Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

Transfusion Related Complication Clinical Trial

— CB-TrIP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764813
• Other study ID #: 22139/18ID:1916
• Status: Completed
• Start date: December 5, 2018
• Est. completion date: August 2, 2019

Study information

• Verified date: August 2021
• Source: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: August 2, 2019
• Est. primary completion date: August 2, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Fetal Hemoglobin
• Infant, Premature, Diseases
• Premature Infant Disease
• Transfusion Related Complication

Locations

Country	Name	City	State
Italy	Fondazione Policlinico Universitario A. Gemelli IRCCS	Roma	RM
Italy	Fondazione Policlinico Universitario A.Gemelli IRCCS	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Country where clinical trial is conducted

Italy, 

References & Publications (5)

Bianchi M, Giannantonio C, Spartano S, Fioretti M, Landini A, Molisso A, Tesfagabir GM, Tornesello A, Barbagallo O, Valentini CG, Vento G, Zini G, Romagnoli C, Papacci P, Teofili L. Allogeneic umbilical cord blood red cell concentrates: an innovative blood product for transfusion therapy of preterm infants. Neonatology. 2015;107(2):81-6. doi: 10.1159/000368296. Epub 2014 Nov 15. — View Citation

Bianchi M, Papacci P, Valentini CG, Barbagallo O, Vento G, Teofili L. Umbilical cord blood as a source for red-blood-cell transfusion in neonatology: a systematic review. Vox Sang. 2018 Nov;113(8):713-725. doi: 10.1111/vox.12720. Epub 2018 Oct 16. — View Citation

dos Santos AM, Guinsburg R, de Almeida MF, Procianoy RS, Leone CR, Marba ST, Rugolo LM, Fiori HH, Lopes JM, Martinez FE; Brazilian Network on Neonatal Research. Red blood cell transfusions are independently associated with intra-hospital mortality in very low birth weight preterm infants. J Pediatr. 2011 Sep;159(3):371-376.e1-3. doi: 10.1016/j.jpeds.2011.02.040. Epub 2011 Apr 13. — View Citation

Stutchfield CJ, Jain A, Odd D, Williams C, Markham R. Foetal haemoglobin, blood transfusion, and retinopathy of prematurity in very preterm infants: a pilot prospective cohort study. Eye (Lond). 2017 Oct;31(10):1451-1455. doi: 10.1038/eye.2017.76. Epub 2017 May 26. — View Citation

Valieva OA, Strandjord TP, Mayock DE, Juul SE. Effects of transfusions in extremely low birth weight infants: a retrospective study. J Pediatr. 2009 Sep;155(3):331-37.e1. doi: 10.1016/j.jpeds.2009.02.026. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Percentage of HbF at 32 Weeks of Post Menstrual Age	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	Post-transfusion Hematocrit (Htc) Change	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
Secondary	Intervals Between Transfusions	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
Secondary	Median Percentage of HbF at Last Assessment	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