Autologous Cord Blood Cells for Prevention of BPD in Preterm

Study Overview
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Brief Summary
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To study the effect of Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

Detailed Description
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We did a randomized, double-blind, placebo-controlled trial to assess effect of one intravenous dose of cord blood MNCs compared with placebo in reducing incidence of BPD in very preterm neonates.We enrolled preterm neonates less than 32 weeks of GA at neonatal intensive care units (NICUs) in Guangdong Women and Children Hospital within the first 24 postnatal hours. Patients were randomly assigned by 1:1 to receive either (5×107cells/kg ACBMNC or normal saline intravenously within 24 hours after birth according to a computer-generated schedule. The primary endpoint was efficacy at 36 GA or discharge home and all analyses were done by intention to prevent.MNCs viability was also tested before transfusion

Official Title
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Autologous Cord Blood Cells for Prevention of BPD in Preterm

Conditions
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Safety Issues, BPD - Bronchopulmonary Dysplasia, Neonatal Death

Intervention / Treatment
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* Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy
* Drug: 0.9% Sodiun Chloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: born in the study hospital; singleton birth; less than 32 weeks GA Without congenital malformations or known chromosomal aberrations; Without clinical chorioamnionitis; the mother was negative for hepatitis B (HBsAg and/or HBeAg) and C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) and IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus; consents were obtained from their parents or guardians; the umbilical cord blood cells after processing were available. Exclusion Criteria: birth-weight was less than the third percentile for gestational age according to Fenton curve, if they had severe perinatal asphyxia (defined as an Apgarscore of 0-3 for more than 5 minutes, a cord blood pH of less than 7.00, or both) and were expected to die shortly after birth.

Ages Eligible for Study
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Minimum Age: 28 Weeks
Maximum Age: 32 Weeks

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>0.9% sodium chloride infusion within 24 hours after birth | Drug: 0.9% Sodiun Chloride<br>* 0.9% Sodiun Chloride in control group<br>|
| Experimental: ACBMNC<br>Autologous Umbilical Cord Blood Mononuclear Cells intravenously within 24 hours after birth,dose is 5×107cells/kg , | Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy<br>* Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates<br>* Other names: Autologous Umbilical Cord Blood Mononuclear Cells Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients without bronchopulmonary dysplasia | bronchopulmonary dysplasia incidence | at 36 weeks of postmenstrual age or discharge home, whichever came first | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who died， severe bronchopulmonary dysplasia | mortaliity rate | at 36 weeks of postmenstrual age | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ACBMNC, very premature infants, BPD