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| Name | Class |
|---|---|
| Irene McLeneham Young Investigator Award through Magee Womens Research Institute | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group 1 | No Intervention | All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion | |
| group 2 | Active Comparator | Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
|
| group 3 | No Intervention | All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion | |
| group 4 | Experimental | All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| feed during blood transfusion | Other | babies receiving the intervention are fed during the PRBC transfusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 1 hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Gretchen Krimmel, MD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Magee-Womens Hospital | Pittsburgh | Pennsylvania | 15213 | United States |
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recruitment is completed
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| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | <1250 gm at time of study, Fed during PRBC transfusion |
| FG001 | Group 2 | <1250 gm at time of study, Not fed during PRBC transfusion |
| FG002 | Group 3 | >1250 gm at time of study, Fed during PRBC transfusion |
| FG003 | Group 4 | >1250 gm at time of study, Not fed during PRBC transfusion |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | Group 2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | the number below represents the change in the parameter with feeding while the baby anemic (pre-transfusion) | Posted | Mean | Standard Deviation | cm/sec | 1 hour |
|
2 weeks
The main adverse event being evaluated was necrotizing enterocolitis. The did not occur in any infant
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | < 1250 gm Fed during the study |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Toby Yanowitz | University of Pittsburgh | 412-641-4111 | yanotd@mail.magee.edu |
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| ID | Term |
|---|---|
| D000740 | Anemia |
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
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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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Weight at time of study | Mean | Full Range | grams |
|
Infants >1250 gm, irrespective of whether they were fed or NPO during the PRBC transfusion
|
|
|
| 0 |
| 5 |
| 0 |
| 5 |
| EG001 | Group 2 | <1250 gm, not fed during the study | 0 | 5 | 0 | 5 |
| EG002 | Group 3 | >1250 gm, fed during the study | 0 | 6 | 0 | 6 |
| EG003 | Group 4 | >1250 gm, not fed during the study | 0 | 6 | 0 | 6 |
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| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |