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Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2013 by Ain Shams University.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University
ClinicalTrials.gov Identifier:
NCT01121328
First received: May 3, 2010
Last updated: April 25, 2013
Last verified: April 2013
History of Changes
  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:

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: 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   (Child)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contacts
Contact: Dr. Sahar MA Hassanein, MD +20123183943 saharhassanein@med.asu.edu.eg

Locations
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         
Sponsors and Collaborators
Sahar M.A. Hassanein, MD
Investigators
Principal Investigator: Prof. Sahar MA Hassanein, MD Children's Hospital, Faculty of Medicine, Ain Shams University
  More Information

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:
Hemorrhage
Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Premature Birth
Cerebral Hemorrhage
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
 Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 23, 2016