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 @ 2:10 AM
Ignite Modification Date:
2025-12-25 @ 2:10 AM
NCT ID:
NCT03607760
Eligibility Criteria:
Inclusion Criteria:
1\. ECMO group:
1. Oxygenation Index \> 40 for \>4 hours
2. Failure to wean from 100% oxygen despite prolonged (\> 48h) maximal medical therapy or persistent episodes of decompensation
3. Severe hypoxic respiratory failure with acute decompensation (PaO2 \<40) unresponsive to intervention
4. Severe pulmonary hypertension with evidence of right ventricular dysfunction and/or left ventricular dysfunction. The pulmonary artery pressure \> 60mmHg evaluated by the Echo, arterial duct keeps open and the blood flow was either by-level shunt or completely shunt from right side to left side.
2\. Non-ECMO group:
1. Oxygenation Index \> 16 and reach the Montreux definition of severe respiratory distress syndrome
2. Vasoactive-inotropic score (VIS) ≥ 40 \[VIS=dopamine dose (μg/kg/min)×1 + dobutamine dose (μg/kg/min)×1 + milrinone dose (μg/kg/min)×10 + amrinone dose (μg/kg/min)×10 + epinephrine dose (μg/kg/min)×100 + isoprenaline dose (μg/kg/min)×100\]
Exclusion Criteria:
1. Gestational age \< 36 weeks, birth weight \< 2 kg, day post-birth \> 28 days.
2. lethal chromosomal disorder (includes trisomy 13, 18 but not 21) or any other lethal anomaly
3. irreversible brain damage
4. uncontrolled bleeding
5. Grade III or greater intraventricular hemorrhage
6. ventilator days ≥ 15 days.
Sex:
ALL
Minimum Age:
1 Hour
Maximum Age:
1 Month
Study:
NCT03607760
Study Brief:
Protocol Section:
NCT03607760