The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 1
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- Magee-Womens Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Singleton infants born at 25-32 weeks gestation who are < 38 weeks post-conceptual age at enrollment
- 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.
- Receiving bolus enteral feeds [PO (bottle) and/or PE (feeding tube)] of at least 60 cc/kg/day
- A planned packed red blood cell transfusion, as per the clinical team, for anemia
- Infant is very likely to require a blood transfusion according to the attending neonatologist.
Exclusion Criteria:
- Known congenital anomalies of the heart, brain, kidneys or intestine
- Chromosomal abnormality
- Intrauterine growth restriction at < 3% for weight at birth since this has been shown to alter mesenteric BFV and the post-prandial hyperemia
- Twin to twin transfusion sequence
- Higher order multiples
- Patent ductus arteriosus known to be present or currently being treated
- History of definite necrotizing enterocolitis Bell Stage 2 or greater
- Concurrent treatments with antibiotics or steroids
- Feeding intolerance, defined as gastric aspirate > 30% of feed volume on 3 sequential feeds
- Concurrent enrollment in another randomized trial
- Infants discharged or transferred to another facility without having received a PRBC transfusion will be excluded post-hoc.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: group 1
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion
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Active Comparator: group 2
Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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No Intervention: group 3
All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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Experimental: group 4
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
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babies receiving the intervention are fed during the PRBC transfusion
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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 Frame: 1 hour
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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
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1 hour
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Gretchen Krimmel, MD, University of Pittsburgh
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0404184
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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