Birth Cohort Study for Respiratory Infections

NCT02361164 | Completed

• 1 other identifier: 11.11.NRC
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Upper Respiratory Tract Infections

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Incidence of maternal urogenital infection

  2 years

• Birth outcome

  2 years

Other Outcomes (2)

• Evaluation of FUT2/3 polymorphism and association with infant health outcomes

  One time point during the study

• Incidence of diarrhea and evaluation of gut health in infants

  2 years

Study Arms (1)

Mother/child pair

Mother/child pair.

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Community sample

You may qualify if:

• 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

You may not qualify if:

• 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
• RhD negative mother
• APH/Placental abruption
• Placenta Praevia
• Unstable lie
• Multiple pregnancy
• Pregnancy induced hypertension (systolic \> 140 mm of Hg, diastolic \> 90 mm of Hg)
• Severe pre-eclampsia or eclampsia
• Gestational diabetes
• Onstetric cholestasis

Sponsors & Collaborators

• Société des Produits Nestlé (SPN): lead

Study Sites (1)

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples, clinical samples for bacterial and viral isolates

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Shafiqul Alam Sarker, M.D.

  International Center for Diarrheal Disease Research, Bangladesh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2015
• First Posted: February 11, 2015
• Study Start: July 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: March 1, 2017
• Last Updated: April 9, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)