Trial Outcomes & Findings for Cord Blood Transfusion In Preterm Neonates (CB-TrIP) (NCT NCT03764813)
NCT ID: NCT03764813
Last Updated: 2021-08-17
Results Overview
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.
COMPLETED
25 participants
From study entry to the completion of postmenstrual age of 32 weeks
2021-08-17
Participant Flow
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.
Among 29 couples, 25 accepted to participate and overall 25 patients were enrolled.
Unit of analysis: HbF measures
Participant milestones
| Measure |
Non Transfused
Patient not receiving transfusions
|
Cord-RBC Transfusions
Patients receiving exclusively allogeneic top up transfusions obtained from healthy full term neonates.
|
Adult-RBC Transfusion
Patients receiving exclusively standard RBC transfusions from adult donors
|
Cord- and Adult-RBC Transfusions
Patients receiving both types of transfusions
|
|---|---|---|---|---|
|
From Enrollment to the Age of 32 Weeks
STARTED
|
14 127
|
3 27
|
4 38
|
4 85
|
|
From Enrollment to the Age of 32 Weeks
COMPLETED
|
14 127
|
2 19
|
3 33
|
4 85
|
|
From Enrollment to the Age of 32 Weeks
NOT COMPLETED
|
0 0
|
1 8
|
1 5
|
0 0
|
|
From Enrollment to the Last HbF Test
STARTED
|
13 224
|
3 46
|
4 68
|
5 140
|
|
From Enrollment to the Last HbF Test
COMPLETED
|
13 224
|
3 46
|
4 68
|
5 140
|
|
From Enrollment to the Last HbF Test
NOT COMPLETED
|
0 0
|
0 0
|
0 0
|
0 0
|
Reasons for withdrawal
| Measure |
Non Transfused
Patient not receiving transfusions
|
Cord-RBC Transfusions
Patients receiving exclusively allogeneic top up transfusions obtained from healthy full term neonates.
|
Adult-RBC Transfusion
Patients receiving exclusively standard RBC transfusions from adult donors
|
Cord- and Adult-RBC Transfusions
Patients receiving both types of transfusions
|
|---|---|---|---|---|
|
From Enrollment to the Age of 32 Weeks
Death before the age of 32 weeks
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Non-Transfused
n=224 HbF measures
13 patients not receiving transfusions.
|
Only Cord-RBC
n=46 HbF measures
3 patients receiving exclusively cord-RBC transfusions
|
Only Adult-RBC
n=68 HbF measures
4 patients receiving exclusively adult-RBC transfusions
|
Cord- and Adult-RBC
n=140 HbF measures
5 patients receiving both adult-RBC and cord-RBC transfusions
|
Total
n=478 HbF measures
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30.0 weeks
n=13 Participants
|
29.3 weeks
n=3 Participants
|
28.5 weeks
n=4 Participants
|
26.4 weeks
n=5 Participants
|
29.4 weeks
n=25 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=13 Participants
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=5 Participants
|
12 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=13 Participants
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=5 Participants
|
13 Participants
n=25 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Birth weight
|
1285 grams
n=13 Participants
|
710 grams
n=3 Participants
|
1070 grams
n=4 Participants
|
930 grams
n=5 Participants
|
1030 grams
n=25 Participants
|
|
Hb at birth
|
17.3 g/dL
n=13 Participants
|
16.3 g/dL
n=3 Participants
|
14.9 g/dL
n=4 Participants
|
14.2 g/dL
n=5 Participants
|
15.4 g/dL
n=25 Participants
|
PRIMARY outcome
Timeframe: From study entry to the completion of postmenstrual age of 32 weeksPopulation: 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)
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.
