Actively Recruiting
Multicenter Cohort for Respiratory Outcome of Preterm Infants
Led by Seoul National University Hospital · Updated on 2024-12-10
600
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Seoul National University Hospital
Lead Sponsor
A
Asan Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the respiratory outcomes of preterm infants born before 29 weeks of gestation, focusing on how various factors affect their lung function and long-term health. The study also looks at growth and developmental progress in these infants, aiming to improve prevention and treatment of chronic respiratory diseases. This observational research collects detailed clinical data and biological samples to better understand risks and outcomes. Participants are preterm infants enrolled within 7 days of birth at participating hospitals. The study involves reviewing medical records during hospitalization and following infants through 24 months corrected age. Surveys are conducted with parents at 4, 8, and 12 months corrected age, and outpatient visit records are analyzed at 12 and 24 months. When direct follow-up is challenging, information may be collected via phone, text, email, or web surveys. Throughout the study, researchers assess respiratory symptoms, medication use, hospitalizations, growth, and developmental milestones. The main outcome is the evaluation of postprematurity respiratory disease at 12 months corrected age. Additional assessments include growth and development at 24 months and long-term respiratory outcomes at 6 years. The study aims to create a comprehensive database to support better care strategies for these vulnerable infants.
CONDITIONS
Brief Title
Extremely Preterm Respiratory Outcome Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Infants born at gestational age less than 29 weeks
- Parental consent obtained within 7 days of birth
You will not qualify if you...
- Death within 3 days of birth
- Severe structural heart defects
- Structural abnormalities in the upper airway, lungs, or chest
- Congenital anomalies that may impact cardiopulmonary function
- Follow-up is difficult until 24 months of age
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days after birth
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit
Duration - Duration of initial hospitalization
Participants are observed during hospitalization with clinical data and biological materials collected to establish a comprehensive database.
Data collection through medical record review during hospital stay
Duration - From 4 to 12 months of corrected age
Participants' respiratory condition is assessed through surveys with parents at multiple corrected ages to track respiratory symptoms, medication use, and hospitalizations.
Surveys conducted at 4, 8, and 12 months of corrected age
Duration - Up to 24 months of corrected age and beyond for long-term outcomes
Participants' growth, development, and respiratory outcomes are monitored through medical record reviews and various communication methods up to 24 months and beyond.
Medical record reviews at 12 and 24 months; additional data collected via phone, text, email, or web surveys
Trial Site Locations
Total: 1 location
1
Seung Han Shin
Seoul, South Korea, 110-744
Actively Recruiting
Research Team
S
Seung Han Shin, MD, PhD
G
Gyeong Eun Yeom, 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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here