bronchopulmonary dysplasia
Conditions
Interventions
test group:Mesenchymal stem cell infusion
Control group:Cord blood mononuclear cell transfusion
Sponsors
Army Medical Center of PLA(Daping Hospital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent signed by the legal representative or parents; 2. Gestational age <32 weeks, weight <1500 g, no gender limit; 3. Meet the diagnostic criteria for moderate to severe BPD established by the US NICHD in 2001; 4. Need for breathing support.
Exclusion criteria
Exclusion criteria: 1. Gestational age> 32 weeks or weight = 1500g or no need for breathing support ; 2. Although mechanical ventilation or oxygen is required, there is no dyspnea or signs of lung imaging changes related to BPD (such as central apnea or diaphragm palsy); 3. Severe congenital heart disease, except for patent ductus arteriosus and atrial septal defect and ventricular septal defect with defects less than 5mm; 4. Important laboratory tests (liver and kidney function tests, heart markers tests, hematology and immune tests, urinalysis, etc.) abnormal participants are more than three times the normal value; 5. Children with severe pulmonary hypertension confirmed by cardiac ultrasound at the time of evaluation; 6. Participants with severe respiratory malformations, such as Pierre-Robin syndrome, tracheobronchomalacia, vascular ring syndrome, congenital tracheal stenosis, tracheoesophageal fistula, emphysema, pulmonary sequestration, congenital lung dysplasia, congenital Pulmonary cysts, congenital spasms, etc. 7. Children with severe chromosomal abnormalities (such as Edward's syndrome, Patau syndrome, Down syndrome) or severe congenital abnormalities (such as hydrocephalus, encephalocele) or genetic diseases; 8. Children with severe congenital infections, such as herpes simplex, toxoplasmosis, rubella, syphilis, AIDS, etc. 9. Children with severe active infection or sepsis or septic shock when C-reactive protein (CRP)> 30 mg/dL; 10. Children who will undergo surgery within 72 hours before and after this study; 11.Children who have been administered surfactant within 24 hours before the MSCs; 12. Children with severe intracranial hemorrhage = Grade 3 or active blood or active air leak syndrome; 13. Within 7 days after the administration of MSCs and children who use hormones or need hormones afterwards; 14. Children who participate in other interventional clinical trials; 15. The investigator considers inappropriate children or the children whose parents cannot provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serious adverse event ;Moderate to severe BPD ; | — |
Secondary
| Measure | Time frame |
|---|---|
| vital signs;hematology index;tumorigenic or teratogenic event ;oxygen time;in-hospital days;PaO2;deoxidation ratio;readmission rate;mortality rate;inflammatory factors ; | — |
Countries
China
Contacts
Public ContactHuzhangxue
Army Medical Center of PLA(Daping Hospital)
Outcome results
None listed