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Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

NCT01121328 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2019-02-12

No results posted yet for this study

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

Interventions

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%.

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%).

Sponsors & Collaborators

  • Sahar M.A. Hassanein, MD

    lead OTHER

Principal Investigators

  • Prof. Sahar MA Hassanein, MD · Children's Hospital, Faculty of Medicine, Ain Shams University

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Day
Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2014-03-31
Completion
2014-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01121328 on ClinicalTrials.gov