RBC Irradiation, Anemia and Gut Injury



Status:Recruiting
Conditions:Colitis, Anemia, Gastrointestinal
Therapuetic Areas:Gastroenterology, Hematology
Healthy:No
Age Range:Any
Updated:8/4/2018
Start Date:July 2016
End Date:December 2020
Contact:Cassandra Josephson, MD
Email:cjoseph@emory.edu
Phone:404-785-4553

Use our guide to learn which trials are right for you!

Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants 1250 Grams

The purpose of this trial is to study the effect that anemia and Red Blood Cell (RBC)
transfusions have on oxygen levels in the digestive tracts of Extremely Low Birth Weight
(ELBW) infants and to look for possible markers in a baby's blood, urine and/or stool that
may lead to a better understanding of what makes an ELBW infant at risk for digestive tract
problems such as necrotizing enterocolitis.

Anemia and digestive tract complications are common problems in Extremely Low Birth Weight
infants. Anemia is a condition in which the body does not have enough red blood cells (RBC).
RBCs are important because they contain hemoglobin, the substance that carries oxygen
throughout the body. Transfusions of RBCs in these infants is frequently required to correct
the anemia. Oxygen levels in the digestive tract will be measured before, during and after
each blood transfusion using a tissue oxygen monitor called Near Infrared Spectroscopy
(NIRS). By using this technology, better understanding can be obtained of intestinal blood
flow patterns.

In addition, ELBW infants are more likely to have immature digestive systems and are at risk
for digestive tract problems such as necrotizing enterocolitis (NEC). NEC is a disease
characterized by infection and decreased blood flow to the intestines. NEC is a major cause
of devastating illness and death in this vulnerable preterm population. Leftover blood
samples, urine, stool, and breast milk samples will be collected, frozen, and stored. In the
event a baby develops a digestive tract complication they will be studied in a laboratory to
identify markers that indicate a healthy digestive tract versus illness.

Inclusion Criteria:

- Birth weight ≤1250 grams

- Postnatal age within 7 days of birth

Exclusion Criteria:

- Infant not expected to live beyond 7 days of life based on assessment of treating
neonatologist;

- Severe congenital abnormality expected to affect life expectancy;

- RBC or platelet transfusion at an outside institution occurring prior to screening;

- Maternal refusal to participate.
We found this trial at
3
sites
550 Peachtree St NE
Atlanta, Georgia 30308
(404) 686-4411
Principal Investigator: Cassandra Josephson, MD
Phone: 404-785-4553
Emory University Hospital Midtown Emory University Hospital Midtown is a 511-bed community-based, acute care teaching...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
Atlanta, Georgia 30342
Phone: 404-785-4553
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
80 Jesse Hill Jr Dr SE
Atlanta, Georgia 30303
(404) 616-1000
Principal Investigator: Cassandra Josephson, MD
Phone: 404-785-4553
Grady Memorial Hospital Grady is an internationally recognized teaching hospital staffed exclusively by doctors from...
?
mi
from
Atlanta, GA
Click here to add this to my saved trials