Using cord blood cells to prevent lung disease in very premature babies
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 study is testing if giving very premature babies their own cord blood cells can help prevent lung disease and improve their chances of survival.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 0 Weeks to 28 Weeks |
| Sex | All |
| Sponsor | Guangdong Women and Children Hospital Academic / other |
| Locations | 2 sites (Dongguan, Guangdong and 1 other locations) |
| Trial ID | NCT04440670 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of infusing autologous cord blood mononuclear cells in extremely preterm neonates to prevent bronchopulmonary dysplasia (BPD) or death. In a randomized, controlled, double-blind design, 140 infants born before 28 weeks of gestation will receive either the cell infusion or a placebo within 24 hours after birth. The primary outcome is survival without BPD at 36 weeks of postmenstrual age or discharge home, while secondary outcomes include mortality rates and the severity of BPD. The trial aims to provide critical evidence for managing BPD in this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates for this study are infants born at less than 28 weeks of gestation who have available umbilical cord blood.
Not a fit: Patients with severe congenital abnormalities or maternal infections such as HIV or hepatitis are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of bronchopulmonary dysplasia and improve survival rates in extremely preterm infants.
How similar studies have performed: Previous studies have indicated that cord blood cell infusions may reduce respiratory support duration in preterm infants, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Dongguan, Guangdong and 1 other locations
- Ren Xuejun — Dongguan, Guangdong, China (Recruiting)
- Jie Yang — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: zhuxiao Ren, MD
- Email: renzhx1990@163.com
- Phone: +8613538984634
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.