Autologous Umbilical Cord Blood Transfusion for Preterm Neonates
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01121328|
Recruitment Status : Unknown
Verified April 2013 by Sahar M.A. Hassanein, MD, Ain Shams University.
Recruitment status was: Recruiting
First Posted : May 12, 2010
Last Update Posted : April 26, 2013
|Condition or disease||Intervention/treatment||Phase|
|Prematurity Respiratory Distress Syndrome Anemia of Prematurity Intraventricular Hemorrhage||Biological: Autologous cord blood transfusion for preterm neonates Biological: Autologous cord blood transfusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study|
|Study Start Date :||July 2011|
|Estimated Primary Completion Date :||March 2014|
|Estimated Study Completion Date :||September 2014|
Experimental: Autologous cord blood transfusion
Collected cord blood at birth will be transfused for the preterm neonate
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%.
Other Name: Transfusion blood bag collection.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%).
Other Name: Cord blood transfusion for preterm neonates
- Duration of mechanical ventilation [ Time Frame: 30 days ]-No need for mechanical ventilation.
- Survival [ Time Frame: 18 months ]
- Survival until 12 months of age.
- Improved physical growth and weight gain.
- Neurodevelopmental outcome at 6, 12 and 18 months of age.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01121328
|Contact: Dr. Sahar MA Hassanein, MDemail@example.com|
|Children's Hospital, Faculty of Medicine, Ain Shams University||Recruiting|
|Cairo, Egypt, 11381|
|Contact: Mohsen Elalfy, MD +201000864343|
|Principal Investigator: Prof. Dr. Sahar MA Hassanein, MD|
|Principal Investigator:||Prof. Sahar MA Hassanein, MD||Children's Hospital, Faculty of Medicine, Ain Shams University|