Clinical trial NCT05087498: Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU
Official title: Effect of Autologous Cord Blood-mononuclear Cells Infusion on Immune Microenvironment in Infants Born Very Preterm in NICU: a Randomized Controlled Trial -The Premature Autologous Cord-blood Immunomodulatory Study (PAIRS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immunomodulation Effect
Keywords: autologous cord blood mononuclear cells
monozygotic twins
very premature infants
Lead sponsor: Guangdong Women and Children Hospital
Sponsor class: OTHER
First posted: 2021-10-21
Enrollment: 8
Sex: ALL
Minimum age (years): 24
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: immunomodulation effect
timeFrame: during 7 days after intervention
measure: success rate of cord blood collection
timeFrame: during 6 months after intervention
measure: complications
timeFrame: during 6 months after intervention
Secondary outcomes:
Other outcomes:
measure: Duration of mechanical ventilation, oxygen therapy and hospitalization
timeFrame: 36 weeks of postmenstrual age or the discharge
measure: the frequence of glucocorticoid, pulmonary surfactant, blood products and re-intubation
timeFrame: 36 weeks of postmenstrual age or the discharge
Locations:
city: Guangzhou
country: China
facility: Jie Yang
state: Guangdong
Study officials:
affiliation: Guangdong Women and Children Hospital
name: Jie Yang
role: STUDY_CHAIR
References: