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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT06603766
Eligibility Criteria:
Inclusion Criteria:
* Newborns with documented persistent pulmonary hypertension as confirmed by echocardiography.
* Neonates born at ≥ 35 wk. gestation with a birth weight of 2.5-4 kg
* Neonates have to be connected to mechanical ventilation with an oxygenation index (OI) \>30 on two occasions at least 15 min apart.
* The echocardiogram had to show a predominant right-to-left or bidirectional shunt (through ductus arteriosus and/or foramen oval) and/or tricuspid regurgitant jet with a pressure gradient ≥ 2/3 of the systemic systolic blood pressure.
Exclusion Criteria:
* Infants of parents who refuse to give informed consent.
* Infants of mothers who receive magnesium sulfate within 48 h before labor.
* Congenital heart diseases other than patent ductus arteriosus (PDA) and foramen ovale.
* Major congenital anomalies, including congenital diaphragmatic hernia and lung hypoplasia.
* Prior need for cardiopulmonary resuscitation
* Mean arterial blood pressure (MABP) \< 35 mmHg despite therapy with volume infusions and vasoactive inotropes.
* Impaired kidney function; and prior administration of pulmonary vasodilators or prior administration of surfactant.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
3 Days
Study:
NCT06603766
Study Brief:
Protocol Section:
NCT06603766