RBC Irradiation, Anemia and Gut Injury

Anemia Clinical Trial

— RBC-mNIRS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02741648
• Other study ID #: IRB00083691
• Secondary ID: 2P01HL0867731R01
• Status: Recruiting
• Start date: July 2016
• Est. completion date: April 2022

Study information

• Verified date: April 2021
• Source: Emory University
• Contact: Cassandra Josephson, MD
• Phone: 404-785-4553
• Email: cjoseph[@]emory.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: April 2022
• Est. primary completion date: April 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Days

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Enterocolitis
• Enterocolitis, Necrotizing
• Necrotizing Enterocolitis

Intervention

Device:
• Near Infrared Spectroscopy
INVOS 5100C Cerebral/Somatic Oximeter is an FDA-approved device used to measure renal and mesenteric tissue oxygenation, as defined by regional oxygenation saturation levels (rSO2). Two probe site monitoring will be used to evaluate differential tissue bed oxygenation. Adhesive sensor probes are applied to the periumbilical area for mesenteric monitoring and to the flank area for renal monitoring.

Locations

Country	Name	City	State
United States	Emory University Hospital Midtown	Atlanta	Georgia
United States	Grady Memorial Hospital	Atlanta	Georgia
United States	Northside Hospital - Neonatology	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in Mesenteric Tissue Oxygenation	Regional Oxygenation Saturation Levels (rSO2) are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring.	60 Minutes prior to transfusion to 48 hours after transfusion
Primary	Changes in Mesenteric Tissue Oxygenation	ELBW infants that reach the window when NEC typically occurs will be further compared as those with vs without anemia. Regional Oxygenation Saturation Levels (rSO2) are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring. NIRS will be performed once per week (whether transfused or not) for a 48 hour period starting each Monday (day of routine lab draw to evaluate anemia).	Week 30 to Week 34 Post Menstrual Age