Bronchopulmonary Dysplasia, Neonatal Death, Premature
Conditions
Keywords
prevention, Bronchopulmonary Dysplasia, preterm, cord blood mononuclear cells
Brief summary
Rationale: Pre-clinical animal studies provide robust evidence regarding the beneficial effect of cord blood-derived mononuclear cells (MNCs) for experimental bronchopulmonary dysplasia (BPD). This single-center, non-randomized, controlled, blinded trial assessed the effect of a single intravenous infusion of autologous cord blood MNCs (ACBMNCs) in preventing BPD in very preterm neonates, a high-risk population.
Interventions
Autologous Umbilical Cord Blood Mononuclear Cells Therapy in preterm for prevention of infection
Sponsors
Guangdong Women and Children Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
0 Weeks to 32 Weeks
Healthy volunteers
No
Inclusion criteria
(1) born at the study hospital; (2) singleton birth; (3) GA \<32 weeks; (4) free of severe congenital anomalies or genetic syndromes; (5) without clinical chorioamnionitis; (6) the mother was negative for hepatitis B (HBsAg and/or HBeAg), hepatitis C (anti-HCV), syphilis, HIV (anti-HIV-1 and -2), and IgM against cytomegalovirus, rubella, toxoplasma, and herpes simplex viruses; (7) consent was obtained from the parents or guardians; and (8) after processing, UCB cells were available.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| bronchopulmonary dysplasia at 36 weeks of postmenstrual age or the discharge home | 36 weeks of postmenstrual age or the discharge | bronchopulmonary dysplasia rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of patients with severe BPD in survivors | 36 weeks of postmenstrual age or the discharge | severe BPD in survivors |
| number of patients died before discharge from hospital | before discharge from hospital | mortality before discharge from hospital |
| the duration of mechanical ventilation | before discharge from hospital | Other outcomes |
Countries
China
Outcome results
None listed