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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT01389856
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent by the parent(s) or the legal representative(s).
2. Term and near term newborns (gestational age \> 34 weeks).
3. Post natal age ≥ 12 hours and \< 7 days.
4. Weight at birth ≥ 2,000 g.
5. Idiopathic PPHN or PPHN due to parenchymal lung disease
6. Documented diagnosis of pulmonary hypertension (PH) confirmed by echocardiography.
7. Need for continued inhaled nitric oxide (iNO) at a dose \> 10ppm after at least 4 hours of continuous iNO treatment.
8. Two oxygenation index (OI) values ≥ 12 taken at least 30 minutes apart, in the 12 hours prior to randomization and while the patient is receiving iNO treatment.
9. Mechanical ventilation with fraction of inspired oxygen (FiO2) ≥ 50% at randomization.
Exclusion Criteria:
1. PH associated with conditions other than PPHN.
2. Immediate need for cardiac resuscitation or extracorporeal membrane oxygenation (ECMO).
3. Lethal congenital anomalies.
4. Congenital Diaphragmatic Hernia.
5. Significant structural cardiac anomalies.
6. Medically significant pneumothorax.
7. Active seizures.
8. Expected duration of mechanical ventilation of less than 48 hours.
9. Mean systemic blood pressure \< 35 mmHg despite therapy with volume infusions and cardiotonic support.
10. Hepatic failure or all conditions with alanine aminotransferase (ALT) values \> 2 x upper limit of normal (ULN).
11. Renal function impairment such as serum creatinine \> 3 x ULN or anuria.
12. Known intracranial hemorrhage grade III or IV.
13. Either hemoglobin or hematocrit level \< 75% of the lower limit of normal (LLN).
14. Thrombocytopenia (platelet count \< 50,000 cells /µL).
15. Leukopenia (WBC \< 2,500 cells/ µL).
16. Any condition precluding the use of a nasogastric/orogastric tube.
17. Administration of prohibited medication prior to randomization.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Hours
Maximum Age:
7 Days
Study:
NCT01389856
Study Brief:
Protocol Section:
NCT01389856