Clinical trial NCT02361164: Birth Cohort Study for Respiratory Infections
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Upper Respiratory Tract Infections
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2015-02-11
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample

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


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

  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

Primary outcomes:
measure: Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)
timeFrame: 2 years
measure: Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota
timeFrame: 2 years
measure: Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors
timeFrame: 2 years
Secondary outcomes:
measure: Incidence of maternal urogenital infection
timeFrame: 2 years
measure: Birth outcome
timeFrame: 2 years
Other outcomes:
measure: Evaluation of FUT2/3 polymorphism and association with infant health outcomes
timeFrame: One time point during the study
measure: Incidence of diarrhea and evaluation of gut health in infants
timeFrame: 2 years
Locations:
city: Dhaka
country: Bangladesh
facility: International Center for Diarrheal Disease Research
Study officials:
affiliation: International Center for Diarrheal Disease Research, Bangladesh
name: Shafiqul Alam Sarker, M.D.
role: PRINCIPAL_INVESTIGATOR
References: