BPD Clinical Trial
Official title:
Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates: a Placebo-controlled Randomized Multicenter Trial
This is the first and largest randomized, controlled, blinded trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for BPD or death. The results of this trial will provide valuable clinical evidence for recommendations on the management of BPD in extremely preterm infants. In this prospective, randomized controlled double-blind multi-center clinical trial, 140 extremely preterm neonates less than 28 weeks are randomly assigned to receive intravenous autologous cord blood mononuclear cells infusion (targeted dose of 5×107cells/kg but no less than 1×107cells/kg) or placebo ( normal saline) within 24 hours after birth in a 1:1 ratio using a central randomization system. The primary outcome is survival without bronchopulmonary dysplasia at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include mortality rate, BPD severity, other common preterm complication rate, respiratory support duration, the length and cost of hospitalization and long term outcomes after two years follow up post infusion.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2023 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 0 Weeks to 28 Weeks |
Eligibility | Inclusion Criteria: Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB). Exclusion Criteria: Those infants are excluded if they were 1. with severe congenital abnormalities; 2.with maternal clinical chorioamnionitis 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus. |
Country | Name | City | State |
---|---|---|---|
China | Ren Xuejun | Dongguan | Guangdong |
China | Jie Yang | Guangzhou | Guangdong |
Lead Sponsor | Collaborator |
---|---|
Guangdong Women and Children Hospital | Dongguan Women and Children Hospital, Foshan Fuxing Chancheng Central Hospital, Foshan Women and Children Hospital, Guangdong Cord Blood Bank, Guangzhou Huadu Women and Children Hospital, Hexian Memorial Affiliated Hospital of Southern Medical University, Heyuan Women and Children Hospital, Huangdu Distric Women and Children Hospital, Huizhou first Women and Children Hospital, Huizhou second Women and Children Hospital, Longgang Distric Women and Children Hospital,Shenzhen, Shunde Women and Children Hospital, Zhongshan Boai Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | frequency of bronchopulmonary dysplasia or death | The frequency of bronchopulmonary dysplasia or death at 36 weeks of postmenstrual age or discharge home whichever comes first. | 36 weeks of postmenstrual age or discharge home whichever comes first. | |
Secondary | mortality | The mortality rate.
Incidence of other preterm complications including intraventricular hemorrhage (IVH), periventricular leukomalacia (PVL), necrotizing enterocolitis (NEC), retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), ventilation-associated pneumonia (VAP), late onset sepsis (LOS) and anemia . Duration of hospitalization. Duration of mechanical ventilation and oxygen therapy The frequency of re-intubation. The time (days) return to BW. |
36 weeks of postmenstrual age or the discharge |
Status | Clinical Trial | Phase | |
---|---|---|---|
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