Autologous Cord Blood Cells for Prevention of BPD in Preterm

yangjie

Status and phase

Completed

Phase 2

Conditions

Neonatal Death

BPD - Bronchopulmonary Dysplasia

Safety Issues

Treatments

Drug: 0.9% Sodiun Chloride

Other: Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

Study type

Interventional

Funder types

Other

Identifiers

NCT04311476

Guangdong WC H

Details and patient eligibility

About

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

Full description

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

Enrollment

62 patients

Sex

All

Ages

28 to 32 weeks old

Volunteers

No Healthy Volunteers

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.