Birth Cohort Study for Respiratory Infections

Upper Respiratory Tract Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02361164
• Other study ID #: 11.11.NRC
• Status: Completed
• First received: February 6, 2015
• Last updated: April 5, 2018
• Start date: July 2012
• Est. completion date: March 2017

Study information

• Verified date: April 2018
• Source: Nestlé
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 300
• Est. completion date: March 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• Respiratory Tract Infections
• Upper Respiratory Tract Infections

Locations

Country	Name	City	State
Bangladesh	International Center for Diarrheal Disease Research	Dhaka

Sponsors (1)

Lead Sponsor	Collaborator
Nestlé

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Evaluation of FUT2/3 polymorphism and association with infant health outcomes	Analysis on saliva samples	One time point during the study
Other	Incidence of diarrhea and evaluation of gut health in infants	Analysis of fecal samples	2 years
Primary	Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)		2 years
Primary	Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota		2 years
Primary	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	Incidence of maternal urogenital infection		2 years
Secondary	Birth outcome		2 years