Autologous Umbilical Cord Blood Transfusion for Preterm Neonates
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Purpose
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.
| Condition | Intervention | 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 |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study |
- Duration of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]-No need for mechanical ventilation.
- Survival [ Time Frame: 18 months ] [ Designated as safety issue: No ]
- Survival until 12 months of age.
- Improved physical growth and weight gain.
- Neurodevelopmental outcome at 6, 12 and 18 months of age.
| Estimated Enrollment: | 60 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | September 2014 |
| Estimated Primary Completion Date: | March 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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.
Eligibility| Ages Eligible for Study: | up to 30 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01121328
| Contact: Dr. Sahar MA Hassanein, MD | +20123183943 | saharhassanein@med.asu.edu.eg |
| Egypt | |
| 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 |
More Information
No publications provided
| Responsible Party: | Sahar M.A. Hassanein, MD, Professor of Pediatrics, Children's Hospital, Faculty of Medicine, Ain Shams University |
| ClinicalTrials.gov Identifier: | NCT01121328 History of Changes |
| Other Study ID Numbers: | IRB#1 |
| Study First Received: | May 3, 2010 |
| Last Updated: | April 25, 2013 |
| Health Authority: | Egypt: Ministry of Health, Drug Policy and Planning Center |
Keywords provided by Ain Shams University:
|
Preterm neonates. Autologous cord blood transfusion. |
Additional relevant MeSH terms:
|
Respiratory Distress Syndrome, Newborn Infant, Newborn, Diseases Infant, Premature, Diseases |
Lung Diseases Respiration Disorders Respiratory Tract Diseases |
ClinicalTrials.gov processed this record on March 03, 2015