A Phase 1 interventional study of Autologous cord blood transfusion for preterm neonates and Autologous cord blood transfusion in Prematurity, Respiratory Distress Syndrome and Anemia of Prematurity, sponsored by Sahar M.A. Hassanein, MD. Withdrawn at 1 site in Egypt. Open to participants aged 1 Day to 30 Days. Per ClinicalTrials.gov, last updated 2019-02-12.
Sponsored by Sahar M.A. Hassanein, MD · Phase 1, Interventional, and Supportive care
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.
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.
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Exclusion Criteria:
Collected cord blood at birth will be transfused for the preterm neonate
Biological: Autologous cord blood transfusion for preterm neonates · Biological: Autologous cord blood transfusion
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%.
Also known as: Transfusion blood bag collection.
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%).
Also known as: Cord blood transfusion for preterm neonates
Duration of mechanical ventilation
-No need for mechanical ventilation.
Time frame: 30 days
Survival
* Survival until 12 months of age. * Improved physical growth and weight gain. * Neurodevelopmental outcome at 6, 12 and 18 months of age.
Time frame: 18 months
The record gives a start of Jul 2011, a primary completion of Mar 2014 and a completion of Sep 2014. It does not say whether these dates are actual or estimated.
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This study is withdrawn, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Sahar M.A. Hassanein, MD