Autologous Umbilical Cord Blood Mononuclear Layer Transfusion for Neonates with Encephalopathy: A Pilot Feasibility Study

Not Applicable

• Conditions: eonatal Encephalopathy.; Asphyxia and traumatic brain injury.; Neonatal Encephalopathy.; Neurological - Other neurological disorders; Reproductive Health and Childbirth - Complications of newborn

• Registration Number: ACTRN12610000421033
• Lead Sponsor: Ain Shams University, Faculty of Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-05-26
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

*Mothers must have consented for cord blood collection at delivery
*cord blood must be available for extraction of stem cells.
*>30 weeks gestation
*High risk pregnancies.
*All infants must have signs of encephalopathy within 6 hours of age.

Exclusion Criteria

*Presence of known chromosomal anomaly.
*Presence of major congenital anomalies.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event rates occurring in the pilot study population will be compared between the cord blood cell recipients and historical controls. Occurance of blood pressure fluctuation, changes in heart rate, reaction to blood transfusion. The baby will be monitored for mean arterial blood pressure and heart rate and blood analysis .[1 month following transfusion.]

Secondary Outcome Measures

Name	Time	Method
Prevention of brain injury as measured by neurodevelopmental function at 4 - 6 months and 9 - 12 months of age.Bayley II Scales of Infant Development will be used.[4-6 months and 9-12 months of age.];Magnetic resonance imaging (MRI) findings compared to historical non interventional group. MRI score will be used.[1 year of age.]