AnemiaRBC-mNIRSNCT02741648
RBC Irradiation, Anemia and Gut Injury
An observational study of Anemia and Necrotizing Enterocolitis, run by Emory University at 3 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 1 day to 5 days
- Conditions the study is for
- Anemia, Necrotizing Enterocolitis
- What is being tested?
- Near Infrared Spectroscopy and Non-invasive Image-based Anemia Assessment
- Type of treatment
- Medical device
- How many people
- 324 participants
- Where
- 3 sitesUnited States
- Study dates
- Jul 2016to 19 Feb 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 5 days
- All sexes
- No healthy volunteers
- Child
Study population: Extremely low birth weight newborn infants born at Emory University Hospital Midtown, Grady Health System, and Northside Hospital Neonatology. Infants will be followed at Children's Healthcare of Atlanta.
Who may be able to join
- Birth weight ≤1250 grams
- Postnatal age within 7 days of birth
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Grady Memorial Hospital
Atlanta, Georgia, 30303
Emory University Hospital Midtown
Atlanta, Georgia, 30308
Northside Hospital - Neonatology
Atlanta, Georgia, 30342
About this study
Official title: Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 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.
Read the detailed description
Necrotizing Enterocolitis (NEC) is a leading cause of neonatal morbidity and mortality in preterm infants. To date, no effective genetic or clinical markers exist to predict which premature infant will develop NEC, limiting targeted prevention strategies. 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.
Multiple observational studies have reported an association between the exposure to red blood cell (RBC) transfusion and the subsequent development of transfusion related-NEC (TR-NEC).However, no clinical studies have investigated the underlying pathophysiologic mechanisms of TR-NEC. In adults, prolonged RBC storage prior to transfusion has been associated with adverse outcomes and may also contribute to TR-NEC. However, the chronological storage age of blood may not be an accurate gauge of donor RBC function; irradiation of RBCs to prevent transfusion-associated graft-vs-host disease may also contribute to TR-NEC. Currently, the duration considered safe for RBC storage following irradiation (irradiation storage time (IST)) is unclear. Given the multifactorial etiology of NEC, preventative efforts will be more successful if clinicians understand the underlying pathophysiologic mechanisms and modifiable risk factors.
In this study the researchers will conduct a multicenter observational cohort study of very preterm (VPT) infants weighing ≤1250g at birth to prospectively investigate the associations between RBC transfusion, digestive tract oxygenation, and TR-NEC. The overarching hypothesis for this study is that irradiation of RBC units followed by prolonged storage perturbs RBC metabolism and function, and these derangements are associated with paradoxical microvascular vasoconstriction, tissue hypoxia and TR-NEC in transfused infants with already impaired gut oxygenation due to significant anemia. All RBC units transfused to VPT infants throughout the study will be stored based on current standard operating procedures per local site blood banking practices. There will be no study-specific approaches to transfusions or transfusion thresholds, and the decision to transfusion will be made as part of current clinical care by the treating clinicians. No study-specific blood draws will occur and all samples will be obtained from residual samples collected for clinical care that are to be discarded.
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, the researchers intend to better understand intestinal blood flow patterns. RBC function in RBC products transfused to infants will be compared between the infants who develop TR-NEC and matched control infants who do not develop TR-NEC. The researchers will explore the clinical implications of severe anemia when infants are 28 to 34 weeks of postmenstrual age, which is when infants are vulnerable to NEC.
Currently, there are no inexpensive, simple, patient/healthcare provider-operated hemoglobin tests available for diagnosing and assessing the degree of anemia without the use of a blood draw. To that end, Emory investigators have recently developed an algorithm that enables patients/healthcare providers to check if a patient is anemic by simply taking a picture of their fingernail beds on a Smartphone, and running the algorithm on a computer using MATLAB. These studies have shown that the degree of pallor in the fingernail beds, correlates with physiologic levels of hemoglobin in the blood and determines whether or not the patient is anemic. To date, the accuracy of this device has only been tested on adults and older children. Having an accurate and noninvasive means of testing for anemia in VPT infants would reduce the number of blood draws required, decrease the common side effects of phlebotomy, transfusion of RBCs, and would potentially be more cost-effective. As an additional study aim, the researchers of this study seek to develop a new image analysis algorithm (IAA) to predict hemoglobin level and anemia status from fingernail photos. The fingernail beds of VPT infants are extremely small and therefore it is uncertain if the nail bed is the most accurate site to assess anemia in these infants. To determine which site is most accurate in this population pictures will be taken of the fingernail beds, the toe nail beds, the palm of the hand and the sole of the foot with be photographed and analyzed.
Leftover samples of blood, urine, stool, and breast milk will be frozen, and stored and in the event a baby develops a digestive tract complication the samples will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness. Immune cell function, digestive tract microbial changes, and serum cytokine levels will be compared between very preterm infants who develop NEC and those who do not.
- Conditions
- Anemia, Necrotizing Enterocolitis
- Being tested
- Near Infrared Spectroscopy, Non-invasive Image-based Anemia Assessment
- Keywords
- Red Blood Cell Transfusion, Digestive tract problems, Extremely Low Birth Weight
- Medical subject headings
- Anemia, Enterocolitis, Necrotizing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Near Infrared SpectroscopyDevice
Also called NIRS
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.
Non-invasive Image-based Anemia AssessmentOther
A trained research associate will take 2 images (one with the camera flash on and one with the camera flash off) of the patient's fingernail beds, toe nail beds, palm of the hand and sole of the foot. Images will be taken within 24 hours, preceding, or following, each complete blood count (CBC) collection on each consented patient. The anemia diagnosing algorithm will then be run on the images.
| Study group | Role | What they receive |
|---|---|---|
| ELBW Infants with Prolonged Irradiation Storage Time | Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion had prolonged Irradiation Storage Time (IST) being tested with metabolomics profile. Receives: Device: Near Infrared Spectroscopy | |
| ELBW Infants without Irradiation Storage | Extremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion did not have Irradiation Storage being tested with metabolomics profile. Receives: Device: Near Infrared Spectroscopy | |
| ELBW Infants Reaching the NEC Window | Extremely low birth weight infants who reach 28 to 34 postmenstrual week age, which is the NEC window. Receives: Other: Non-invasive Image-based Anemia Assessment | |
| ELBW Infants | Extremely low birth weight infants having intestinal microbial profiles examined via stool collected from discarded diapers, and immune cell function and serum cytokine levels examined using residual blood. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mesenteric Tissue Oxygenation
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.
Measured: 60 Minutes prior to transfusion to 48 hours after transfusion
Infants Developing TR-NEC
Development of TR-NEC will be compared between infants receiving RBC transfusion with and without IST.
Measured: 60 Minutes prior to transfusion to 48 hours after transfusion
Inhibition of NO-Mediated Vasodilation
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.
Measured: 60 Minutes prior to transfusion to 48 hours after transfusion
Metabolic Changes of Red Blood Cells
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.
Measured: 60 Minutes prior to transfusion to 48 hours after transfusion
Mesenteric Tissue Oxygenation During the NEC Window Period
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).
Measured: 28 to 34 Weeks Post Menstrual Age
Immune Cell Function
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.
Measured: Up to 90 days of age
Microbial Changes
Alterations in the microbiota may further drive dysregulated immune function toward increased overall inflammation and the development of NEC. Microbial profiles will be compared between infants who develop TR-NEC and matched controls who do not.
Measured: Up to 90 days of age
Serum Cytokine Levels
Serum cytokine levels will be compared between infants who develop TR-NEC and matched controls who do not.
Measured: Up to 90 days of age
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startJul 2016
- Primary completion19 Feb 2026
- Study completion19 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnemiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Ravi Mangal Patel, Emory University
- Investigators
- Ravi Patel, MD, MSc, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741648
- Sponsor's protocol ID
- IRB00083691
- Other IDs
- 2P01HL086773, 1R01HL138714, 2025P010798
- Acronym
- RBC-mNIRS
- Status last verified
- Mar 2026
- First submitted
- 13 Apr 2016
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- Individual data sharing
- No
Publications
Marin T, Patel RM, Roback JD, Stowell SR, Guo Y, Easley K, Warnock M, Skvarich J, Josephson CD. Does red blood cell irradiation and/or anemia trigger intestinal injury in premature infants with birth weight </= 1250 g? An observational birth cohort study. BMC Pediatr. 2018 Aug 11;18(1):270. doi: 10.1186/s12887-018-1241-5.
PubMed 30098602
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Red Blood Cell Transfusion and Digestive Tract Oxygenation in Preterm Infants Weighing ≤ 1250 Grams
- ClinicalTrials.gov ID
- NCT02741648
- Acronym / sponsor ID
- RBC-mNIRS / IRB00083691
- Conditions
- Anemia, Necrotizing Enterocolitis
- Keywords
- Red Blood Cell Transfusion, Digestive tract problems, Extremely Low Birth Weight
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- Jul 2016 (actual)
- Primary completion
- 19 Feb 2026 (actual)
- Study completion
- 19 Feb 2026 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Necrotizing Enterocolitis (NEC) is a leading cause of neonatal morbidity and mortality in preterm infants. To date, no effective genetic or clinical markers exist to predict which premature infant will develop NEC, limiting targeted prevention strategies. 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.
Multiple observational studies have reported an association between the exposure to red blood cell (RBC) transfusion and the subsequent development of transfusion related-NEC (TR-NEC).However, no clinical studies have investigated the underlying pathophysiologic mechanisms of TR-NEC. In adults, prolonged RBC storage prior to transfusion has been associated with adverse outcomes and may also contribute to TR-NEC. However, the chronological storage age of blood may not be an accurate gauge of donor RBC function; irradiation of RBCs to prevent transfusion-associated graft-vs-host disease may also contribute to TR-NEC. Currently, the duration considered safe for RBC storage following irradiation (irradiation storage time (IST)) is unclear. Given the multifactorial etiology of NEC, preventative efforts will be more successful if clinicians understand the underlying pathophysiologic mechanisms and modifiable risk factors.
In this study the researchers will conduct a multicenter observational cohort study of very preterm (VPT) infants weighing ≤1250g at birth to prospectively investigate the associations between RBC transfusion, digestive tract oxygenation, and TR-NEC. The overarching hypothesis for this study is that irradiation of RBC units followed by prolonged storage perturbs RBC metabolism and function, and these derangements are associated with paradoxical microvascular vasoconstriction, tissue hypoxia and TR-NEC in transfused infants with already impaired gut oxygenation due to significant anemia. All RBC units transfused to VPT infants throughout the study will be stored based on current standard operating procedures per local site blood banking practices. There will be no study-specific approaches to transfusions or transfusion thresholds, and the decision to transfusion will be made as part of current clinical care by the treating clinicians. No study-specific blood draws will occur and all samples will be obtained from residual samples collected for clinical care that are to be discarded.
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, the researchers intend to better understand intestinal blood flow patterns. RBC function in RBC products transfused to infants will be compared between the infants who develop TR-NEC and matched control infants who do not develop TR-NEC. The researchers will explore the clinical implications of severe anemia when infants are 28 to 34 weeks of postmenstrual age, which is when infants are vulnerable to NEC.
