Extremely Preterm Respiratory Outcome Cohort

NCT06726226 | Recruiting DMC

• 1 other identifier: EPRO
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Infant, Premature; Respiratory Disease

Outcome Measures

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

  12 months of corrected age

Secondary Outcomes (3)

• Growth assessment

  at 24 months of corrected age

• Any delay in developmental scale evaluation

  at 24 months of corrected age

• Long-term respiratory outcome

  at 6 years of corrected age

Study Arms (1)

Respiratory cohort

Preterm infants with a gestational age less than 29 weeks

Other: Standard care for preterm infants

Interventions

Standard care for preterm infants OTHER

Standard care for preterm infants according to the institutional protocol

Respiratory cohort

Eligibility Criteria

• Age: Up to 7 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• Infants born at gestational age less than 29 weeks with cohort consent obtained within 7 days of birth

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• 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

Study Sites (1)

Seung Han Shin

Seoul, 110-744, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1. Transtracheal aspirate Collection Timing: Immediately after registration, 3(±1) days after the first collection, 14(±2) days after birth, and 28(±2) days after birth. 2. Urine Collection Timing: Immediately after registration, 3(±1) days after the first collection, 14(±2) days after birth, and 28(±2) days after birth.

MeSH Terms

Conditions

Premature Birth; Respiration Disorders

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Seung Han Shin, MD, PhD

  Seoul National University Children's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seung Han Shin, MD, PhD

CONTACT

+82-02-2072-7230; revival421@snu.ac.kr

Gyeong Eun Yeom, MD

CONTACT

+82-02-2072-0083; minwoeun@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 16, 2024
• First Posted: December 10, 2024
• Study Start: June 1, 2022
• Primary Completion (Estimated): February 28, 2030
• Study Completion (Estimated): February 28, 2030
• Last Updated: December 10, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)