Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Sahar M.A. Hassanein, MD

Status and phase: Withdrawn; Phase 1

Conditions: Anemia of Prematurity; Prematurity; Respiratory Distress Syndrome; Intraventricular Hemorrhage

Treatments: Biological: Autologous cord blood transfusion for preterm neonates; Biological: Autologous cord blood transfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT01121328

IRB#1

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 1 to 30 days old

Volunteers: No 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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Autologous cord blood transfusion

Experimental group

Description:

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

Treatment:

Biological: Autologous cord blood transfusion

Biological: Autologous cord blood transfusion for preterm neonates