Effect of Autologous Cord Blood Mononuclear Cells for Prevention of Bronchopulmonary Dysplasia or Death in Extremely Preterm Neonates

Launched by GUANGDONG WOMEN AND CHILDREN HOSPITAL · Jun 18, 2020

Keywords

ClinConnect Summary

This clinical trial is studying whether infusing a type of blood cells from a baby’s umbilical cord can help prevent a serious lung condition called bronchopulmonary dysplasia (BPD) or death in extremely preterm infants born before 28 weeks of pregnancy. The trial involves 140 babies who will be randomly divided into two groups: one group will receive the cord blood cell infusion, and the other will receive a placebo (a harmless salt solution). The researchers will closely monitor the babies to see if the infusion helps them survive without developing BPD by 36 weeks of age or when they go home.

To participate in this trial, babies must meet certain criteria. They need to be born at the participating hospital, be single births, and be less than 28 weeks gestational age. Parents will need to give their permission for their baby to join the study, and there must be umbilical cord blood available for the procedure. Babies with severe birth defects or certain infections in the mother will not be included in the trial. Families can expect thorough follow-up care, and the study will also look at other health outcomes for the babies over the next two years. This research aims to provide important information that could improve care for preterm infants in the future.

Gender

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Eligibility criteria

• Inclusion Criteria:
• • Infants fulfilling all the following inclusion criteria will be enrolled in this trial: 1. born at study hospital; 2. singleton birth; 3. less than 28 weeks GA 4.Signed informed consent obtained; 5. had available umbilical cord blood (UCB).
• Exclusion Criteria:
• • Those infants are excluded if they were 1. with severe congenital abnormalities; 2.with maternal clinical chorioamnionitis 3. the mother was positive for hepatitis B (HBsAg and/or HBeAg) or C virus (anti-HCV), syphilis, HIV (anti-HIV-1 and -2) or IgM against cytomegalovirus, rubella, toxoplasma and herpes simplex virus.