Effect of Autologous Cord Blood Mononuclear Cell in Preventing Complications of Monozygotic Twins in Very Premature Infants
Study Details
Study Description
Brief Summary
This is a trial that evaluates the efficacy of autologous cord blood mononuclear cells infusion as a prevention therapy for complications of very premature infants. In this single-center clinical trial, 30 pairs of twins neonates less than 32 weeks are included. They are randomly divided into ACBMNC infusion group and (placebo) group. The primary outcome is the rate of complications at 36 weeks of postmenstrual age or discharge home. The secondary outcomes will include respiratory support duration, frequence of incubate, use of glucocorticoid, pulmonary surfactant and blood, duration of hospitalization and long term outcomes after two years follow up post infusion.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Detailed Description
Study design and settings:
This study will be a randomized, placebo-controlled, double-blinded, single-center trial. A total of 30 pairs of monozygotic twins fulfilling the eligibility criteria will be enrolled. Subsequently, one baby of each twin will be randomly divided into the ACBMNC infusion group or control (placebo) group.
Trial treatment methods:
Soon after the preterm infant was deliveried, written consent was signed by the parents, and autologous cord blood infusion was applied to the baby in addition to routine treatment. Those assigned to the ACBMNC group received an infusion of ACBMNC . Those in control group received an infusion of a placebo solution. Informed consent before birth is signed. Preterm infants in the ACBMNC infusion group will have their umbilical cord blood collected after birth, and then their umbilical cord blood will be separated through Guangdong Province umbilical cord blood Bank to obtain mesenchymal stem cells. Within 24h after birth, ACBMNC group received an infusion of mesenchymal stem cells timely, while control (placebo) group received an infusion of a placebo solution which is normal saline with the same volume. Cell dose for all patients was targeted at 5×107 cells per kilogram.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: ACBMNC infusion group Those assigned to the ACBMNC group will receive intravenous autologous cord blood mononuclear cells infusion within 24 h after birth. Cell dose for all patients was targeted at 5×107 cells per kilogram. |
Biological: autologous cord blood mononuclear cells
preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (5×107cells/kg) within 24 hours after birth
|
| Placebo Comparator: control group Those in control group will receive an infusion of a placebo solution which is normal saline with the same volume. |
Biological: normal saline
preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth
|
Outcome Measures
Primary Outcome Measures
- Number of participants with complications according to their diagnostic criteria [36 weeks of postmenstrual age or discharge home whichever comes first.]
Collected number of participants with complications (e.g., 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) ) according to their diagnostic criteria at 36 weeks of postmenstrual age or discharge home whichever comes first, and then calculate their rate separately
Secondary Outcome Measures
- Frequence of hospitalizations for pneumonia of each participants [1 year of postmenstrual age]
The frequence of hospitalizations for pneumonia at 1 year of postmenstrual age
Other Outcome Measures
- Duration of mechanical ventilation, oxygen therapy and hospitalization [36 weeks of postmenstrual age or the discharge]
Duration of mechanical ventilation, oxygen therapy and hospitalization at 36 weeks of postmenstrual age or the discharge
- the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation [36 weeks of postmenstrual age or the discharge]
the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation at 36 weeks of postmenstrual age or the discharge
Eligibility Criteria
Criteria
Inclusion Criteria:
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- born at study hospital;
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- monozygotic twins less than 32 weeks GA.
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3.Signed informed consent obtained;
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- available and qualified umbilical cord blood (UCB).
Exclusion Criteria:
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- with severe congenital abnormalities;
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2.with maternal clinical chorioamnionitis
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- 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ren Xuejun | Dongguan | Guangdong | China | |
| 2 | Jie Yang | Guangzhou | Guangdong | China | 511400 |
Sponsors and Collaborators
- Guangdong Women and Children Hospital
Investigators
- Study Chair: Jie Yang, Guangdong Women and Children Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Guangdong M CH