Immunomodulation Effect
Conditions
Keywords
autologous cord blood mononuclear cells, monozygotic twins, very premature infants
Brief summary
Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with intravenous ACBMNC infusion in very preterm monozygotic twins
Detailed description
This was a randomized, placebo-controlled, double-blinded trial involving eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair. Multi-omics (analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction) analysis was used to profile immune alternation of infants with ACB-MNCs infusion, along with paired controls. Feasibility, safety and clinical outcomes improvement of the ACB-MNCs infusion in both short and long term were also assessed.
Interventions
BIOLOGICALautologous cord blood mononuclear cells
preterm neonates less than 32 weeks are assigned to receive intravenous autologous cord blood mononuclear cells infusion (2-10×107cells/kg) within 24 hours after birth
BIOLOGICALnormal saline
preterm neonates less than 32 weeks are assigned to receive normal saline within 24 hours after birth
Sponsors
Guangdong Women and Children Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Once the enrollment was confirmed, the research physician contacted the research nurse. They were informed with the assignment and prepared the processed cord blood MNC or normal saline. After preparation, infusion bag was covered with shading bag and infused by light-blocking infusion tube, so that the nurses who conducted the infusion and all physicians who treated the baby were not aware of the treatment assignment. We used the code name of ACBMNC number 1 or number 2 to name the infusion fluid in the computerized physician order entry. The staff who collected and analyzed the patients' data and who followed up the patients were also blinded with the assignment. The research nurse and physician that knew the allocation of treatment did not make decisions in baby's clinical care. The parents or guardians were also not aware of the assignment. Therefore, this study was double-blinded.
Intervention model description
eight pairs of VPMTs who were admitted to NICU to receive respiratory support right after birth. The infants were assigned (1:1) to receiving at least 2×107 ACB-MNCs/kg or normal saline, intravenously, within 24-h post-enrollment within each pair.
Eligibility
Sex/Gender
ALL
Age
24 Weeks to 32 Weeks
Healthy volunteers
Yes
Inclusion criteria
1. born at study hospitals; 2. monozygotic twins (confirmed by ultrasonographic diagnosis before birth and confirm again with obstetricians during and after delivery, as monochorionic diamniotic twins and monochorionic monoamniotic Twins twins were both monozygotic twins, therefore they will be both eligible); 3. gestational age (GA) \<32 weeks (GA was calculated based on the date of the last menstrual period of the mother and an ultrasonographic screening performed during the first trimester of pregnancy); 4. enrolled within the first 24 postnatal hours; 5. free of severe perinatal asphyxia (defined as an Apgar score of 0-3 for more than 5 minutes, a cord blood gas pH \<7.00, or both); 6. free of severe congenital anomalies or genetic syndromes; 7. free of maternal sepsis24,25; 8. Written informed consent is obtained from the parents or guardians of the infants; 9. Either of the twins has available umbilical cord blood (UCB) , and the cell number was no more than 10×107 cells per kilogram, but should not be less than 2×107 cells per kilogram.
Exclusion criteria
(1) they exhibit severe congenital abnormalities (detected via prenatal ultrasound); (2) expected to die within the first 24 hours; (3) diagnosed with severe twin-to-twin transfusion syndrome confirmed by prenatal ultrasonography24.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| immunomodulation effect | during 7 days after intervention | analysis of peripheral blood immune cells subset, peripheral blood MNCs transcriptome, soluble inflammatory cytokine profile in blood and airway secretion, lung and gut microbiota, and the interaction |
| success rate of cord blood collection | during 6 months after intervention | cord blood collection, cell available, infused cell number |
| complications | during 6 months after intervention | frequency of complications such IVH, NEC, retinopathy of prematurity (ROP), respiratory distress syndrome (RDS), LOS, and persistent pulmonary hypertension of newborn (PPHN) and anemia. |
Other
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
China
Outcome results
None listed