NCT01121328

Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study

• Status: Withdrawn
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sahar M.A. Hassanein, MD · Academic / Other
• Sex: All
• Age: 1 Day – 30 Days
• Healthy volunteers: Not accepted

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.

Conditions

• Prematurity
• Respiratory Distress Syndrome
• Anemia of Prematurity
• Intraventricular Hemorrhage

Interventions

Type	Name	Description
BIOLOGICAL	Autologous cord blood transfusion for preterm neonates	Cord blood collection after delivery of the baby. Preservation of blood in blood bank. Transfusion of blood within the first 14 postnatal days to maintain Hb level above 10gm%.
BIOLOGICAL	Autologous cord blood transfusion	After delivery of the baby and before placental delivery in vaginal delivery. After delivery of the baby the placental will be taken out in cesarean section. sterilization of the umbilical cord will be done. Puncture of the umbilical cord vein with the needle of blood transfusion bag will be done. Blood will be kept in the blood bank. Blood grouping, haematocrit and CBC will be done for the cord blood.Maternal sample will be analysed simultaneously. Mononuclear layer will be separated within 6 hours and transfused to the preterm neonate immediately. RBCs will be separated and kept till need (Hb less than 10 gm%).

Timeline

• Start date: 2011-07-01
• Primary completion: 2014-03-01
• Completion: 2014-09-01
• First posted: 2010-05-12
• Last updated: 2019-02-12

Locations

1 site across 1 country: Egypt