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 site in 1 country300 target enrollmentJuly 2012

ConditionsUpper Respiratory Tract Infections

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Upper Respiratory Tract Infections
Sponsor: Société des Produits Nestlé (SPN)
Enrollment: 300
Locations: 1
Primary Endpoint: Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

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

Registry

clinicaltrials.gov

Start Date

July 2012

End Date

March 2017

Last Updated

8 years ago

Study Type

Observational

Sex

Female

Investigators

Sponsor

Société des Produits Nestlé (SPN)

Responsible Party

Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)

Time Frame: 2 years

Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota

Time Frame: 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

Time Frame: 2 years