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

August 16, 2021 updated by: TEOFILI LUCIANA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.

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).

Study Overview

Status

Completed

Conditions

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 values are considered.

Study Type

Observational

Enrollment (Actual)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00168
        • Fondazione Policlinico Universitario A.Gemelli IRCCS
    • RM
      • Roma, RM, Italy, 00168
        • Fondazione Policlinico Universitario A. Gemelli IRCCS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Percentage of HbF at 32 Weeks of Post Menstrual Age
Time Frame: From study entry to the completion of postmenstrual age of 32 weeks
The HbF level was determined by high-performance liquid chromatography and was expressed as percentage of total Hb, calculated as the sum of fetal and adult Hb, according to the formula: HbF= [HbF/ (FHbA1 + HbA2 + HbF)]. HbF.
From study entry to the completion of postmenstrual age of 32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-transfusion Hematocrit (Htc) Change
Time Frame: From enrollment to last HbF assessment occurring at 36 weeks, discharge or death
Change from baseline of Htc observed after either adult-RBC or cord-RBC transfusions. To this purpose, analysis was carried out between the two groups of RBC transfusions and patients were accordingly redistributed.
From enrollment to last HbF assessment occurring at 36 weeks, discharge or death
Intervals Between Transfusions
Time Frame: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death
Number of days between two consecutive transfusions.To this purpose, analysis was carried out between the two groups of RBC transfusions and patients were accordingly redistributed.
From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death
Median Percentage of HbF at Last Assessment
Time Frame: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death
Median percentage of HbF at last HbF assessment. The last HbF measure was obtained at the completion of the 36 week of age, discharge or death.
From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Investigators

  • Principal Investigator: Luciana Teofili, MD, PhD, Fondazione Policlinico Agostino Gemelli IRCCS

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2018

Primary Completion (Actual)

August 2, 2019

Study Completion (Actual)

August 2, 2019

Study Registration Dates

First Submitted

November 22, 2018

First Submitted That Met QC Criteria

December 3, 2018

First Posted (Actual)

December 5, 2018

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

August 16, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22139/18ID:1916

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Premature Infant Disease

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Germany

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe