Trial Outcomes & Findings for The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants (NCT NCT00167388)
NCT ID: NCT00167388
Last Updated: 2017-07-21
Results Overview
Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
22 participants
Primary outcome timeframe
1 hour
Results posted on
2017-07-21
Participant Flow
recruitment is completed
Participant milestones
| Measure |
Group 1
\<1250 gm at time of study, Fed during PRBC transfusion
|
Group 2
\<1250 gm at time of study, Not fed during PRBC transfusion
|
Group 3
\>1250 gm at time of study, Fed during PRBC transfusion
|
Group 4
\>1250 gm at time of study, Not fed during PRBC transfusion
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
5
|
5
|
6
|
6
|
|
Overall Study
Completed Doppler Study
|
5
|
5
|
6
|
6
|
|
Overall Study
COMPLETED
|
5
|
5
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Baseline characteristics by cohort
| Measure |
Group 1
n=5 Participants
Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight \<1250 at time of study and randomized to "feeding" during the PRBC transfusion
|
Group 2
n=5 Participants
Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight \<1250 at time of study and randomized to "not feeding" during the PRBC transfusion
|
Group 3
n=6 Participants
Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight \>1250 at time of study and randomized to "feeding" during the PRBC transfusion
|
Group 4
n=6 Participants
Infant born at 25-32 weeks GA at Magee Womens Hospital between October 2005 and November 2007 and received a PRBC transfusion.
Weight \>1250 at time of study and randomized to "not feeding" during the PRBC transfusion
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
22 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Weight at time of study
|
886 grams
n=5 Participants
|
736 grams
n=7 Participants
|
1752 grams
n=5 Participants
|
1856 grams
n=4 Participants
|
1127 grams
n=21 Participants
|
PRIMARY outcome
Timeframe: 1 hourPopulation: the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)
Time-averaged mean and Peak systolic Doppler blood flow velocity in the mesenteric artery was measured before and after a feed when the baby was anemic (pre-PRBC transfusion) and then again when the baby was immediately post-transfusion
Outcome measures
| Measure |
Groups 1 and 2
n=10 Participants
Infants \<1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
|
Groups 3 and 4
n=12 Participants
Infants \>1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
|
|---|---|---|
|
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Mean MBFV Response to feeding when anemic
|
2.02 cm/sec
Standard Deviation 6.15
|
5.91 cm/sec
Standard Deviation 4.08
|
|
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Peak Systolic BFV Response to feeds when anemic
|
7.66 cm/sec
Standard Deviation 14.40
|
14.99 cm/sec
Standard Deviation 14.97
|
|
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Mean MBFV Response to Feeding Post-Transfusion
|
0.43 cm/sec
Standard Deviation 1.91
|
3.61 cm/sec
Standard Deviation 2.46
|
|
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Pk Systolic BFV Response to Feed Post-Transfusio
|
-1.24 cm/sec
Standard Deviation 5.53
|
15.24 cm/sec
Standard Deviation 6.36
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place