Respiratory infections in newborns and children up to five years

Respiratory Infections in Young Children in Colombia and Panamá: Epidemiology, Interactions, and Long-term Consequences.

This project will follow newborns in Colombia and Panamá through age five to see how often respiratory infections happen, which germs cause them, and how those infections affect long-term lung health.

Quick facts

• Study type: Observational
• Enrollment: 1088 (estimated)
• Ages: N/A to 29 Days
• Sex: All
• Sponsor: Centro de Estudios en Infectogía Pediatrica (other)
• Locations: 2 sites (Cali, Valle del Cauca Department and 1 other locations)
• Trial ID: NCT07249996 on ClinicalTrials.gov

What this trial studies

This is a multicenter prospective birth cohort that enrolls newborns and follows them until age five to define the frequency, causes, severity, and long-term consequences of respiratory tract infections. Families are contacted twice weekly via a phone app or calls for active surveillance, with in-person visits during infection episodes and routine checkups every six months in the first two years and then continuing through age five. Respiratory specimens and clinical data are collected to identify viral and bacterial pathogens, study interactions between microbes, and measure immune responses and health outcomes over time. The study is observational and does not provide experimental treatments.

Who should consider this trial

Good fit: Newborns younger than 29 days whose parent or guardian can give informed consent, remain reachable by phone, and do not plan to relocate from the study area are ideal candidates.

Not a fit: Infants who cannot be reached by phone, intend to move away from the study locations, are older than the 29-day enrollment window, or who need experimental treatments are unlikely to benefit directly from participation.

Why it matters

Potential benefit: If successful, the findings could help prevent and better manage respiratory infections in young children by identifying common causes, risk factors for severe disease, and immune patterns linked to later lung health.

How similar studies have performed: Previous birth cohort studies have successfully defined viral causes of early-childhood RTIs, but community-based longitudinal cohorts in Latin America are limited, so this study builds on known methods while filling a regional evidence gap.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Where this trial is running

Cali, Valle del Cauca Department and 1 other locations

• Centro de Estudios en Infectologia Pediatrica, CEIP — Cali, Valle del Cauca Department, Colombia (RECRUITING)
• Cevaxin — Panama City, Panama (RECRUITING)

Study contacts

• Principal investigator: Eduardo Lopez-Medina, MD, MSc — Centro de Estudios en Infectologia Pediatrica, CEIP
• Study coordinator: Eduardo Lopez-Medina, MD, MSc

Conditions: Respiratory Tract Infections, Lower Respiratory Tract Infection, Viral Infections, Cohort Study, Birth Cohort Study, Respiratory Tract Infection, Children