Ireland
--:--IST
Recruiting Observational

Extremely Preterm Respiratory Outcome Cohort

NCT06726226 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2022-06-01
Last updated
2024-12-10

Condition(s) studied

Infant, PrematureRespiratory Disease

Investigational drug(s) / intervention(s)

Standard care for preterm infants

Standard care for preterm infants: Standard care for preterm infants according to the institutional protocol

Study 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 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

Sex
ALL
Min age
—
Max age
7 Days
Healthy volunteers
Accepted
Inclusion Criteria: * Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth Exclusion Criteria: * 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

Primary outcome measure(s)

  • Postprematurity respiratory disease — 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

Trial sites (1)

FacilityCityRegionStatus
Seung Han Shin Seoul South Korea Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06726226 on ClinicalTrials.gov ↗ ← All trials in South Korea