Extremely Preterm Respiratory Outcome Cohort
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 7
SponsorSeoul National University Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Standard care for preterm infants
Other interventionStandard care for preterm infants according to the institutional protocol
Treatment groups
600 Participants
are divided into 1 treatment groupGroup A: Respiratory cohort1 intervention
Trial outcomes
Primary outcomes
1
Postprematurity respiratory disease
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
Time frame
12 months of corrected ageSecondary outcomes
1
Growth assessment
Weight z-score for sex and age based on WHO growth curve
Time frame
at 24 months of corrected age2
Any delay in developmental scale evaluation
Any delay (\<85) in Bayley Scales of Infant and Toddler Development of 1. Mental Development Index or Psychomotor Development Index in Edition II 2. Cognitive, Language or Motor domain in Edition III
Time frame
at 24 months of corrected age3
Long-term respiratory outcome
FEV1 (forced expiratory volume in one second) in pulmonary function test
Time frame
at 6 years of corrected ageSponsors and contacts
Click on the lead sponsor to view all of their trials.
Seoul National University Hospital
Lead sponsor
Asan Medical Center
Collaborator
Samsung Medical Center
Collaborator
Seoul National University Bundang Hospital
Collaborator
Chonnam National University Hospital
Collaborator
Severance Hospital, Yonsei University College of Medicine
Collaborator
Ajou University Medical Center
Collaborator
Source ClinicalTrials.gov