Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Phase 1

Withdrawn

• Conditions: Intraventricular Hemorrhage; Respiratory Distress Syndrome; Anemia of Prematurity; Prematurity
• Interventions: Biological: Autologous cord blood transfusion for preterm neonates; Biological: Autologous cord blood transfusion

• Registration Number: NCT01121328
• Lead Sponsor: Sahar M.A. Hassanein, MD

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.

Study Timeline

• Study First Submitted: 2010-05-03
• Study First Submitted QC: 2010-05-10
• Study First Posted: 2010-05-12
• Study Start: 2011-07
• Primary Completion: 2014-03
• Study Completion: 2014-09
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-09
• Last Update Posted: 2019-02-12

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous cord blood transfusion	Autologous cord blood transfusion for preterm neonates	Collected cord blood at birth will be transfused for the preterm neonate
Autologous cord blood transfusion	Autologous cord blood transfusion	Collected cord blood at birth will be transfused for the preterm neonate

Primary Outcome Measures

Name	Time	Method
Duration of mechanical ventilation	30 days	-No need for mechanical ventilation.

Secondary Outcome Measures

Name	Time	Method
Survival	18 months	* Survival until 12 months of age.; * Improved physical growth and weight gain.; * Neurodevelopmental outcome at 6, 12 and 18 months of age.

Trial Locations

Locations (1)

Children's Hospital, Faculty of Medicine, Ain Shams University; 🇪🇬 Cairo, Egypt