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COMPLETEDNCT03764813

Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

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...

Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS•2 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

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, RBC concentrates obtained from umbilical blood of full-term healthy babies are utilized, if available; otherwise, RBC concentrates from adult donors are assigned. For every week of PMA, neonates undergo a minimum of three HbF determinations, and the median values are considered.

Age

All ages

Sex

ALL

Healthy Volunteers

No

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 from ClinicalTrials.govLast updated on ClinicalTrials.gov: August 17, 2021Terms

Trial snapshot

StatusCOMPLETED

Phase—

Enrollment25

Start dateDec 2018

Last updatedAug 17, 2021

Condition

Premature Infant Disease Transfusion Related Complication Fetal Hemoglobin

Locations shown

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 17, 2021Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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