Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 1250 Grams (RBC-mNIRS)

NCT02741648 ACTIVE_NOT_RECRUITING

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.

Details

Lead sponsor	Emory University
Status	ACTIVE_NOT_RECRUITING
Enrolment	324
Start date	2016-07
Completion	2026-02-28

Conditions

• Anemia
• Necrotizing Enterocolitis

Interventions

• Near Infrared Spectroscopy
• Non-invasive Image-based Anemia Assessment

Primary outcomes

• Mesenteric Tissue Oxygenation — 60 Minutes prior to transfusion to 48 hours after transfusion
  Mesenteric tissue oxygenation is measured in infants receiving RBC transfusion. Mesenteric regional saturation of oxygen (MES-rSO2) levels are measured via the INVOS 5100C Cerebral/Somatic Oximeter by applying an adhesive sensor probe to the patient's periumbilical area for mesenteric monitoring. MES-rSO2 will be compared between infants receiving RBC transfusion with and without IST.
• Infants Developing TR-NEC — 60 Minutes prior to transfusion to 48 hours after transfusion
  Development of TR-NEC will be compared between infants receiving RBC transfusion with and without IST.
• Inhibition of NO-Mediated Vasodilation — 60 Minutes prior to transfusion to 48 hours after transfusion
  Inhibition of NO-mediated vasodilation will be used to assess RBC function among transfused infants who develop TR-NEC and matched control infants who do not develop TR-NEC.
• Metabolic Changes of Red Blood Cells — 60 Minutes prior to transfusion to 48 hours after transfusion
  Functional defects of transfused RBCs will be examined to assess metabolic changes of RBCs among transfused infants who develop TR-NEC and matched control infants who do not develop TR-NEC.
• Mesenteric Tissue Oxygenation During the NEC Window Period — 28 to 34 Weeks Post Menstrual Age
  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).
• Immune Cell Function — Up to 90 days of age
  Anemia significantly modulates immune function and may predispose infants to NEC through alterations in T cell activation and the presence of immunomodulatory erythroid precursors. Immune cell function profiles will be compared between infants who develop TR-NEC and matched controls who do not.

Countries

United States