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Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

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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
Sponsor:
Information provided by (Responsible Party):
Sahar M.A. Hassanein, MD, Ain Shams University

Study Description
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Brief Summary:
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 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

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Non-Randomized
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

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Duration of mechanical ventilation [ Time Frame: 30 days ]
    -No need for mechanical ventilation.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   up to 30 Days   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

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


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
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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
First Posted: May 12, 2010    Key Record Dates
Last Update Posted: April 26, 2013
Last Verified: April 2013

Keywords provided by Sahar M.A. Hassanein, MD, 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