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Prematurity | Autologous Umbilical Cord Blood Transfusion for Preterm Neonates

Prematurity research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Prematurity

Respiratory Distress Syndrome

Anemia of Prematurity

Intraventricular Hemorrhage

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Biological:Autologous cord blood transfusion for preterm neonatesCord 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 transfusionAfter 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%).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Autologous cord blood transfusionCollected cord blood at birth will be transfused for the preterm neonate

Study Status

Unknown status

Start Date: July 2011

Completed Date: September 2014

Phase: Phase 1

Type: Interventional

Design:

Primary Outcome: Duration of mechanical ventilation

Secondary Outcome: Survival

Study sponsors, principal investigator, and references

Principal Investigator: Prof. Sahar MA Hassanein, MD

Lead Sponsor: Sahar M.A. Hassanein, MD

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01121328

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