ClinicalTrials.gg
RecruitingNCT07249996MINERVALUpdated Nov 25, 2025

Respiratory Infections in Young Children

An observational study in Respiratory Tract Infections (RTI), Lower Respiratory Tract Infection (LRTI) and Viral Infections, sponsored by Eduardo Lopez -Medina. Recruiting at 2 sites in 2 countries. Open to participants aged Up to 29 Days, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-25.

Sponsored by Eduardo Lopez -Medina · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,088
Ages
Up to 29 Days
Sex
All
01

Study 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.

Read the detailed description

Respiratory tract infections (RTIs) remain one of the most common causes of illness and death in young children, despite advances in vaccination and health programs. In children under five years of age, RTIs cause significant morbidity, social costs, and long-term health consequences. The clinical spectrum of RTI ranges from mild upper infections to severe lower respiratory tract infections (LRTIs) such as bronchiolitis and pneumonia. Viruses are the leading cause, especially in the first two years of life. However, in Latin America, there is limited information about how often RTIs occur, what viruses or bacteria are responsible, and how severe these infections are in community settings. Most existing data come from hospitalized cases, which underestimate the real disease burden.

To address this gap, researchers launched the MINERVAL study, a multicenter, prospective birth cohort conducted in Cali, Colombia, and Panamá City, Panamá. The study began in May 2024 and follows children from birth to five years of age to better understand the epidemiology, etiology, and consequences of RTIs. A total of 436 newborns have been enrolled as of February 2025. This population-based cohort is followed by active surveillance twice a week using a phone app or calls, with in-person visits during RTI episodes and routine visits every six months in the first two years of life. From ages two to five, children continue follow-up every six months to assess long-term outcomes.

The study has four main objectives: (1) to determine the incidence, etiology, and seasonality of RTIs in children aged 0-2 years; (2) to assess the pathogen-specific burden of infections caused by viruses such as RSV, hMPV, influenza, SARS-CoV-2, and others across outpatient and inpatient settings; (3) to evaluate long-term respiratory sequelae of LRTIs during early life and their association with chronic respiratory illness by age five; and (4) to analyze viral-bacterial interactions, focusing on how pneumococcal bacterial loads and immune responses influence disease progression.

Preliminary data from 436 participants show 222 RTI episodes, including 42 LRTIs. The cumulative incidence of RTI was 40% at 100 days and 64.8% at 250 days. For LRTIs, incidence was 8.9% at 100 days and 12.2% at 250 days. Among LRTIs, 82.9% were mild, 14.6% moderate, and 2.4% severe. More than half of LRTI episodes required hospitalization, and 14.3% required intensive care. Samples have been collected from 91% of episodes for laboratory analysis.

These findings confirm the feasibility of long-term active surveillance in this cohort and the high frequency of early-life respiratory infections. The continued study will provide critical insights into the incidence, mechanisms, and long-term health consequences of RTIs in Latin American children, supporting the development of new preventive and therapeutic strategies.

02

Conditions studied

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

Keywords

  • Birth Cohort Study
  • Respiratory Tract Infection (RTI)
  • Children
03

In context

Respiratory Tract Infections

751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.

This study's planned enrollment of 1,088 is above the median of 350 across 184 observational studies indexed under Respiratory Tract Infections.

Browse Respiratory Tract Infections studies →

Lead sponsor

This is the only study on the registry with Eduardo Lopez -Medina as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 29 Days
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 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

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).
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,088 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • • 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.

06

What researchers measure

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.

    Time frame: From enrollment, up to 2 years of age.

Secondary outcomes

  1. 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

    Time frame: From enrollment, up to 2 years of age

  2. 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

    Time frame: From recruitment, up to 2 years of age

  3. Pneumococcal bacterial load and Host immune response

    Disease severity according to pneumococcal bacterial loads and whole blood transcriptome analysis.

    Time frame: From recruitment, up to 2 years of age

Other outcomes

  1. 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

    Time frame: From recruitment to study completion at 5 years

07

Study locations

2 of 2 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2024 (actual). Primary completion is estimated for May 2031, 84 months after the start.

Of 66 non-industry observational studies under Respiratory Tract Infections, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 48. This study's planned 84 months is above that.

Counting every sponsor, half of 85 studies reached it within 18 months; a quarter within 8 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 18, 2025
First posted
Nov 25, 2025
StartActual
May 2, 2024
Primary completionEst.
May 2, 2031
CompletionEst.
Dec 30, 2031
Last update
Nov 25, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Nov 25, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07249996
Lead sponsor
Eduardo Lopez -Medina
Responsible party
Eduardo Lopez -Medina (Scientific Director, CEIP, Centro de Estudios en Infectogía Pediatrica) — Sponsor-investigator
First posted
Nov 25, 2025
Start date
May 2, 2024
Primary completion
May 2, 2031 (estimated)
Completion
Dec 30, 2031 (estimated)
Last update
Nov 25, 2025

Study contacts

Eduardo Lopez-Medina, MD, MSc
Contact
eduardo.lopez@ceiponline.org
+57 315 0467762
Rodrigo DeAntonio, MD
Contact
rodrigo.deantonio@cevaxin.com
203 9760 / 62059692
Eduardo Lopez-Medina, MD, MSc
principal investigator · Centro de Estudios en Infectologia Pediatrica, CEIP

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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