Birth Cohort Study for Respiratory Infections

Study Overview
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Brief Summary
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The primary objectives are to evaluate relationship between nasopharyngeal microbial colonization and the occurrence of AOM or pneumonia in infants.

Official Title
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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

Conditions
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Upper Respiratory Tract Infections

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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 35. 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Mother/child pair<br>Mother/child pair. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection) |  | 2 years | 
| Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota |  | 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 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of maternal urogenital infection |  | 2 years | 
| Birth outcome |  | 2 years |