Prospective, Community-based, Longitudinal Dynamic Birth Cohort Study of Respiratory and Gastrointestinal Pathogen Identification in Brisbane Infants.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 165
- 试验地点
- 2
- 主要终点
- Acute respiratory illness (ARIs) and acute gastrointestinal (AGE) illness rates per 10,000 child-days in healthy children in the first two years of life
研究概览
简要总结
In this study, the investigator will be approaching pregnant women to undertake 2 years of weekly respiratory and nappy specimen collection from their healthy new born infant. These specimens will be mailed to the Queensland Paediatric Infectious Diseases (Qpid) Laboratory where they will be stored and batched tested for viruses and bacteria. As well as this, parents will keep a simple daily symptom diary for their child, allowing us to match detection of viruses and bacteria to periods when the study child did or did not have symptoms. This will help our understanding of what finding these viruses and bacteria in specimens from children really means.
详细描述
This will be a prospective, community-based longitudinal birth cohort study of respiratory and gastrointestinal pathogen detection in Brisbane infants. The enrollment target of 138 children will take 2 years to achieve, each child will be followed until their second birthday, and a final year will be required for specimen and data analysis; for a total duration of the study of 5 years.
Women are to be recruited antenatally over a period of two years from study commencement (mid-2010). These hospitals serve communities from the north of Brisbane, a city of almost 2 million people, and every year each has roughly 5,200 (RBWH) and 1,700 (North West) annual deliveries respectively. The investigators will follow 138 infants from birth until their second birthday. Where a family drops out of the study or is lost to follow-up, they will be replaced to maintain overall person-time for the study.
The progressive 2 year recruitment plan allows for seasonal and year-to-year variation in respiratory virus activity. Eligible infants will be healthy term babies without conditions that predispose to more frequent or severe infectious episodes.
Parents will keep a simple, daily, infection symptom diary, completed using tick boxes and numbers, which the investigators will request be returned on a 4-weekly basis. A similar diary was used for a 12-month cohort study conducted in Melbourne (2003-2004) with excellent return rate and acceptability by study families.
Study families are to be contacted monthly by their preferred method of communication (telephone, SMS, or email) to encourage continued performance of study tasks and answer study related questions.
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
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •pregnant women expecting to deliver a healthy, term baby
- •written informed consent from pregnant woman who is available for telephone contact for the duration of the study, and not planning to move out of the study area
- •parent willing to collect a weekly anterior nasal specimen and stool (nappy) specimen from the study child and return to study site via mail
- •parent or guardian with sufficient English language skills to complete study diaries and perform study tasks as required
排除标准
- •children born before 36 weeks
- •children with chronic pulmonary or cardiovascular disorders
- •children with chronic metabolic disorders (such as, but not limited to, diabetes mellitus, renal dysfunction, haemoglobinopathies)
- •children with immune system disorders (such as HIV/AIDS or receiving immune system suppressing medications)
- •children with other chronic illnesses whose enrollment is deemed by the investigators to make it inappropriate to enroll them onto, or to continue in, the study
结局指标
主要结局
Acute respiratory illness (ARIs) and acute gastrointestinal (AGE) illness rates per 10,000 child-days in healthy children in the first two years of life
时间窗: Two years
This measure will be calculated using counts of ARIs and AGE in study children during the first two years of life as the numerator, and person-time in child-months on the study as the denominator.
次要结局
- Pathogen-specific rate of episodes of ARI and AGE per 10,000 child-days in healthy children in the first two years of life(2 years)
- Detection of novel pathogens in healthy children in the first 2 years of life.(2 years)
研究者
Dr Stephen Lambert
Senior Research Fellow
The University of Queensland