Actively Recruiting
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
Eligibility Criteria
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
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
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
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
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
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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