Birth Cohort Study for Respiratory Infections

Nestlé

Status: Completed

Conditions: Upper Respiratory Tract Infections

Study type: Observational

Funder types: Industry

Identifiers

NCT02361164

11.11.NRC

Details and patient eligibility

About

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

Enrollment: 300 patients

Sex: Female

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

300 participants in 1 patient group

Mother/child pair

Description:

Mother/child pair.