Birth Cohort Study for Respiratory Infections

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

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

Study Overview

• Status: Completed
• Conditions: Upper Respiratory Tract Infections

• Study Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Bangladesh
  • Dhaka, Bangladesh
    • International Center for Diarrheal Disease Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Community sample

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Mother/child pair; Mother/child pair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
Incidence of maternal urogenital infection	2 years
Birth outcome	2 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of FUT2/3 polymorphism and association with infant health outcomes	Analysis on saliva samples	One time point during the study
Incidence of diarrhea and evaluation of gut health in infants	Analysis of fecal samples	2 years

Collaborators and Investigators

• Sponsor: Nestlé
• Investigators: Principal Investigator: Shafiqul Alam Sarker, M.D., International Center for Diarrheal Disease Research, Bangladesh

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): March 1, 2017

Study Registration Dates

• First Submitted: February 6, 2015
• First Submitted That Met QC Criteria: February 6, 2015
• First Posted (Estimate): February 11, 2015

Study Record Updates

• Last Update Posted (Actual): April 9, 2018
• Last Update Submitted That Met QC Criteria: April 5, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 11.11.NRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO