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Cord Blood Transfusion In Preterm Neonates (CB-TrIP) (CB-TrIP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03764813
Recruitment Status : Recruiting
First Posted : December 5, 2018
Last Update Posted : April 5, 2019
Information provided by (Responsible Party):
Luciana Teofili, Policlinico Universitario Agostino Gemelli

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 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).

Condition or disease
Premature Infant Disease Transfusion Related Complication Fetal Hemoglobin

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, 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 value is considered.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.
Actual Study Start Date : December 5, 2018
Estimated Primary Completion Date : October 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Median HbF level at different weeks of PMA [ Time Frame: From enrollment to week 32 of PMA ]
    The average value of fetal Hb recorded for each week of PMA

Secondary Outcome Measures :
  1. Post-transfusion hematocrit (Htc) increase. [ Time Frame: From enrollment to week 32 of PMA ]
    The increase of Htc obtained as the difference between pre- and post-transusion Hct values.

  2. Intervals between transfusions [ Time Frame: From enrollment to week 32 of PMA ]
    Number of days between two consecutive transfusions

Biospecimen Retention:   Samples Without DNA
80-100 microL of capillary blood

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The CB TRIP trial enrolls preterm neonates born before the 30th week of gestation and/or neonates with birth weight <1000 grams, admitted to the NICU of Policlinico Gemelli, and candidate to receive one or more RBC transfusions. These characteristics (birth <28 weeks of gestation and birth weight <1000 grams) identify a very fragile population, with significant early mortality and morbidity and high risk for lifelong invalidating consequences.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03764813

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Contact: Luciana Teofili, MD, PhD 00390630154373
Contact: Patrizia Papacci, MD 00390630154357

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Fondazione Policlinico Universitario A. Gemelli IRCCS Recruiting
Roma, RM, Italy, 00168
Contact: Andrea Bacigalupo, Prof.    0630154180   
Fondazione Policlinico Universitario A.Gemelli IRCCS Recruiting
Rome, Italy, 00168
Contact: Patrizia Papacci, MD   
Contact: Luciana Teofili, MD   
Sponsors and Collaborators
Policlinico Universitario Agostino Gemelli
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Principal Investigator: Luciana Teofili, MD, PhD Fondazione Policlinico Agostino Gemelli IRCCS

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Responsible Party: Luciana Teofili, Medical Director of the UNICATT Cord Blood Bank, Policlinico Universitario Agostino Gemelli Identifier: NCT03764813     History of Changes
Other Study ID Numbers: 22139/18ID:1916
First Posted: December 5, 2018    Key Record Dates
Last Update Posted: April 5, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Infant, Premature, Diseases
Infant, Newborn, Diseases