Birth Cohort Study for Respiratory Infections

Completed

• Conditions: Upper Respiratory Tract Infections

• Registration Number: NCT02361164
• Lead Sponsor: Société des Produits Nestlé (SPN)

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2015-02-06
• Study First Submitted QC: 2015-02-06
• Study First Posted: 2015-02-11
• Primary Completion: 2016-09
• Study Completion: 2017-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-05
• Last Update Posted: 2018-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Incidence of maternal urogenital infection	2 years
Birth outcome	2 years

Trial Locations

Locations (1)

International Center for Diarrheal Disease Research; 🇧🇩 Dhaka, Bangladesh