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The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

Primary Purpose

Anemia of Prematurity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
feed during blood transfusion
Sponsored by
University of Pittsburgh
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Anemia of Prematurity focused on measuring anemia, prematurity, blood flow velocity, superior mesenteric artery, intestinal blood flow in premature infants

Eligibility Criteria

25 Weeks - 38 Weeks (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Magee-Womens Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

No Intervention

Experimental

Arm Label

group 1

group 2

group 3

group 4

Arm Description

All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion

Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
September 9, 2005
Last Updated
April 19, 2017
Sponsor
University of Pittsburgh
Collaborators
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00167388
Brief Title
The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Official Title
The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
November 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Pittsburgh
Collaborators
Irene McLeneham Young Investigator Award through Magee Womens Research Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia of Prematurity
Keywords
anemia, prematurity, blood flow velocity, superior mesenteric artery, intestinal blood flow in premature infants

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group 1
Arm Type
No Intervention
Arm Description
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be NPO during the PRBC transfusion
Arm Title
group 2
Arm Type
Active Comparator
Arm Description
Babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
Arm Title
group 3
Arm Type
No Intervention
Arm Description
All babies >1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
Arm Title
group 4
Arm Type
Experimental
Arm Description
All babies <1250 gm at the time of the study are enrolled into this arm, and randomized to be fed during the PRBC transfusion
Intervention Type
Other
Intervention Name(s)
feed during blood transfusion
Intervention Description
babies receiving the intervention are fed during the PRBC transfusion
Primary Outcome Measure Information:
Title
Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Weeks
Maximum Age & Unit of Time
38 Weeks
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen Krimmel, MD
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
Magee-Womens Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants

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