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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).
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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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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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.
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| Name | Affiliation | Role |
|---|---|---|
| Luciana Teofili, MD, PhD | Fondazione Policlinico Agostino Gemelli IRCCS | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fondazione Policlinico Universitario A. Gemelli IRCCS | Roma | RM | 00168 | Italy | ||
| Fondazione Policlinico Universitario A.Gemelli IRCCS |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30328121 | Background | 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. | |
| 25401961 | 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. |
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Among 29 couples, 25 accepted to participate and overall 25 patients were enrolled.
Parents of neonates with birth weight < 1000 gr and/or postmenstrual age < 30 weeks consecutively admitted to the intensive neonatal unit of Fondazione Poiliclinico Gemelli IRCCS were informed about the study and asked to paricipate.
| ID | Title | Description |
|---|---|---|
| FG000 | Non Transfused | Patient not receiving transfusions |
| FG001 | Cord-RBC Transfusions | Patients receiving exclusively allogeneic top up transfusions obtained from healthy full term neonates. |
| FG002 | Adult-RBC Transfusion | Patients receiving exclusively standard RBC transfusions from adult donors |
| FG003 | Cord- and Adult-RBC Transfusions | Patients receiving both types of transfusions |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| From Enrollment to the Age of 32 Weeks |
|
| ||||||||||||||||||
| From Enrollment to the Last HbF Test |
|
These data refer to all patients enrolled in the study, grouped according types of transfusions received (if any) until the completion of the age of 36 weeks, discharge or death.
| ID | Title | Description |
|---|---|---|
| BG000 | Non-Transfused | 13 patients not receiving transfusions. |
| BG001 | Only Cord-RBC | 3 patients receiving exclusively cord-RBC transfusions |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Gestational age at birth (weeks) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | The overall amount of 264 HbF results were included in the analysis. HbF was expressed as percentage of total Hb (i.e. HbF+HbA1+HbA2) | Posted | Median | Inter-Quartile Range | percentage of total Hb | From study entry to the completion of postmenstrual age of 32 weeks | HbF values | HbF values |
|
From enrollment to postmenstrual age of 36 weeks.
All cause mortality
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Non-transfused | 13 preterm neonates non receiving transfusions | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| documented infections | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| luciana teofilili medical director of the UNICATT cord blood bank | Fondazione Policlinico Gemelli IRCCS | 39 06 30154180 | luciana.teofili@unicatt.it |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 2, 2018 | Feb 28, 2020 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D017086 | beta-Thalassemia |
| ID | Term |
|---|---|
| D013789 | Thalassemia |
| D000745 | Anemia, Hemolytic, Congenital |
| D000743 | Anemia, Hemolytic |
| D000740 | Anemia |
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80-100 microL of capillary blood for HbF assessment
| 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 |
| 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 |
| Rome |
| 00168 |
| Italy |
| 28548651 | 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. |
| 21489555 | 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. |
| 19732577 | 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. |
| 32510635 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
|
| BG002 | Only Adult-RBC | 4 patients receiving exclusively adult-RBC transfusions |
| BG003 | Cord- and Adult-RBC | 5 patients receiving both adult-RBC and cord-RBC transfusions |
| BG004 | Total | Total of all reporting groups |
| HbF measures |
|
| Median |
| Inter-Quartile Range |
| weeks |
| Participants |
|
|
| Sex: Female, Male | Count of Participants | Participants | Participants |
|
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants | Participants |
|
|
| Birth weight | Weight at birth | Median | Inter-Quartile Range | grams | Participants |
|
|
| Hb at birth | Hemoglobin at birth (g/dL) | Median | Inter-Quartile Range | g/dL | Participants |
|
|
| Only Cord-RBC |
19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions |
| OG002 | Only adult_RBC | 33 HbF measures obtained from 3 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only adult-RBC transfusions |
| OG003 | Both Cord-RBC and adult_RBC | 85 HbF measures obtained from 5 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving both cord-RBC and adult-RBC transfusions |
|
|
|
| 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. | Eight patients received 13 cord-RBC units and 9 patients received 18 adult-RBC units. Change of hematocrit value after each transfusion was recorded. | Posted | Median | Inter-Quartile Range | percentage of total volume | From enrollment to last HbF assessment occurring at 36 weeks, discharge or death | number of transfusions | number of transfusions |
|
|
|
|
| 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. | Eight patients received a total number of 13 cord-RBC trasfusions and 9 patients received a total number of 18 adult -RBC transfusions. The intervals between two consecutive transfusions was recorded for each type of RBC unit. | Posted | Median | Inter-Quartile Range | days | From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death | number of transfusions | number of transfusions |
|
|
|
|
| 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. | Data recorded in all patient enetering the study were included in the analysis. Patients were grouped according to the type of RBC receved. | Posted | Median | Inter-Quartile Range | % HbF | From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death | median HbF (%) | median HbF (%) |
|
|
|
|
| 13 |
| 1 |
| 13 |
| 0 |
| 13 |
| EG001 | Only Cord-TBC | 3 neonates receiving only cord-RBC | 1 | 3 | 3 | 3 | 0 | 3 |
| EG002 | Only Adult-RBC | 4 neonates receiving only adult-RBC | 1 | 4 | 3 | 4 | 0 | 4 |
| EG003 | Both Cord- and Adult-RBC | 5 neonates receiving both RBC types | 0 | 5 | 5 | 5 | 0 | 5 |
| Retinopathy stage II-III | Eye disorders | Systematic Assessment |
|
| Necrotizing enterocolitis | Gastrointestinal disorders | Systematic Assessment |
|
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| D006402 |
| Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006453 | Hemoglobinopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| Male |
|
| median HbF (%) |
|