N/A N=25

Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

Premature Infant Disease · Transfusion Related Complication · Fetal Hemoglobin

Bottom Line

View on ClinicalTrials.gov: NCT03764813 ↗

Enrolled (actual)

Serious AEs

48.0%

Results posted

Apr 2020

Primary outcome: Primary: Median Percentage of HbF at 32 Weeks of Post Menstrual Age — 93.2; 90.8; 58.0; 69.0 percentage of total Hb — p=<0.0001

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Primary completion: Aug 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Median Percentage of HbF at 32 Weeks of Post Menstrual Age	93.2; 90.8; 58.0; 69.0	<0.0001 sig
SECONDARY Post-transfusion Hematocrit (Htc) Change	9.0; 11.5	<0.05 sig
SECONDARY Intervals Between Transfusions	8.0; 7.0	<0.05 sig
SECONDARY Median Percentage of HbF at Last Assessment	92.3; 90.6; 53.6; 62.0	<0.0001 sig

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 contribute to exacerbating the oxidative damage responsible for prematurity diseases. The investigators hypothesized that transfusing red blood cells (RBC) obtained from allogeneic cord blood (CB) of healthy full-term babies (which contains almost exclusively HbF) may prevent the non-physiological decrease of HbF in premature neonates, likewise protecting them from oxygen radical diseases. Cord blood transfusion in preterms - CB TRIP - is a monocentric prospective nonrandomized study aimed to monitor HbF levels in preterm neonates receiving RBC transfusions from either umbilical blood of full-term healthy babies (CB-RBC) and/or from adult donors (A-RBC).

Eligibility Criteria

Inclusion Criteria

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 Criteria

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

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Data sourced from ClinicalTrials.gov (NCT03764813). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.