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

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ClinicalTrials.gov Identifier: NCT00167388
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : July 21, 2017
Last Update Posted : July 21, 2017
Sponsor:
Collaborator:
Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Information provided by (Responsible Party):
Toby Yanowitz, University of Pittsburgh

Tracking Information
First Submitted Date  ICMJE September 9, 2005
First Posted Date  ICMJE September 14, 2005
Results First Submitted Date  ICMJE January 6, 2016
Results First Posted Date  ICMJE July 21, 2017
Last Update Posted Date July 21, 2017
Study Start Date  ICMJE September 2005
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Change in Superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic vs transfused state
Change History Complete list of historical versions of study NCT00167388 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: September 12, 2005)
Effect of feeding vs NPO during transfusion on the Change in Superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic vs transfused state
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants
Official Title  ICMJE The Effect of Packed Red Blood Cell Transfusion on Superior Mesenteric Artery Blood Flow Velocity in Premature Infants After Feeding
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE Anemia of Prematurity
Intervention  ICMJE Other: feed during blood transfusion
babies receiving the intervention are fed during the PRBC transfusion
Study Arms  ICMJE
  • 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
    Intervention: Other: feed during blood 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
    Intervention: Other: feed during blood transfusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 19, 2017)
22
Original Enrollment  ICMJE
 (submitted: September 12, 2005)
80
Actual Study Completion Date  ICMJE November 2006
Actual Primary Completion Date November 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 25 Weeks to 38 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00167388
Other Study ID Numbers  ICMJE 0404184
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Toby Yanowitz, University of Pittsburgh
Study Sponsor  ICMJE University of Pittsburgh
Collaborators  ICMJE Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Investigators  ICMJE
Principal Investigator: Gretchen Krimmel, MD University of Pittsburgh
PRS Account University of Pittsburgh
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP