Status:
COMPLETED
Cord Blood Transfusion In Preterm Neonates (CB-TrIP)
Lead Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Conditions:
Premature Infant Disease
Transfusion Related Complication
Eligibility:
All Genders
Brief Summary
Repeated transfusions have been associated with very poor outcome of preterm infants. Fetal hemoglobin (HbF) and adult Hb (HbA) have different affinity for oxygen. The high level of adult Hb may contr...
Detailed Description
Preterm neonates enrolled in this study are monitored for the level of HbF on capillary blood samples, from birth to the week 32 of postmenstrual age (PMA). To fulfill the RBC transfusion requirements...
Eligibility Criteria
Inclusion
- preterm neonates born at PMA ≤30 weeks and/or with birth weight ≤1000 g born at the delivery room of Fondazione Policlinico Universitario A. Gemelli candidate to receive one or more RBC unit transfusion.
Exclusion
- One or more of the following criteria Maternal-fetal immunization Hydrops fetalis Major congenital malformations associated or not with genetic syndromes Previous transfusions Hemorrhage at birth Congenital infections (such as infections from TORCH complex) Out-born infants The health care team deems it inappropriate to approach the infant's family for informed consent
Key Trial Info
Start Date :
December 5 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 2 2019
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT03764813
Start Date
December 5 2018
End Date
August 2 2019
Last Update
August 17 2021
Active Locations (2)
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1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, Italy, 00168
2
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, Italy, 00168