Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

NCT ID: NCT01121328

Last Updated: 2019-02-12

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE1
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2014-09-30

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.

Conditions

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Autologous cord blood transfusion

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

Group Type: EXPERIMENTAL

Autologous cord blood transfusion for preterm neonates

Intervention Type: BIOLOGICAL

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

Intervention Type: BIOLOGICAL

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%).

Interventions

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%.

Intervention Type: 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%).

Intervention Type: BIOLOGICAL

Other Intervention Names

Transfusion blood bag collection.; Cord blood transfusion for preterm neonates

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.

• Minimum Eligible Age: 1 Day
• Maximum Eligible Age: 30 Days
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sahar M.A. Hassanein, MD

OTHER

Sponsor Role: lead

Responsible Party

Sahar M.A. Hassanein, MD

Professor of Pediatrics, Children's Hospital, Faculty of Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Prof. Sahar MA Hassanein, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Cairo, , Egypt

Countries

Egypt

Other Identifiers

IRB#1

Identifier Type: -

Identifier Source: org_study_id