Autologous Cord Blood Cells for Prevention of BPD in Preterm

yangjie62 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Safety Issues BPD - Bronchopulmonary Dysplasia Neonatal Death

Interventions

Autologous Umbilical Cord Blood Mononuclear Cells infusion TherapyOTHER

Evaluate Autologous cord blood cells infusion on prevention of bronchopulmonary dysplasia in very preterm neonates

0.9% Sodiun ChlorideDRUG

0.9% Sodiun Chloride in control group

Eligibility

Sex: ALLMin age: 28 WeeksMax age: 32 Weeks

Medical Language ↔ Plain English

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.

Locations (1)

Jie Yang

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

number of patients without bronchopulmonary dysplasia

bronchopulmonary dysplasia incidence

Time frame: at 36 weeks of postmenstrual age or discharge home, whichever came first

Secondary Outcomes

number of patients who died， severe bronchopulmonary dysplasia

mortaliity rate

Time frame: at 36 weeks of postmenstrual age

Data from ClinicalTrials.gov

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