NCT02361164已完成不适用
Prospective Two-year Observational Study to Evaluate the Effect of Bacterial Colonisation of the Nasopharynx on the Occurence of Acute Respiratory Infections in a Birth Cohort of Children and Their Mothers
Société des Produits Nestlé (SPN)1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2012年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
研究概览
简要总结
The primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age: 18-35 years
- •Parity: any but with history of previous normal delivery
- •Weight: Body Mass Index greater than 18.5 but less than 35
- •Past obstetric history: Uncomplicated pregnancy, unremarkable medical and obstetric conditions
- •Current pregnancy: Uneventful progression of pregnancy
- •General health: Normal health related functional status during pregnancy
- •Singleton pregnancy as determined by clinical examination and/or by ultrasonography
- •Cephalic presentation as determined by abdominal clinical examination
- •Expected to have normal pregnancy related outcome
- •Written informed consent
排除标准
- •Medical history: Known history of diabetes, hypertension, or any systemic disorder
- •Gynecological history: History of major gynecological problem/treatment
- •Complications in previous pregnancy
- •Previous obstetric cholestasis
- •Previous acute fatty liver disease
- •Conditions during current pregnancy
- •RhD negative mother
- •APH/Placental abruption
- •Placenta Praevia
- •Unstable lie
- •Multiple pregnancy
- •Pregnancy induced hypertension (systolic > 140 mm of Hg, diastolic > 90 mm of Hg)
- •Severe pre-eclampsia or eclampsia
- •Gestational diabetes
- •Onstetric cholestasis
- •Current history of drug/alcohol abuse
- •BMI of less than 18.5 or more than
- •Severe pallor as detected clinically or by HB level (< 7 gm/dL), and oedema
- •Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD)
- •History of taking antibiotic within 3 weeks prior to this study
- •Patient unwilling to comply with study protocol
结局指标
主要结局
Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
时间窗: 2 years
Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota
时间窗: 2 years
Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors
时间窗: 2 years
次要结局
- Incidence of maternal urogenital infection(2 years)
- Birth outcome(2 years)
研究者
研究点 (1)
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