Respiratory Infections in Young Children

NCT07249996 | Recruiting

• 1 other identifier: 103600
• Study Type: observational
• Target: 1,088
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Respiratory Tract Infections (RTI); Lower Respiratory Tract Infection (LRTI); Viral Infections; Cohort Study

Keywords

Birth Cohort Study; Respiratory Tract Infection (RTI); Children

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment, up to 2 years of age.

Secondary Outcomes (3)

• Severity by pathogen

  From enrollment, up to 2 years of age

• Burden in in-patient and outpatient settings

  From recruitment, up to 2 years of age

• Pneumococcal bacterial load and Host immune response

  From recruitment, up to 2 years of age

Other Outcomes (1)

• Long term Sequelae

  From recruitment to study completion at 5 years

Study Arms (1)

• 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, do not intend to relocate outside of the study area, provide informed consent to participate in the study and are willing to authorize data and specimen collection, storage and analysis.

Eligibility Criteria

• Age: Up to 29 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Newborns younger than 29 days of life, with or without pre-existing conditions

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eduardo Lopez -Medina: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Centro de Estudios en Infectologia Pediatrica, CEIP

Cali, Valle del Cauca Department, Colombia

RECRUITING

Cevaxin

Panama City, Panama

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood Samples, Nasal swabs

MeSH Terms

Conditions

Respiratory Tract Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Officials

• Eduardo Lopez-Medina, MD, MSc

  Centro de Estudios en Infectologia Pediatrica, CEIP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eduardo Lopez-Medina, MD, MSc

CONTACT

+57 315 0467762; eduardo.lopez@ceiponline.org

Rodrigo DeAntonio, MD

CONTACT

203 9760 / 62059692; rodrigo.deantonio@cevaxin.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Scientific Director, CEIP

Study Record Dates

• First Submitted: November 18, 2025
• First Posted: November 25, 2025
• Study Start: May 2, 2024
• Primary Completion (Estimated): May 2, 2031
• Study Completion (Estimated): December 30, 2031
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1); PA (1)