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 @ 10:22 PM
Ignite Modification Date:
2025-12-24 @ 10:22 PM
NCT ID:
NCT06512935
Eligibility Criteria:
Inclusion Criteria:
Preterm infants with recovering respiratory distress syndrome (RDS) who were born at a gestational age \< 34 weeks and are receiving respiratory support via conventional mechanical ventilation or on HFJV.
* Post-natal age \> 7 days and less than 1 month (outside golden week protocol)
* Gestational age ≥ 21 weeks and ≤ 34 week
* Infants with written informed consent obtained from legal guardian
Exclusion Criteria:
* Blood culture-positive sepsis
* Congenital anomalies affecting respiration
* Cyanotic or ductal-dependent congenital heart disease
* Newborns who are considered too unstable for study enrolment per neonatology attending
* Newborns on pressors or steroids for maintaining cardiac output
* Non-invasive ventilation or newborn with significant BPD (bronchopulmonary dysplasia) with pulmonary hypertension (HTN)
* Open skin wounds or abrasions on the chest wall.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
7 Days
Maximum Age:
30 Days
Study:
NCT06512935
Study Brief:
Protocol Section:
NCT06512935