Outcome measures
| Measure |
Non-transfused
n=127 HbF values
127 HbF measures obtained from 13 preterm neonates surviving until the completion of postmenstrual age of 32 weeks without receiving transfusions
|
Only Cord-RBC
n=19 HbF values
19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions
|
Only adult_RBC
n=33 HbF values
33 HbF measures obtained from 3 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only adult-RBC transfusions
|
Both Cord-RBC and adult_RBC
n=85 HbF values
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
|
|---|---|---|---|---|
|
Median Percentage of HbF at 32 Weeks of Post Menstrual Age
|
93.2 percentage of total Hb
Interval 91.9 to 93.9
|
90.8 percentage of total Hb
Interval 85.7 to 93.7
|
58.0 percentage of total Hb
Interval 51.0 to 93.5
|
69.0 percentage of total Hb
Interval 47.3 to 93.5
|
SECONDARY outcome
Timeframe: From enrollment to last HbF assessment occurring at 36 weeks, discharge or deathPopulation: Eight patients received 13 cord-RBC units and 9 patients received 18 adult-RBC units. Change of hematocrit value after each transfusion was recorded.
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.
Outcome measures
| Measure |
Non-transfused
n=13 number of transfusions
127 HbF measures obtained from 13 preterm neonates surviving until the completion of postmenstrual age of 32 weeks without receiving transfusions
|
Only Cord-RBC
n=18 number of transfusions
19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions
|
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
|
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
|
|---|---|---|---|---|
|
Post-transfusion Hematocrit (Htc) Change
|
9.0 percentage of total volume
Interval 6.5 to 12.0
|
11.5 percentage of total volume
Interval 7.7 to 16.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or deathPopulation: 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.
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.
Outcome measures
| Measure |
Non-transfused
n=13 number of transfusions
127 HbF measures obtained from 13 preterm neonates surviving until the completion of postmenstrual age of 32 weeks without receiving transfusions
|
Only Cord-RBC
n=18 number of transfusions
19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions
|
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
|
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
|
|---|---|---|---|---|
|
Intervals Between Transfusions
|
8.0 days
Interval 5.0 to 18.5
|
7.0 days
Interval 3.0 to 14.0
|
—
|
—
|
SECONDARY outcome
Timeframe: From enrollment to the last HbF assessment occurring at 36 weeks, discharge or deathPopulation: Data recorded in all patient enetering the study were included in the analysis. Patients were grouped according to the type of RBC receved.
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.
Outcome measures
| Measure |
Non-transfused
n=224 median HbF (%)
127 HbF measures obtained from 13 preterm neonates surviving until the completion of postmenstrual age of 32 weeks without receiving transfusions
|
Only Cord-RBC
n=46 median HbF (%)
19 HbF measures obtained from 2 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only cord-RBC transfusions
|
Only adult_RBC
n=68 median HbF (%)
33 HbF measures obtained from 3 preterm neonates surviving until the completion of postmenstrual age of 32 weeks,receiving only adult-RBC transfusions
|
Both Cord-RBC and adult_RBC
n=140 median HbF (%)
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
|
|---|---|---|---|---|
|
Median Percentage of HbF at Last Assessment
|
92.3 % HbF
Interval 91.0 to 93.4
|
90.6 % HbF
Interval 85.6 to 93.6
|
53.6 % HbF
Interval 48.8 to 92.7
|
62.0 % HbF
Interval 47.4 to 92.3
|
Adverse Events
Non-transfused
Only Cord-TBC
Only Adult-RBC
Both Cord- and Adult-RBC
Serious adverse events
| Measure |
Non-transfused
n=13 participants at risk
13 preterm neonates non receiving transfusions
|
Only Cord-TBC
n=3 participants at risk
3 neonates receiving only cord-RBC
|
Only Adult-RBC
n=4 participants at risk
4 neonates receiving only adult-RBC
|
Both Cord- and Adult-RBC
n=5 participants at risk
5 neonates receiving both RBC types
|
|---|---|---|---|---|
|
Infections and infestations
documented infections
|
0.00%
0/13 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
33.3%
1/3 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
25.0%
1/4 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
60.0%
3/5 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
|
Eye disorders
Retinopathy stage II-III
|
7.7%
1/13 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
33.3%
1/3 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
25.0%
1/4 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
80.0%
4/5 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
|
Gastrointestinal disorders
Necrotizing enterocolitis
|
0.00%
0/13 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
33.3%
1/3 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
50.0%
2/4 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
60.0%
3/5 • From enrollment to postmenstrual age of 36 weeks.
All cause mortality
|
Other adverse events
Adverse event data not reported
Additional Information
luciana teofilili medical director of the UNICATT cord blood bank
Fondazione Policlinico Gemelli IRCCS
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place