Bronchopulmonary Dysplasia
Conditions
Interventions
Treatment:umbilical cord blood transfusion
Control group:normal saline
Sponsors
The Seventh Medical Center of PLA General Hospital
Eligibility
Sex/Gender
All
Age
No minimum to 1 Years
Inclusion criteria
Inclusion criteria: 1. Participants who are gestation age less than 28 weeks and birth weight less than 1250g, which postnatal age less than 3 d; 2. Participants who have the potential high risk of BPD great than 60% at postnatal age 3 d and 7d according to Neonatal Research Network.(https://neonatal.rti.org/index.cfm?CFID=1047681&CFTOKEN=97126457); 3. Written informed consent signed by a legal representative or a parent; 4. This control group according to the following criteria: gestational age within 3 days, birth weight within 50 g, and similar ventilator modes (mean airway pressure, fraction of inspired oxygen) within 24 hours before MNC infusion. The matched comparison group infants were not consecutive cases because of the logistical demands of matching birth weight, gestational age, respiratory severity scores, and ventilator mode.
Exclusion criteria
Exclusion criteria: 1. Participants who have the potential high risk of BPD less than 60%according to Neonatal Research Network.(https://neonatal.rti.org/index.cfm?CFID=1047681&CFTOKEN=97126457); 2. Participants who have concurrent cyanotic or acyanotic congenital heart diseases; 3. Participants who have severe respiratory tract malformation, such as ascular ring syndromepulmonary sequestration, congenital pulmonary dysplasia, congenital pulmonary cys, etc.; 4. Participants who have severe chromosome anomalies (such as Edward syndrome, Patau syndrome, Down syndrome) or severe congenital malformation (such as hydrocephalus, encephalocele) or hereditary diseases; 5. Participants who have severe congenital infection such as Herpes simplex, toxoplasmosis, rubella, syphilis, AIDS, etc.; 6. Participants who have severe active infection when C-reactive protein (CRP) > 30 mg/dl, or suffer sepsis or septic shock; 7. Participants who are going to have surgery within 72 h before/after this study hUC-MNCs administration; 8. Participants who have surfactant administration within 24 h before this hUC-MNCs administration; 9. Participants who have severe intracranial hemorrhage = grade 3 or active pneumorrhagia or active air-leak syndrome; 10. Participants who are using hormones or needing hormones within and after 7 days of hUC-MNCs administration; 11. Participants who are participating in other interventional clinical trials; 12. Participants who are considered inappropriate by the investigators or whose parents cannot provide informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| duration of oxygen therapy;duration of invasive mechanical ventilation;duration of noninvasive mechanical ventilation; | — |
Secondary
| Measure | Time frame |
|---|---|
| the first time stopping the supplemental oxygen;rate of reoxygen supplement;blood oxygen saturation;chest radiography changes;pulmonary function changes;Ventilator mode;mortality;number of hospital readmissions;preterm birth complications; | — |
Countries
China
Contacts
Public ContactZhi-Chun Feng
The Seventh Medical Center of PLA General Hospital
Outcome results
None listed