Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

February 9, 2019 updated by: Sahar M.A. Hassanein, MD

Autologous Umbilical Cord Blood Transfusion for Preterm and Low Birth Weight Neonates: A Pilot Feasibility Study

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 11381
        • Children's Hospital, Faculty of Medicine, Ain Shams University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 day to 1 month (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • Cord blood transfusion for preterm neonates

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of mechanical ventilation
Time Frame: 30 days
-No need for mechanical ventilation.
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sahar M.A. Hassanein, MD

Investigators

  • Principal Investigator: Prof. Sahar MA Hassanein, MD, Children's Hospital, Faculty of Medicine, Ain Shams University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

May 3, 2010

First Submitted That Met QC Criteria

May 10, 2010

First Posted (Estimate)

May 12, 2010

Study Record Updates

Last Update Posted (Actual)

February 12, 2019

Last Update Submitted That Met QC Criteria

February 9, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB#1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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