Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT06471556
Eligibility Criteria:
Inclusion Criteria:
* Infant aged under 12 months
* NEHI diagnosis based on:
* The recently validated clinical Liptzin score ≥7/10 associated with a suggestive thoracic CT pattern with ground glass opacities confined to middle lobe, lingula, and paramediastinal lung areas OR
* a clinical and thoracic CT suspicion and a lung biopsy showing an increased number of neuroendocrine cells in the epithelial airways area (at least one bronchiole with at least 10% of neuroendocrine cells)
* Oxygen requirement (awake and/or asleep) based on the usual pediatric recommendations (see section 4.1.1)
* Followed in one of the RespiRare participating centers
* Written informed consent of the holder(s) of its legal representative at the inclusion
Exclusion Criteria:
* Other cause of chILD assessed by lab biology tests, genetic analysis for surfactant genes (if available), bronchoalveolar lavage, and/or lung biopsy.
* Patient treated with IV methylprednisolone pulses before (any time)
* Diabetes
* Uncontrolled arterial hypertension
* Absence of Health care insurance
* Ongoing infection
* Immunization with a live attenuated vaccine within the past two weeks
* Long term treatment with Azithromycin and/or Hydroxychloroquine
* Patients already included in an interventional study (RIPH1, clinical investigation or clinical trial)
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
12 Years
Study:
NCT06471556
Study Brief:
Protocol Section:
NCT06471556