This study will test the safety and efficacy of an infusion of a baby's own (autologous) umbilical cord blood as compared with placebo in babies born with history and signs of hypoxic-ischemic brain injury.
The purpose of this phase II study is to assess the safety and efficacy of up to two intravenous infusions of autologous volume and red blood cell reduced nucleated umbilical cord blood cells as compared with placebo in neonates with neonatal encephalopathy undergoing hypothermia treatment. Efficacy will be estimated by one year survival and score on Bayley III scores in all three domains equal to or greater than 85. This will be a randomized, double-blind, placebo controlled multi-site trial of up to 160 infants who qualify for cooling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
35
Infants who meet study enrollment criteria will receive up to 2 infusions of their own volume reduced cord blood cells. The number of doses will be determined by the amount of available cord blood cells.
Infants who meet study enrollment criteria will receive up to 2 placebo infusions composed of an equivalent volume (volume of product that would have been administered if the infant randomized to the intervention arm) of packed red blood cells (PRBCs) from the red cell compartment of the separated cord blood unit.
Duke University Medical Center
Durham, North Carolina, United States
Survival at One Year
Number of participants alive at one year.
Time frame: 1 year
Number of Participants With Bayley III Scores in All Three Domains > or Equal to 85
The Bayley is a standardized, norm-referenced measure that assesses development in Cognitive, Language and Motor domains. Composite standard scores can be derived that have a mean of 100 and a standard deviation of 15.
Time frame: 1 year
Mortality Rate
(Number of participants who died/total number of participants) x 100
Time frame: 1 year
Number of Subjects Who Experience Seizures
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require iNO (Inhaled Nitric Oxide) Use
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require ECMO
ECMO (extracorporeal membrane oxygenation) is a technique of providing prolonged cardiac and respiratory support to persons whose heart and lungs are unable to provide an adequate amount of gas exchange or perfusion to sustain life.
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Require Gastrostomy Tube (G-tube) Feeding
Time frame: During hospitalization, approximately 4-92 days
Number of Subjects Who Are Discharged on Anti-epileptic Medication
Time frame: At hospital discharge, approximately 4-92 days
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.