Autologous Cord Blood Cells for Prevention of BPD in Preterm

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04311476

Enrollment

Registered

2020-03-17

Start date

2018-07-01

Completion date

2020-01-01

Last updated

2020-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

BPD - Bronchopulmonary Dysplasia, Neonatal Death, Safety Issues

Keywords

ACBMNC, very premature infants, BPD

Brief summary

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

Detailed 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

Interventions

OTHERAutologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

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

DRUG0.9% Sodiun Chloride

0.9% Sodiun Chloride in control group

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

28 Weeks to 32 Weeks

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.

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
number of patients who died， severe bronchopulmonary dysplasia	at 36 weeks of postmenstrual age	mortaliity rate

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026