Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prematurity
- Sponsor
- Sahar M.A. Hassanein, MD
- Locations
- 1
- Primary Endpoint
- Duration of mechanical ventilation
- Status
- Withdrawn
- Last Updated
- 7 years ago
Overview
Brief Summary
This is a pilot study to test feasibility of collection, preparation and infusion of a baby's own (autologous) umbilical cord blood in the first 14 days after birth if the baby is born premature <35 weeks of gestation.
Detailed Description
In Egypt, 12-15.8% of live neonates are low birth weight and it is estimated that about one third of such infants are preterm \[1\] (UNICEF, 2001). In a study that Campbell et al. (2004) conducted in Egypt, the neonatal mortality rate was estimated to be 25 per 1000 live births. prematurity was considered the main cause of neonatal deaths (39%), followed by asphyxia (18%), infection (7%), especially in the late neonatal period, and congenital malformations (6%). A substantial proportion (29%) could not be classified \[2\]. In developing countries, prematurity was the main cause of early neonatal deaths (62%)\[3\] Autologous cord blood transfusion will be safe, and cheap. The preterm neonates need transfusion of whole blood or any of its components at a time during NICU admission.
Investigators
Sahar M.A. Hassanein, MD
Professor of Pediatrics, Children's Hospital, Faculty of Medicine
Ain Shams University
Eligibility Criteria
Inclusion Criteria
- •Preterm neonates less than 34 weeks of gestation.
- •Low birth weight less than 1500 grams
Exclusion Criteria
- •Congenital malformations.
- •Suspected inborn error of metabolism.
- •Suspected inherited neurologic disease.
Outcomes
Primary Outcomes
Duration of mechanical ventilation
Time Frame: 30 days
-No need for mechanical ventilation.
Secondary Outcomes
- Survival(18 months)