Clinical Trial: A Nationwide Study on Severe Respiratory Syncytial Virus Infection in Children with Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases (Japan)

Tokyo, June 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061307) titled 'A Nationwide Study on Severe Respiratory Syncytial Virus Infection in Children with Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases' on June 1.

Study Type: Observational

Primary Sponsor: Institute - Institute of Science Tokyo

Condition: Condition - Pulmonary Hypoplasia, Airway Stenosis, Esophageal Atresia, Inborn Errors of Metabolism, and Neuromuscular Diseases Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate changes in the rate of hospitalization and severity of respiratory syncytial virus (RSV) infection among children under 5 years of age with five disease groups (pulmonary hypoplasia, airway stenosis, esophageal atresia, inborn errors of metabolism, and neuromuscular diseases) newly approved for palivizumab prophylaxis in April 2024. Basic objectives2 - Efficacy

Eligibility: Age-lower limit - 1 days-old

Gender - Male and Female Key inclusion criteria - Children who have medical records from April 2022 to March 2026 and were between 0 and 5 years old at any point during that period, and who have one of the following five categories of diseases: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, congenital metabolic disorders, and neuromuscular diseases. Key exclusion criteria - Children aged 5 years or older with any of the following five categories of diseases: pulmonary hypoplasia, airway stenosis, congenital esophageal atresia, congenital metabolic disorders, and neuromuscular diseases. Target Size - 2100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 04 Month 01 Day Anticipated trial start date - 2026 Year 06 Month 01 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069474

Disclaimer: Curated by HT Syndication.