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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00167388
First Posted: September 14, 2005
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Information provided by (Responsible Party):
Toby Yanowitz, University of Pittsburgh
  Purpose
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.

Condition Intervention Phase
Anemia of Prematurity Other: feed during blood transfusion Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Official Title: The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding

Resource links provided by NLM:


Further study details as provided by Toby Yanowitz, University of Pittsburgh:

Primary Outcome Measures:
  • Change in Superior Mesenteric Artery Blood Flow Velocity From Pre-to-post Feed in the Anemic and the Transfused States [ Time Frame: 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


Enrollment: 22
Study Start Date: September 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
Other: feed during blood transfusion
babies receiving the intervention are fed during the PRBC transfusion
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
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
Other: feed during blood transfusion
babies receiving the intervention are fed during the PRBC 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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Weeks to 38 Weeks   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167388


Locations
United States, Pennsylvania
Magee-Womens Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Investigators
Principal Investigator: Gretchen Krimmel, MD Magee-Womens Hospital
  More Information

Responsible Party: Toby Yanowitz, Assistant Professor of Pediatrics, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00167388     History of Changes
Other Study ID Numbers: 0404184
First Submitted: September 9, 2005
First Posted: September 14, 2005
Results First Submitted: January 6, 2016
Results First Posted: July 21, 2017
Last Update Posted: July 21, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Toby Yanowitz, University of Pittsburgh:
anemia
prematurity
blood flow velocity
superior mesenteric artery
intestinal blood flow in premature infants

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications