Infant, PrematureNCT06726226
Extremely Preterm Respiratory Outcome Cohort
An observational study of Infant, Premature and Respiratory Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary… Read more about this study
- Who is it for?
- Ages Up to 7 daysHealthy volunteers can take part
- Conditions the study is for
- Infant, Premature, Respiratory Disease
- How many people
- 600 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jun 2022to 28 Feb 2030
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 7 days
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study is a multicenter cohort study conducted by a total of 7 institutions (Seoul National University Hospital, Severance Hospital, Asan Medical center, Samsung Medical Hospital, Ajou University Hospital, Bundang Seoul National University Hospital, Chonnam National University Hospital) jointly. It includes all preterm infants born at these hospitals from March 2022 to December 2024, who are born at a gestational age of less than 29 weeks and are admitted to the neonatal intensive care unit.
Who may be able to join
- Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Seung Han Shin
Seoul, 110-744
Seung Han Shin, MD, PhD, +82220727230, revival421@snu.ac.kr
Gyeong Eun Yeom, MD
About this study
Official title: Multicenter Cohort for Respiratory Outcome of Preterm Infants
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.
Read the detailed description
The purpose of this study is to identify various neonatal and perinatal factors that influence the respiratory outcomes of premature infants born at gestational ages less than 29 weeks. Ultimately, the study aims to improve the prevention and treatment of chronic respiratory diseases in these infants by detecting and treating high-risk groups early. Specifically, it seeks to identify factors related to chronic respiratory diseases through the analysis of neonatal specimens.
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
- Infant, Premature, Respiratory Disease
- Being tested
- Standard care for preterm infants
- Medical subject headings
- Premature Birth, Respiration Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard care for preterm infantsOther
Standard care for preterm infants according to the institutional protocol
| Study group | Role | What they receive |
|---|---|---|
| Respiratory cohort | Preterm infants with a gestational age less than 29 weeks Receives: Other: Standard care for preterm infants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprematurity respiratory disease
- Severe
- ≥2 respiratory hospitalizations,
- home supplemental O2 after 3 months or any home mechanical ventilation,
- systemic steroid exposure or pulmonary vasodilators, or symptoms despite -inhaled corticosteroid use
- Mild to moderate
- one hospitalization
- home oxygen <3 months corrected age or tracheostomy without ventilation,
- any inhaled corticosteroid or bronchodilator exposure, or symptoms in ≥2 questionnaires
- No/minimal - all other cases
- Respiratory medications 2. Hospitalizations for cardiopulmonary cause 3. Coughing, wheezing, or other respiratory symptoms 4. Home technology dependence
Measured: 12 months of corrected age
Secondary outcomes (3)
Growth assessment
Weight z-score for sex and age based on WHO growth curve
Measured: at 24 months of corrected age
Any delay in developmental scale evaluation
Any delay (<85) in Bayley Scales of Infant and Toddler Development of
- Mental Development Index or Psychomotor Development Index in Edition II
- Cognitive, Language or Motor domain in Edition III
Measured: at 24 months of corrected age
Long-term respiratory outcome
FEV1 (forced expiratory volume in one second) in pulmonary function test
Measured: at 6 years of corrected age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start1 Jun 2022
- Primary completion28 Feb 2030 (estimated)
- Study completion28 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infant, PrematureStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 600 participants (estimated)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Chonnam National University Hospital, Severance Hospital, Yonsei University College of Medicine, Ajou University Medical Center
- Responsible party
- Principal investigator, Seung Han Shin, Seoul National University Hospital
- Investigators
- Seung Han Shin, MD, PhD, Principal investigator, Seoul National University Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06726226
- Sponsor's protocol ID
- EPRO
- Status last verified
- Dec 2024
- First submitted
- 16 Jan 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Cohort for Respiratory Outcome of Preterm Infants
- ClinicalTrials.gov ID
- NCT06726226
- Acronym / sponsor ID
- EPRO
- Conditions
- Infant, Premature, Respiratory Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Asan Medical Center, Samsung Medical Center, Seoul National University Bundang Hospital, Chonnam National University Hospital, Severance Hospital, Yonsei University College of Medicine, Ajou University Medical Center
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 28 Feb 2030 (estimated)
- Study completion
- 28 Feb 2030 (estimated)
- First posted
- 10 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the respiratory outcomes of preterm infants born at gestational ages less than 29 weeks, spanning from birth to 24 months corrected age. It delves into the intricacies of respiratory function impairment attributable to diverse factors, such as respiratory distress syndrome, bronchopulmonary dysplasia, postnatal corticosteroids, ventilatory support, as well as nutritional aspect during NICU stay. Furthermore, it scrutinizes the incidence of chronic respiratory diseases stemming from these conditions, assessing their long-term impact on respiratory prognosis post-discharge. In addition to respiratory aspects, the research extends its focus to the growth and developmental outcomes of preterm infants. By synthesizing these multifaceted elements, the study aspires to enhance current treatments and preventative measures for respiratory conditions in preterm infants.
Detailed description
The purpose of this study is to identify various neonatal and perinatal factors that influence the respiratory outcomes of premature infants born at gestational ages less than 29 weeks. Ultimately, the study aims to improve the prevention and treatment of chronic respiratory diseases in these infants by detecting and treating high-risk groups early. Specifically, it seeks to identify factors related to chronic respiratory diseases through the analysis of neonatal specimens.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Respiratory cohort | – | Other: Standard care for preterm infantsPreterm infants with a gestational age less than 29 weeks |
Who may qualify
- Ages
- Up to 7 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study is a multicenter cohort study conducted by a total of 7 institutions (Seoul National University Hospital, Severance Hospital, Asan Medical center, Samsung Medical Hospital, Ajou University Hospital, Bundang Seoul National University Hospital, Chonnam National University Hospital) jointly. It includes all preterm infants born at these hospitals from March 2022 to December 2024, who are born at a gestational age of less than 29 weeks and are admitted to the neonatal intensive care unit.
Key inclusion criteria (1 listed)
- Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard care for preterm infantsStandard care for preterm infants according to the institutional protocol | Other | Respiratory cohort |
Primary outcome
Postprematurity respiratory disease
Time frame: 12 months of corrected age
1. Severe * ≥2 respiratory hospitalizations, * home supplemental O2 after 3 months or any home mechanical ventilation, * systemic steroid exposure or pulmonary vasodilators, or symptoms despite -inhaled corticosteroid use 2. Mild to moderate * one hospitalization * home oxygen <3 months corrected age or tracheostomy without ventilation, * any inhaled corticosteroid or bronchodilator exposure, or symptoms in ≥2 questionnaires 3. No/minimal - all other cases 1. Respiratory medications 2. Hospitalizations for cardiopulmonary cause 3. Coughing, wheezing, or other respiratory symptoms 4. Home technology dependence
3 secondary outcomes
Growth assessment
Time frame: at 24 months of corrected age
Any delay in developmental scale evaluation
Time frame: at 24 months of corrected age
Long-term respiratory outcome
Time frame: at 6 years of corrected age
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Seung Han Shin, MD, PhD principal investigator
Seoul National University Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infant, Premature and Respiratory Disease, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seung Han Shin, MD, PhD (+82-02-2072-7230, revival421@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprematurity respiratory disease (time frame: 12 months of corrected age). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2024; AzTrials last refreshed its copy on 29 Oct 2026.