Autologous Umbilical Cord Blood Transfusion for Preterm Neonates - Full Text View

Sponsor:	Ain Shams University
Information provided by:	Ain Shams University
ClinicalTrials.gov Identifier:	NCT01121328

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

Resource links provided by NLM:

Genetics Home Reference related topics: COL4A1-related brain small-vessel disease

MedlinePlus related topics: Anemia Blood Transfusion and Donation

U.S. FDA Resources

Further study details as provided by Ain Shams University:

Primary Outcome Measures:

Duration of mechanical ventilation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
-No need for mechanical ventilation.

Secondary Outcome Measures:

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:	October 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Autologous cord blood transfusion	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

Arms

Assigned Interventions

Experimental: Autologous cord blood transfusion

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

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01121328

Contacts

Contact: Dr. Sahar MA Hassanein, MD

+20123183943

saharhassanein@yahoo.com

Locations

Egypt
Ain Shams University. Medical School
Cairo, Egypt

Sponsors and Collaborators

Ain Shams University

Investigators

Principal Investigator:

Prof. Sahar MA Hassanein, MD

Ain Shams University, Medical School

More Information

Additional Information:

Egyptian Society for Perinatal Neuro-Care This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Prof. Dr. Sahar M.A. Hassanein, Peditatric Department-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:	June 27, 2011
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:

Anemia
Hemorrhage
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Anemia, Neonatal
Infant, Premature, Diseases
Cerebral Hemorrhage
Hematologic Diseases
Pathologic Processes
Lung Diseases

Respiratory Tract Diseases
Respiration Disorders
Infant, Newborn, Diseases
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2012