The Effect of Blood Transfusion on Blood Flow to the Intestines of Premature Infants - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	Irene McLeneham Young Investigator Award through Magee Womens Research Institute
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00167388

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	Procedure: feed during blood transfusion Procedure: nothing by mouth (NPO) during blood transfusion	Phase I

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Anemia Blood Transfusion and Donation Premature Babies

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Change in superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic versus transfused state

Secondary Outcome Measures:

Effect of feeding versus NPO during transfusion on the change in superior mesenteric artery blood flow velocity from pre-to-post feed in the anemic versus transfused state

Estimated Enrollment:	80
Study Start Date:	September 2005
Study Completion Date:	November 2006

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

Ages Eligible for Study:	25 Weeks to 38 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Study ID Numbers:	0404184
Study First Received:	September 9, 2005
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00167388 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

anemia
prematurity
blood flow velocity
superior mesenteric artery
intestinal blood flow in premature infants

Additional relevant MeSH terms:

Hematologic Diseases
Anemia
Infant, Newborn, Diseases
Infant, Premature, Diseases
Anemia, Neonatal

ClinicalTrials.gov processed this record on February 08, 2010