilis), assessed in term and vaginally delivered infants, in relation to IAP exposition.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Luigi Corvaglia

Associate Professor

IRCCS Azienda Ospedaliero-Universitaria di Bologna

研究点 (1)

Loading locations...

相似试验