Cord Blood Transfusion In Preterm Neonates (CB-TrIP)

NCT03764813 | Completed Results DMC

• 1 other identifier: 22139/18ID:1916
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 2

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).

Conditions

Premature Infant Disease; Transfusion Related Complication; Fetal Hemoglobin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Post-transfusion Hematocrit (Htc) Change

  From enrollment to last HbF assessment occurring at 36 weeks, discharge or death

• Intervals Between Transfusions

  From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death

• Median Percentage of HbF at Last Assessment

  From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (2)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, RM, 00168, Italy

Location

Fondazione Policlinico Universitario A.Gemelli IRCCS

Rome, 00168, Italy

Location

Related Publications (6)

• 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.

  PMID: 30328121 BACKGROUND

• 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.

  PMID: 25401961 BACKGROUND

• 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.

  PMID: 28548651 BACKGROUND

• 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.

  PMID: 21489555 BACKGROUND

• 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.

  PMID: 19732577 BACKGROUND

• Teofili L, Papacci P, Orlando N, Bianchi M, Molisso A, Purcaro V, Valentini CG, Giannantonio C, Serrao F, Chiusolo P, Nicolotti N, Pellegrino C, Carducci B, Vento G, De Stefano V. Allogeneic cord blood transfusions prevent fetal haemoglobin depletion in preterm neonates. Results of the CB-TrIP study. Br J Haematol. 2020 Oct;191(2):263-268. doi: 10.1111/bjh.16851. Epub 2020 Jun 8.

  PMID: 32510635 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

80-100 microL of capillary blood for HbF assessment

MeSH Terms

Conditions

beta-Thalassemia

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Results Point of Contact

• Title: luciana teofilili medical director of the UNICATT cord blood bank
• Organization: Fondazione Policlinico Gemelli IRCCS

luciana.teofili@unicatt.it

39 06 30154180

Study Officials

• Luciana Teofili, MD, PhD

  Fondazione Policlinico Agostino Gemelli IRCCS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director of the UNICATT Cord Blood Bank

Study Record Dates

• First Submitted: November 22, 2018
• First Posted: December 5, 2018
• Study Start: December 5, 2018
• Primary Completion: August 2, 2019
• Study Completion: August 2, 2019
• Last Updated: August 17, 2021
• Results First Posted: April 24, 2020

Record last verified: 2021-08

Locations

IT (2)