Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00167388
Status:
COMPLETED
Last Update Posted:
2017-07-21
First Post:
2005-09-09
Brief Title:
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of the study is to see if a blood transfusion changes how fast blood flows to the intestines of a premature baby Blood flow is measured by an ultrasound test The investigators also look to see if the blood flow to the intestines depends on whether the baby feeds or doesnt feed during the blood transfusion
Detailed Description:
Currently a disparity exists among the NICU staff at Magee-Womens Hospital regarding whether premature infants should be fed during a blood transfusion The effects of a blood transfusion on superior mesenteric artery blood flow velocity and the post-prandial hyperemia are not known
We hypothesize that the post-prandial change in mesenteric blood flow velocity BFV will be the same before as after a packed red blood cell PRBC transfusion among anemic premature infants
Sixty anemic infants 25-32 weeks GA feeding 60 cckgday will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion Infants will be stratified by current weight into two groups 1250 grams and 1250 grams In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion Randomization will be by block design with block sizes ranging from two to six infants The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants Statistical analysis will include paired and unpaired Student t-tests and regression analysis
We hypothesize that the post-prandial change in mesenteric blood flow velocity BFV will be the same before as after a packed red blood cell PRBC transfusion among anemic premature infants
Sixty anemic infants 25-32 weeks GA feeding 60 cckgday will undergo pre- and post-feed superior mesenteric artery Doppler studies both before and after a blood transfusion Infants will be stratified by current weight into two groups 1250 grams and 1250 grams In each weight stratum the infants will be randomized to feeding or NPO during the PRBC transfusion Randomization will be by block design with block sizes ranging from two to six infants The investigator performing the Doppler studies will remain masked to the feeding assignment of the infant
The primary outcome for the study is the superior mesenteric artery blood flow velocity response to feeding between anemic and non-anemic states among premature infants Our secondary outcome is the effect of feeding on BFV between anemic and non-anemic states in these infants Statistical analysis will include paired and unpaired Student t-tests and regression analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None