Anemia of Prematurity Clinical Trial
Official title:
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
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 doesn't feed during the blood transfusion.
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 cc/kg/day) 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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention
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