Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

NCT01121328 | Withdrawn Phase 1

• 1 other identifier: IRB#1
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Preterm neonates.; Autologous cord blood transfusion.

Outcome Measures

Primary Outcomes (1)

• Duration of mechanical ventilation

  -No need for mechanical ventilation.

  30 days

Secondary Outcomes (1)

• Survival

  18 months

Study Arms (1)

Autologous cord blood transfusion

EXPERIMENTAL

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

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

Interventions

Autologous cord blood transfusion for preterm neonates 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%.

Also known as: Transfusion blood bag collection.

Autologous cord blood transfusion

Autologous cord blood transfusion 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%).

Also known as: Cord blood transfusion for preterm neonates

Autologous cord blood transfusion

Eligibility Criteria

• Age: 1 Day - 30 Days
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Preterm neonates less than 34 weeks of gestation.
• Low birth weight less than 1500 grams

You may not qualify if:

• Congenital malformations.
• Suspected inborn error of metabolism.
• Suspected inherited neurologic disease.

Sponsors & Collaborators

• Sahar M.A. Hassanein, MD: lead

Study Sites (1)

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

Cairo, 11381, Egypt

Location

MeSH Terms

Conditions

Premature Birth; Respiratory Distress Syndrome; Anemia

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Prof. Sahar MA Hassanein, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Pediatrics, Children's Hospital, Faculty of Medicine

Study Record Dates

• First Submitted: May 3, 2010
• First Posted: May 12, 2010
• Study Start: July 1, 2011
• Primary Completion: March 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 12, 2019

Record last verified: 2019-02

Locations

EG (1)