Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
600 participants
OBSERVATIONAL
2022-06-01
2030-02-28
Brief Summary
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Detailed Description
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Despite rising survival rates for premature infants, respiratory complications among these survivors are also increasing. However, there has been no clear identification of factors associated with post-prematurity respiratory diseases. Consequently, there is a growing demand among healthcare professionals in South Korea for respiratory cohorts similar to the PROP cohort in the United States and the Saitama cohort in Japan.
In the Korean Neonatal Network, data is collected on the clinical course during hospitalization and post-discharge growth and development of very low birth weight infants (weighing less than 1500g at birth) admitted to neonatal intensive care units. However, there is currently no information available on respiratory-related diseases, and investigations regarding respiratory outcomes are not being conducted. Therefore, this study aims to analyze the factors associated with respiratory outcomes in preterm survivors and to establish strategies for their prevention and treatment.
According to the research protocol, we are seeking parental consent to enroll preterm infants born before 29 weeks of gestation in participating healthcare institutions within 7 days of their birth. This enrollment will involve collecting biological materials and clinical data to establish a comprehensive database. Clinical data will primarily be obtained by reviewing medical records during the infants' hospitalization period. The assessment of long-term respiratory complications will involve conducting surveys with parents when the infants reach 4, 8, and 12 months of corrected age. Additionally, data collection at 12 and 24 months of corrected age will rely on reviewing medical records from outpatient visits to pediatric and adolescent clinics, based on examination findings and test results. In cases where obtaining in-person follow-up information is challenging, growth and developmental data may be gathered through various means, including telephone calls, text messages, emails, web surveys, and other communication methods. Web survey links will be distributed through text messages.
The primary outcome of this study is to assess the respiratory condition of preterm infants, including evaluating respiratory symptoms, the use of respiratory medications, and hospitalizations related to respiratory diseases. This assessment will be conducted at specific time points: 4, 8, 12, 18, and 24 months of corrected age.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Respiratory cohort
Preterm infants with a gestational age less than 29 weeks
Standard care for preterm infants
Standard care for preterm infants according to the institutional protocol
Interventions
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Standard care for preterm infants
Standard care for preterm infants according to the institutional protocol
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
7 Days
ALL
Yes
Sponsors
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Asan Medical Center
OTHER
Samsung Medical Center
OTHER
Seoul National University Bundang Hospital
OTHER
Chonnam National University Hospital
OTHER
Severance Hospital, Yonsei University College of Medicine
UNKNOWN
Ajou University Medical Center
UNKNOWN
Seoul National University Hospital
OTHER
Responsible Party
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Seung Han Shin
Professor
Principal Investigators
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Seung Han Shin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Children's Hospital
Locations
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Seung Han Shin
Seoul, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Seung Han Shin, MD, PhD
Role: primary
Gyeong Eun Yeom, MD
Role: backup
Baek Sup Shin, MD
Role: backup
Other Identifiers
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EPRO
Identifier Type: -
Identifier Source: org_study_id