Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Respiratory Distress Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01121328
• Other study ID #: IRB#1
• Status: Withdrawn
• Phase: Phase 1
• Start date: July 2011
• Est. completion date: September 2014

Study information

• Verified date: February 2019
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 30 Days

Eligibility

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.

Related Conditions & MeSH terms

• Anemia of Prematurity
• Cerebral Hemorrhage
• Hemorrhage
• Intraventricular Hemorrhage
• Premature Birth
• Prematurity
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Adult
• Respiratory Distress Syndrome, Newborn

Intervention

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%.
• 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%).

Locations

Country	Name	City	State
Egypt	Children's Hospital, Faculty of Medicine, Ain Shams University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Sahar M.A. Hassanein, MD

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of mechanical ventilation	-No need for mechanical ventilation.	30 days
Secondary	Survival	Survival until 12 months of age.; Improved physical growth and weight gain.; Neurodevelopmental outcome at 6, 12 and 18 months of age.	18 months