PNEUMOSTEM® for Improving Respiratory Outcomes in Very Premature Infants Diagnosed With Early Pulmonary Arterial Hypertension

Korábbi kezelés

• Those who underwent surgery within 72 hours before or after administration of the investigational cell product, or those for whom surgery is anticipated
• Those who received surfactant within 24 hours prior to administration of the investigattional cell product
• Those with severe sepsis or shock due to active infection not adequately treated with antibiotics

Más betegség

• Those witth cyanotic congenital heart defects or acyanotic congenital heart defects causing heart failure, excluding patent ductus arteriosus in premature infatns
• Those with severe pulmonary malformations such as congenital diaphragmatic hernia or congenital cystic lung disease
• Those with chromosomal abnormalities accompanied by severe malformations(such as Edwards syndrome, Patau syndrome, Down syndrome, etc.) and severe congenital malformations(such as hydrocephalus, encephalocele, etc.)
• Those with severe congenital infectious diseases(such as herpes, toxoplasmosis, rubella, syphilis, AIDS, etc.)
• Those who have a history of participation in other advanced regenerative medicine clinical studies or clinical trials

Egyéb

• Others deemed inappropriate by tthe investigator to participate in this advanced regenerative medicine clinical study

• Premature infants within 2 weeks of birth with a gestational age of 28 weeks or less or birth weight of less than 1,250g who require continuous invasive mechanical ventilation
• When diagnosed with early pulmonary arterial hypertension satisfying condition ① or ② up to 14 days after birth:
  • When on or more of the following abnormal findings are present on echocardiography performed between 4 and 14 days after birth (findings at 1-3 days after birth correspond to early neonatal transition):
  • Sytemic or suprasystemic pulmonary artery pressure >40mmHg(based on peak Doppler velocity of tricuspid regurgitation)
  • Right-to-left or bidirectional shunt through patent ductus arteriosus, foramen ovale, or atrial septal defect
  • Flattened interventricular septum or D-shaped left ventricle at end systole ② When receiving nitric oxide(NO) inhalation therapy for persistent pulmonary hypertension of the newborn(PPHN) within 3 days after birth