Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
Autologous Umbilical Cord Blood Transfusion for Preterm Neonates
Sponsors
Source
Ain Shams University
Oversight Info
Has Dmc
No
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.
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.
Overall Status
Unknown status
Start Date
2011-07-01
Completion Date
2014-09-01
Primary Completion Date
2014-03-01
Phase
Phase 1
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Duration of mechanical ventilation |
30 days |
Secondary Outcome
Measure |
Time Frame |
|
Survival |
18 months |
Enrollment
60
Conditions
Intervention
Intervention Type
Biological
Intervention Name
Description
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%.
Arm Group Label
Autologous cord blood transfusion
Other Name
Transfusion blood bag collection.
Intervention Type
Biological
Intervention Name
Description
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%).
Arm Group Label
Autologous cord blood transfusion
Other Name
Cord blood transfusion for preterm neonates
Eligibility
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.
Gender
All
Minimum Age
N/A
Maximum Age
30 Days
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Prof. Sahar MA Hassanein, MD |
Principal Investigator |
Children's Hospital, Faculty of Medicine, Ain Shams University |
Overall Contact
Location
Facility |
Status |
Contact |
Investigator |
|
Children's Hospital, Faculty of Medicine, Ain Shams University Cairo 11381 Egypt |
Recruiting |
Last Name: Mohsen Elalfy, MD Phone: +201000864343 |
Last Name: Prof. Dr. Sahar MA Hassanein, MD Role: Principal Investigator |
Location Countries
Country
Egypt
Verification Date
2013-04-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor-Investigator
Investigator Affiliation
Ain Shams University
Investigator Full Name
Sahar M.A. Hassanein, MD
Investigator Title
Professor of Pediatrics, Children's Hospital, Faculty of Medicine
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
1
Arm Group
Arm Group Label
Autologous cord blood transfusion
Arm Group Type
Experimental
Description
Collected cord blood at birth will be transfused for the preterm neonate
Firstreceived Results Date
N/A
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Non-Randomized
Intervention Model
Single Group Assignment
Primary Purpose
Supportive Care
Masking
None (Open Label)
Study First Submitted
May 3, 2010
Study First Submitted Qc
May 10, 2010
Study First Posted
May 12, 2010
Last Update Submitted
April 25, 2013
Last Update Submitted Qc
April 25, 2013
Last Update Posted
April 26, 2013
Last Known Status
Recruiting
ClinicalTrials.gov processed this data on August 29, 2018
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.