Currently, there are no inexpensive, simple, patient/healthcare provider-operated hemoglobin tests available for diagnosing and assessing the degree of anemia without the use of a blood draw. To that end, Emory investigators have recently developed an algorithm that enables patients/healthcare providers to check if a patient is anemic by simply taking a picture of their fingernail beds on a Smartphone, and running the algorithm on a computer using MATLAB. These studies have shown that the degree of pallor in the fingernail beds, correlates with physiologic levels of hemoglobin in the blood and determines whether or not the patient is anemic. To date, the accuracy of this device has only been tested on adults and older children. Having an accurate and noninvasive means of testing for anemia in VPT infants would reduce the number of blood draws required, decrease the common side effects of phlebotomy, transfusion of RBCs, and would potentially be more cost-effective. As an additional study aim, the researchers of this study seek to develop a new image analysis algorithm (IAA) to predict hemoglobin level and anemia status from fingernail photos. The fingernail beds of VPT infants are extremely small and therefore it is uncertain if the nail bed is the most accurate site to assess anemia in these infants. To determine which site is most accurate in this population pictures will be taken of the fingernail beds, the toe nail beds, the palm of the hand and the sole of the foot with be photographed and analyzed.
Leftover samples of blood, urine, stool, and breast milk will be frozen, and stored and in the event a baby develops a digestive tract complication the samples will be studied in a laboratory to identify markers that indicate a healthy digestive tract versus illness. Immune cell function, digestive tract microbial changes, and serum cytokine levels will be compared between very preterm infants who develop NEC and those who do not.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| ELBW Infants with Prolonged Irradiation Storage Time | – | Device: Near Infrared SpectroscopyExtremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion had prolonged Irradiation Storage Time (IST) being tested with metabolomics profile. |
| ELBW Infants without Irradiation Storage | – | Device: Near Infrared SpectroscopyExtremely Low Birth Weight Infants whose Red Blood Cell (RBC) transfusion did not have Irradiation Storage being tested with metabolomics profile. |
| ELBW Infants Reaching the NEC Window | – | Other: Non-invasive Image-based Anemia AssessmentExtremely low birth weight infants who reach 28 to 34 postmenstrual week age, which is the NEC window. |
| ELBW Infants | – | –Extremely low birth weight infants having intestinal microbial profiles examined via stool collected from discarded diapers, and immune cell function and serum cytokine levels examined using residual blood. |
Who may qualify
- Ages
- 1 day to 5 days
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Extremely low birth weight newborn infants born at Emory University Hospital Midtown, Grady Health System, and Northside Hospital Neonatology. Infants will be followed at Children's Healthcare of Atlanta.
Key inclusion criteria (2 listed)
- Birth weight ≤1250 grams
- Postnatal age within 7 days of birth
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Near Infrared SpectroscopyAlso: NIRSINVOS 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. | Device | ELBW Infants with Prolonged Irradiation Storage Time, ELBW Infants without Irradiation Storage |
| Non-invasive Image-based Anemia AssessmentA trained research associate will take 2 images (one with the camera flash on and one with the camera flash off) of the patient's fingernail beds, toe nail beds, palm of the hand and sole of the foot. Images will be taken within 24 hours, preceding, or following, each complete blood count (CBC) collection on each consented patient. The anemia diagnosing algorithm will then be run on the images. | Other | ELBW Infants Reaching the NEC Window |
Primary outcome
Mesenteric Tissue Oxygenation
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Microbial Changes
Time frame: Up to 90 days of age
Alterations in the microbiota may further drive dysregulated immune function toward increased overall inflammation and the development of NEC. Microbial profiles will be compared between infants who develop TR-NEC and matched controls who do not.
Serum Cytokine Levels
Time frame: Up to 90 days of age
Serum cytokine levels will be compared between infants who develop TR-NEC and matched controls who do not.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Derived from this study: PubMed 30098602Marin T, Patel RM, Roback JD, Stowell SR, Guo Y, Easley K, Warnock M, Skvarich J, Josephson CD. Does red blood cell irradiation and/or anemia trigger intestinal injury in premature infants with birth weight </= 1250 g? An observational birth cohort study. BMC Pediatr. 2018 Aug 11;18(1):270. doi: 10.1186/s12887-018-1241-5.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ravi Patel, MD, MSc principal investigator
Emory University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anemia and Necrotizing Enterocolitis, run by Emory University at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mesenteric Tissue Oxygenation (time frame: 60 Minutes prior to transfusion to 48 hours after transfusion). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02741648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 7 Nov 2026.