Birth Cohort Study for Respiratory Infections

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02361164

Enrollment

300

Registered

2015-02-11

Start date

2012-07-31

Completion date

2017-03-31

Last updated

2018-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Upper Respiratory Tract Infections

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 35 Years

Healthy volunteers

Yes

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 1. RhD negative mother 2. APH/Placental abruption 3. Placenta Praevia 4. Unstable lie 5. Multiple pregnancy 6. Pregnancy induced hypertension (systolic \> 140 mm of Hg, diastolic \> 90 mm of Hg) 7. Severe pre-eclampsia or eclampsia 8. Gestational diabetes 9. Onstetric cholestasis 10. Current history of drug/alcohol abuse 11. BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by HB level (\< 7 gm/dL), and oedema 12. Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD) 13. History of taking antibiotic within 3 weeks prior to this study 14. Patient unwilling to comply with study protocol

Design outcomes

Primary

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

Measure	Time frame
Birth outcome	2 years
Incidence of maternal urogenital infection	2 years

Other

Measure	Time frame	Description
Evaluation of FUT2/3 polymorphism and association with infant health outcomes	One time point during the study	Analysis on saliva samples
Incidence of diarrhea and evaluation of gut health in infants	2 years	Analysis of fecal samples

Countries

Bangladesh

Outcome results