Anemia of Prematurity
Conditions
Keywords
anemia, prematurity, blood flow velocity, superior mesenteric artery, intestinal blood flow in premature infants
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 doesn't 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 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.
Interventions
OTHERfeed during blood transfusion
babies receiving the intervention are fed during the PRBC transfusion
Sponsors
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
25 Weeks to 38 Weeks
Healthy volunteers
No
Inclusion criteria
1. Singleton infants born at 25-32 weeks gestation who are \< 38 weeks post-conceptual age at enrollment 2. First infant of twin gestation born at 25-32 weeks gestation who requires a blood transfusion; if both infants require transfusion on the same day the larger infant will be enrolled. 3. Receiving bolus enteral feeds \[PO (bottle) and/or PE (feeding tube)\] of at least 60 cc/kg/day 4. A planned packed red blood cell transfusion, as per the clinical team, for anemia 5. Infant is very likely to require a blood transfusion according to the attending neonatologist.
Exclusion criteria
1. Known congenital anomalies of the heart, brain, kidneys or intestine 2. Chromosomal abnormality 3. Intrauterine growth restriction at \< 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia 4. Twin to twin transfusion sequence 5. Higher order multiples 6. Patent ductus arteriosus known to be present or currently being treated 7. History of definite necrotizing enterocolitis Bell Stage 2 or greater 8. Concurrent treatments with antibiotics or steroids 9. Feeding intolerance, defined as gastric aspirate \> 30% of feed volume on 3 sequential feeds 10. Concurrent enrollment in another randomized trial 11. Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States | 1 hour | 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 |
Countries
United States
Participant flow
Recruitment details
recruitment is completed
Participants by arm
| Arm | Count |
|---|---|
| Group 1 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 | 5 |
| Group 2 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 | 5 |
| Group 3 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 | 6 |
| Group 4 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 | 6 |
| Total | 22 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Group 4 | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 5 Participants | 5 Participants | 6 Participants | 6 Participants | 22 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 4 Participants | 4 Participants | 3 Participants | 4 Participants | 15 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 3 Participants | 2 Participants | 7 Participants |
| Weight at time of study | 886 grams | 736 grams | 1752 grams | 1856 grams | 1127 grams |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 5 | 0 / 5 | 0 / 6 | 0 / 6 |
Outcome results
Primary
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
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
Population: the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Groups 1 and 2 | 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 |
| Groups 1 and 2 | 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 14.4 |
| Groups 1 and 2 | 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 |
| Groups 1 and 2 | 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 |
| Groups 3 and 4 | 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 | 15.24 cm/sec | Standard Deviation 6.36 |
| Groups 3 and 4 | 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 | 5.91 cm/sec | Standard Deviation 4.08 |
| Groups 3 and 4 | 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 | 3.61 cm/sec | Standard Deviation 2.46 |
| Groups 3 and 4 | 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 | 14.99 cm/sec | Standard Deviation 14.97 |
Comparison: Change in mean mesenteric blood flow velocity from pre- to post- feed in the anemic state for babies \<1250 gmp-value: 0.571Wilcoxon (Mann-Whitney)
Comparison: change in peak systolic blood flow velocity from pre-to post feed for babies \<1250 gm while anemicp-value: 0.345Wilcoxon (Mann-Whitney)
Comparison: Change in superior mesenteric artery blood flow velocity from pre- to post- feed in the anemic state for babies \>1250 gmp-value: 0.006Wilcoxon (Mann-Whitney)
Comparison: change in peak systolic blood flow velocity from pre-to post feed for babies \>1250 gm while anemicp-value: 0.035Wilcoxon (Mann-Whitney)
Comparison: Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusionp-value: 0.91Wilcoxon (Mann-Whitney)
Comparison: Change in Peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \<1250 gm after the PRBC transfusionp-value: 0.85Wilcoxon (Mann-Whitney)
Comparison: Change in mean mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusionp-value: 0.507Wilcoxon (Mann-Whitney)
Comparison: Change in peak systolic mesenteric blood flow velocity from pre-to post-feed for babies \>1250 gm after the PRBC transfusionp-value: 0.286Wilcoxon (Mann-Whitney)