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Completed

NCT Number: NCT04311476

Autologous Cord Blood Cells for Prevention of BPD in Preterm

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

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Autologous Umbilical Cord Blood Mononuclear Cells infusion Therapy

Other

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

Other names: Autologous Umbilical Cord Blood Mononuclear Cells Therapy

0.9% Sodiun Chloride

Drug

0.9% Sodiun Chloride in control group

Primary outcomes

  1. number of patients without bronchopulmonary dysplasia

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

    bronchopulmonary dysplasia incidence

Secondary outcomes

  1. number of patients who died, severe bronchopulmonary dysplasia

    Time frame: at 36 weeks of postmenstrual age

    mortaliity rate

Sponsors and collaborators

Lead sponsor

yangjie

Other

Registry information

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Mar 17, 2020
Registry last updated
Jun 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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