This trial is active, not recruiting.

Condition upper respiratory tract infections
Sponsor Nestlé
Start date July 2012
End date September 2016
Trial size 300 participants
Trial identifier NCT02361164, 11.11.NRC


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Mother/child pair.

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

Secondary Outcomes

Incidence of maternal urogenital infection
time frame: 2 years
Birth outcome
time frame: 2 years

Eligibility Criteria

Female participants from 18 years up to 35 years old.

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

Additional Information

Official title 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
Principal investigator Shafiqul Alam Sarker, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in January 2017.
Information provided to ClinicalTrials.gov by Nestlé.