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Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Primary Purpose

Prematurity, Respiratory Distress Syndrome, Anemia of Prematurity

Status
Withdrawn
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Autologous cord blood transfusion for preterm neonates
Autologous cord blood transfusion
Sponsored by
Sahar M.A. Hassanein, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prematurity focused on measuring Preterm neonates., Autologous cord blood transfusion.

Eligibility Criteria

1 Day - 30 Days (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Children's Hospital, Faculty of Medicine, Ain Shams University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Autologous cord blood transfusion

Arm Description

Collected cord blood at birth will be transfused for the preterm neonate

Outcomes

Primary Outcome Measures

Duration of mechanical ventilation
-No need for mechanical ventilation.

Secondary Outcome Measures

Survival
Survival until 12 months of age. Improved physical growth and weight gain. Neurodevelopmental outcome at 6, 12 and 18 months of age.

Full Information

First Posted
May 3, 2010
Last Updated
February 9, 2019
Sponsor
Sahar M.A. Hassanein, MD
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1. Study Identification

Unique Protocol Identification Number
NCT01121328
Brief Title
Autologous Umbilical Cord Blood Transfusion for Preterm Neonates
Official Title
Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Withdrawn
Why Stopped
No recruitment
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
September 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sahar M.A. Hassanein, MD

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prematurity, Respiratory Distress Syndrome, Anemia of Prematurity, Intraventricular Hemorrhage
Keywords
Preterm neonates., Autologous cord blood transfusion.

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Autologous cord blood transfusion
Arm Type
Experimental
Arm Description
Collected cord blood at birth will be transfused for the preterm neonate
Intervention Type
Biological
Intervention Name(s)
Autologous cord blood transfusion for preterm neonates
Other Intervention Name(s)
Transfusion blood bag collection.
Intervention 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%.
Intervention Type
Biological
Intervention Name(s)
Autologous cord blood transfusion
Other Intervention Name(s)
Cord blood transfusion for preterm neonates
Intervention 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%).
Primary Outcome Measure Information:
Title
Duration of mechanical ventilation
Description
-No need for mechanical ventilation.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Survival
Description
Survival until 12 months of age. Improved physical growth and weight gain. Neurodevelopmental outcome at 6, 12 and 18 months of age.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
30 Days
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prof. Sahar MA Hassanein, MD
Organizational Affiliation
Children's Hospital, Faculty of Medicine, Ain Shams University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital, Faculty of Medicine, Ain Shams University
City
Cairo
ZIP/Postal Code
11381
Country
Egypt

12. IPD Sharing Statement

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Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

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