Actively Recruiting

Age: 0 - 29Days
All Genders
Healthy Volunteers
ID07249996

Respiratory Infections in Young Children in Colombia and Panamá: Studying Causes, Interactions, and Long-Term Effects

Led by Eduardo Lopez -Medina · Updated on 2025-11-25

1088

Participants Needed

2

Research Sites

34 weeks

Total Duration

On this page

Sponsors

E

Eduardo Lopez -Medina

Lead Sponsor

M

Merck Sharp & Dohme LLC

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are studying respiratory tract infections (RTIs) in young children from birth to five years old in Colombia and Panamá. The study aims to understand how often these infections occur, which viruses or bacteria cause them, and why some children experience more severe illness. It also explores how early infections and vaccinations affect the immune system and long-term respiratory health. This observational study follows newborns over time to learn about the causes and effects of RTIs in community settings, especially where data is limited. The study involves active monitoring of children from birth until age five. Families are contacted twice weekly via a phone app or calls to track symptoms. If a child becomes ill, they attend in-person visits where nasal and blood samples are collected to identify pathogens and study immune responses. Routine check-ups occur every six months during the first two years, then continue biannually until age five to observe long-term outcomes. No experimental treatments are given. Participants' parents or guardians provide informed consent and help with ongoing data and sample collection. The research team measures the incidence and severity of infections, including hospitalizations and intensive care needs, and examines bacterial loads and immune system reactions. This long-term follow-up helps understand RTIs' impact on children's health and supports future prevention and treatment efforts. The study began in May 2024 and will continue until children reach five years old.

CONDITIONS

Brief Title

Respiratory Infections in Young Children

Who Can Participate

Age: 0 - 29Days
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Newborns younger than 29 days of life, with or without pre-existing conditions
  • Parent(s) or guardian(s) must be available for telephone contact throughout the study
  • Parent(s) or guardian(s) must provide informed consent to participate
  • Parent(s) or guardian(s) must authorize data and specimen collection, storage, and analysis
Not Eligible

You will not qualify if you...

  • Infants born to a pregnant mother under 14 years of age (as legally presumed to result from sexual abuse)

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit

Surveillance

Duration - From birth to 2 years of age

Participants are actively monitored twice a week by phone app or calls to detect respiratory infections, with in-person visits during respiratory tract infection episodes.

Twice-weekly contacts and additional in-person visits during infection episodes

Long-term Monitoring

Duration - From 2 to 5 years of age

Participants continue follow-up visits every six months to assess long-term respiratory health outcomes up to five years of age.

Routine visits every six months

Trial Site Locations

Total: 2 locations

1

Centro de Estudios en Infectologia Pediatrica, CEIP

Cali, Valle del Cauca Department, Colombia

Actively Recruiting

2

Cevaxin

Panama City, Panama

Actively Recruiting

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Research Team

E

Eduardo Lopez-Medina, MD, MSc

R

Rodrigo DeAntonio, MD

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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