The goal of this observational study is to learn about the causes, severity, and long-term effects of respiratory tract infections (RTIs) in young children from birth to five years of age in Colombia and Panamá. The main questions it aims to answer are:
How often do respiratory infections occur in children under two years old, and which viruses or bacteria cause them? Why do some children develop more severe infections than others? Do early infections or vaccinations change how the immune system responds to future illnesses? How do viruses and bacteria interact in the respiratory tract to influence disease severity and long-term respiratory health? Researchers will follow newborns from birth until age five to understand how respiratory infections develop and affect children's health over time. Participants will not receive any experimental treatment.
Families who join the study will:
Be contacted twice a week through a phone app or phone calls to check for symptoms of respiratory infection.
Attend in-person visits if their child becomes ill and every six months for routine follow-up.
Provide nasal and blood samples during illness episodes so researchers can identify the viruses or bacteria causing infection and study how the immune system responds.
This study began in May 2024 and is being conducted in Cali, Colombia, and Panamá City, Panamá. The research team plans to continue to include participants and continue active follow-up until the children reach five years of age.
The information collected will help scientists and health professionals understand how different pathogens cause respiratory infections, what factors increase the risk of severe illness, and how early infections may influence long-term lung health. The study's findings will support future efforts to prevent and treat respiratory diseases in young children.
Newborns younger than 29 days of life, with or without pre-existing conditions
Infants whose parent(s) or guardian(s) are available for telephone contact for the duration of the study, and do not intend to relocate outside of the study area, to ensure adherence to RTI and in-person visits.
Infants whose parent(s) or guardian(s) provide informed consent to participate in the study.
Infants whose parent(s) or guardian(s) are willing to authorize data and specimen collection, storage and analysis.
Infants born to a pregnant mother under 14 years of age (under Colombian law, pregnancies occurring in individuals younger than 14 years of age are legally presumed to result from sexual abuse).
Newborns younger than 29 days of life, with or without pre-existing conditions
Cohort
Prospective
Not listed
Incidence rate
The number and etiology of new cases of RTI and LRTI according to cumulative time at risk and month of occurrence, in children aged 0 to 2 years.
Severity by pathogen
Frequency of children who develop RTI, and mild, moderate or severe LRTI, according to pathogen and maximum level of care (outpatient care, emergency room, hospital admission or intensive care) and oxygen support (none, nasal canula, non-invasive ventilation or mechanical ventilation) received by children with LRTI, according to pathogen
Burden in in-patient and outpatient settings
Median Duration of symptoms, Hospitalization rates, Length of hospital stay, Use of medications, Antibiotic consumption, Lost workdays and daily activities due to illness
Pneumococcal bacterial load and Host immune response
Disease severity according to pneumococcal bacterial loads and whole blood transcriptome analysis.
Long term Sequelae
Prevalence of chronic respiratory illness, recurrent wheezing or asthma, up to 5 years of age, according to the etiology of lower RTI diagnosed during the first two years of life
Click on the lead sponsor to view all of their trials.
Eduardo Lopez -Medina
Lead sponsor
Centro de Estudios en Infectogía Pediatrica
Sponsor institution
Merck Sharp & Dohme LLC
Collaborator
