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:
2025-12-25 @ 12:36 AM
Ignite Modification Date:
2025-12-25 @ 12:36 AM
NCT ID:
NCT04938167
Eligibility Criteria:
Inclusion Criteria:
* Corrected gestational age (postmenstrual age) \> 34 6/7 weeks
* postnatal age ≤ 28 d
* on respiratory support with invasive mechanical ventilation, non-invasive ventilation, CPAP or high flow nasal cannula (defined as flow rates ≥ 2 LPM with a humidifier), inspired oxygen concentration, FiO2 ≥ 0.3
* and echocardiography shows any finding suggestive of PH (or score \> 0 for PH in table 2).
* Infants with congenital diaphragmatic hernia (CDH), Down syndrome, hypoxic ischemic encephalopathy (HIE) on therapeutic hypothermia and patent ductus arteriosus (PDA), patent foramen ovale/atrial septal defect (PFO/ASD) and ventricular septal defect (VSD) (single or multiple) \< 2 mm can be included in the study.
Exclusion Criteria:
* \< 32 weeks gestation at birth (31 6/7 or lower)
* Weight \< 2000 g at the time of enrollment
* Severe HRF with OI \> 35 or SpO2 \< 75% on FiO2 = 1.0 on mechanical ventilation for \> 60 minutes in spite of correction of reversible factors such as pneumothorax
* A condition or congenital anomaly known to be lethal (high likelihood of death during infancy) - e.g., trisomy 18 or trisomy 13
* Congenital heart disease other than ASD/PFO, PDA or VSD (single or multiple defects) \< 2 mm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Days
Maximum Age:
28 Days
Study:
NCT04938167
Study Brief:
Protocol Section:
NCT04938167