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OpenTrials
Completed

NCT Number: NCT02361164

Birth Cohort Study for Respiratory Infections

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

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Key information

Age range

18 year–35 year

Sex eligibility

Female

Study type

Observational

Primary location

International Center for Diarrheal Disease Research

Dhaka, Bangladesh

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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
  • Current history of drug/alcohol abuse
  • BMI of less than 18.5 or more than 35. Severe pallor as detected clinically or by HB level (< 7 gm/dL), and oedema
  • Blood samples drawn and tested for VDRL (Positive VDRL) Cephalopelvic disproportion (CPD)
  • History of taking antibiotic within 3 weeks prior to this study
  • Patient unwilling to comply with study protocol

Treatment and study plan

Primary outcomes

  1. Incidence of respiratory disease (Acute Otitis Media, Acute Respiratory Infection)

    Time frame: 2 years

  2. Naso-/oro-Pharyngeal colonization with specific pathogens and microbiota

    Time frame: 2 years

  3. Risk factors for recurrent Upper Respiratory Track Infection in terms of bacteria or virus, nutritional and immune status, as well as epidemiological factors

    Time frame: 2 years

Secondary outcomes

  1. Incidence of maternal urogenital infection

    Time frame: 2 years

  2. Birth outcome

    Time frame: 2 years

Other outcomes

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

    Time frame: One time point during the study

    Analysis on saliva samples

  2. Incidence of diarrhea and evaluation of gut health in infants

    Time frame: 2 years

    Analysis of fecal samples

Sponsors and collaborators

Lead sponsor

Société des Produits Nestlé (SPN)

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2016
Study completion
2017
First posted
Feb 11, 2015
Registry last updated
Apr 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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