Premature Infant DiseaseCB-TrIPNCT03764813
Cord Blood Transfusion In Preterm Neonates (CB-TrIP)
An observational study of Premature Infant Disease and Transfusion Related Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Premature Infant Disease, Transfusion Related Complication, Fetal Hemoglobin
- How many people
- 25 participants
- Where
- 2 sitesItaly
- Study dates
- 5 Dec 2018to 2 Aug 2019
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Italy2 sites
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, RM, 00168
Fondazione Policlinico Universitario A.Gemelli IRCCS
Rome, 00168
About this study
Official title: 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).
Read the 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.
- Medical subject headings
- beta-Thalassemia
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From study entry to the completion of postmenstrual age of 32 weeks
Secondary outcomes (3)
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.
Measured: From enrollment to last HbF assessment occurring at 36 weeks, discharge or death
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.
Measured: 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.
Measured: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2018
- Study start5 Dec 2018
- Primary completion2 Aug 2019
- Study completion2 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Premature Infant DiseaseStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, TEOFILI LUCIANA, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Investigators
- Luciana Teofili, MD, PhD, Principal investigator, Fondazione Policlinico Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764813
- Sponsor's protocol ID
- 22139/18ID:1916
- Acronym
- CB-TrIP
- Status last verified
- Aug 2021
- First submitted
- 22 Nov 2018
- Last updated
- 17 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 30328121Bianchi 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.
PubMed 25401961Stutchfield 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.
PubMed 28548651dos 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.
PubMed 21489555Valieva 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.
PubMed 19732577Teofili 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.
PubMed 32510635
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Hemoglobin Levels and Umbilical Cord or Adult Blood RBC Transfusions in Preterm Neonates.
- ClinicalTrials.gov ID
- NCT03764813
- Acronym / sponsor ID
- CB-TrIP / 22139/18ID:1916
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 2 Aug 2019 (actual)
- Study completion
- 2 Aug 2019 (actual)
- First posted
- 5 Dec 2018 (actual)
- Results
- Posted 24 Apr 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Post-transfusion Hematocrit (Htc) Change
Time frame: 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
Median Percentage of HbF at Last Assessment
Time frame: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or death
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30328121Bianchi 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.
- Background: PubMed 25401961Bianchi 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.
- Background: PubMed 28548651Stutchfield 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.
- Background: PubMed 21489555dos 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.
- Background: PubMed 19732577Valieva 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.
- Derived from this study: PubMed 32510635Teofili 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.
Related trials for Premature Infant Disease
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
Recruiting
Study of the Influence of Intraperitoneal Insufflation of CO2 by Laparoscopy on the Short-term Evolution of Premature Infants With Ulcerative Necrotizing Enterocolitis
Preterm Birth, Enterocolitis, Necrotizing
Recruiting
Comparing Surfactant Administration Through Supraglottic Airway and Thin Catheter for Preterm Infants
Surfactant, Respiratory Distress Syndrome (Neonatal)
Recruiting
Optimization of Saturation Targets And Resuscitation Trial (OptiSTART)
Premature Infants, Bronchopulmonary Dysplasia
RecruitingObservational study
Growing Little PEAPODS Study
Premature Birth, Premature Infant
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luciana Teofili, MD, PhD principal investigator
Fondazione Policlinico Agostino Gemelli IRCCS
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Premature Infant Disease and Transfusion Related Complication, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Apr 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764813, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.