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The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

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ClinicalTrials.gov Identifier: NCT00167388
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Information provided by (Responsible Party):
Toby Yanowitz, University of Pittsburgh

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Condition Anemia of Prematurity
Intervention Other: feed during blood transfusion
Enrollment 22
Recruitment Details recruitment is completed
Pre-assignment Details  
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description <1250 gm at time of study, Fed during PRBC transfusion <1250 gm at time of study, Not fed during PRBC transfusion >1250 gm at time of study, Fed during PRBC transfusion >1250 gm at time of study, Not fed during PRBC transfusion
Period Title: Overall Study
Started 5 5 6 6
Completed Doppler Study 5 5 6 6
Completed 5 5 6 6
Not Completed 0 0 0 0
Arm/Group Title Group 1 Group 2 Group 3 Group 4 Total
Hide Arm/Group Description

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

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

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

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 of all reporting groups
Overall Number of Baseline Participants 5 5 6 6 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
<=18 years
5
 100.0%
5
 100.0%
6
 100.0%
6
 100.0%
22
 100.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
Female
4
  80.0%
4
  80.0%
3
  50.0%
4
  66.7%
15
  68.2%
Male
1
  20.0%
1
  20.0%
3
  50.0%
2
  33.3%
7
  31.8%
Weight at time of study  
Mean (Full Range)
Unit of measure:  Grams
Number Analyzed 5 participants 5 participants 6 participants 6 participants 22 participants
886
(839 to 1248)
736
(696 to 1105)
1752
(1595 to 1945)
1856
(1409 to 2393)
1127
(696 to 2393)
1.Primary Outcome
Title Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Hide Description 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
Time Frame 1 hour
Hide Outcome Measure Data
Hide Analysis Population Description
the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)
Arm/Group Title Groups 1 and 2 Groups 3 and 4
Hide Arm/Group Description:
Infants <1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
Infants >1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
Overall Number of Participants Analyzed 10 12
Mean (Standard Deviation)
Unit of Measure: cm/sec
Mean MBFV Response to feeding when anemic 2.02  (6.15) 5.91  (4.08)
Peak Systolic BFV Response to feeds when anemic 7.66  (14.40) 14.99  (14.97)
Mean MBFV Response to Feeding Post-Transfusion 0.43  (1.91) 3.61  (2.46)
Pk Systolic BFV Response to Feed Post-Transfusio -1.24  (5.53) 15.24  (6.36)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Groups 1 and 2
Comments Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies <1250 gm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.571
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Groups 1 and 2
Comments change in peak systolic blood flow velocity from pre-to post feed for babies <1250 gm while anemic
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.345
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Groups 3 and 4
Comments Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies >1250 gm
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.006
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Groups 3 and 4
Comments change in peak systolic blood flow velocity from pre-to post feed for babies >1250 gm while anemic
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Groups 1 and 2
Comments Change in mean mesenteric blood flow velocity from pre-to post-feed for babies <1250 gm after the PRBC transfusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.910
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Groups 1 and 2
Comments Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies <1250 gm after the PRBC transfusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.850
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Groups 3 and 4
Comments Change in mean mesenteric blood flow velocity from pre-to post-feed for babies >1250 gm after the PRBC transfusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.507
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Show Statistical Analysis 8 Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Groups 3 and 4
Comments Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies >1250 gm after the PRBC transfusion
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.286
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Time Frame 2 weeks
Adverse Event Reporting Description The main adverse event being evaluated was necrotizing enterocolitis. The did not occur in any infant
 
Arm/Group Title Group 1 Group 2 Group 3 Group 4
Hide Arm/Group Description < 1250 gm Fed during the study <1250 gm, not fed during the study >1250 gm, fed during the study >1250 gm, not fed during the study
All-Cause Mortality
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
Group 1 Group 2 Group 3 Group 4
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/5 (0.00%)   0/5 (0.00%)   0/6 (0.00%)   0/6 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Toby Yanowitz
Organization: University of Pittsburgh
Phone: 412-641-4111
EMail: yanotd@mail.magee.edu
Layout table for additonal information
Responsible Party: Toby Yanowitz, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00167388     History of Changes
Other Study ID Numbers: 0404184
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: January 6, 2016
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017