Neonatal SEPSISNCT03403062
Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis
An observational study of Neonatal SEPSIS, run by Assiut University.
Trial summary
1. Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis . 2. Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis . Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Neonatal SEPSIS
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Feb 2019to Feb 2020
- 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Study population: - Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study. A diagnosis of definite sepsis is made when a pathogenic agent is isolated from the blood or cerebrospinal fluid in the presence of clinical signs suggestive of sepsis. Probable sepsis is diagnosed when positive cultures are lacking in the presence of signs suggestive of sepsis and 2 positive screening parameters (abnormal CRP, erythrocyte sedimentation rate, platelet count, total leucocytic count, absolute neutrophilic count, or immature/total neutrophils ratio >0.2). When signs of sepsis are existent but both sepsis screening parameters and cultures are negative, this is deemed no sepsis
Who may be able to join
- Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study.
Who cannot join
- gestational age less than 37 weeks.
- perinatal asphyxia.
- infants with more than 1 episode of sepsis, only the first one was included.
- Infants with Dysmorphic features suggestive of chromosomal abnormalities.
- neonates under a course of antibiotics prior to appropriate blood sampling.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis in Patients Admitted at Assiut University Children Hospital.
- Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis .
- Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .
Read the detailed description
Sepsis is defined as a life-threatening condition caused by a dysregulated host response to infection. Sepsis is responsible for approximately 45% of neonatal emergencies and is a leading cause of neonatal mortality and morbidity, accounting for 14% of deaths in that age group.
The early symptoms and signs of neonatal sepsis are usually mild and nonspecific but can rapidly progress to septic shock, disseminated intravascular coagulation(DIC), and death. It is therefore of paramount importance to find a tool for prediction of infants who are more likely to experience a worse clinical outcome so that closer monitoring and more aggressive treatment would be offered to them.
Early-onset sepsis (EOS) is usually due to transplacental, ascending, or intrapartum transmission in the perinatal period shortly before or during birth, up to postnatal (PN) 7 days. Late-onset sepsis (LOS) is acquired by horizontal transmission in the home, hospital, or in the community after PN day.
Timely diagnosis and prompt institution of antimicrobial therapy are essential in order to mitigate the high case fatality and to avert morbidity associated with late-onset neonatal sepsis. In the latest years, biochemical markers are important in research areas in neonatal infections. Inflammatory cascade as response to an infection comprise many elevated markers, frequently used for diagnosis and monitoring of sepsis.
Numerous molecules have been studied as potentially useful prognostic markers in neonatal sepsis. These include C-reactive protein (CRP), procalcitonin, IL-6, IL-8, CD64, and soluble E- selectin.
The red cell distribution width (RDW) is a marker, which has been studied in neonatal sepsis. The RDW is a measure of variability of red blood cells in size (anisocytosis) and is routinely evaluated as a part of complete blood count. The RDW may be elevated in conditions of ineffective production, or increased destruction of red blood cells, which commonly occur in inflammatory or infectious situations.
Red cell distribution width has been classically used as a screening index for iron deficiency anemia. However, a growing body of evidence indicates that this simple marker can have a role in predicting adverse outcome in sepsis as well as in diverse clinical situations, including coronary artery disease, heart failure,acute pancreatitis, malignancy, infective endocarditis, peritoneal dialysis, and in critically ill children in general.
The pathophysiology of the elevation of RDW in these patients is not well known, but it has been reported that elevated RDW is associated with inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate, interleukin-6 and tumor necrosis factor-alpha. Proinflammatory cytokines of sepsis have been shown to suppress the maturation of red blood cells (RBC) and decrease the half-life of RBCs, resulting in the elevation of RDW values Most previous studies investigating the prognostic value of RDW were conducted on adult patients, and similar studies in neonatal sepsis are rare and small. The objective of the present research is to investigate the prognostic role of this routinely available marker in full term neonates with sepsis and to compare it with other traditional prognostic biomarkers.
The prognostic potential of RDW is of particular interest because it is routinely included in the automated complete blood count (CBC) analyses in hospitalized patients and thus available and no additional cost for clinicians.
- Conditions
- Neonatal SEPSIS
- Keywords
- Sepsis, red cell distribution width (RDW), Late onset sepsis (LOS), Early onset sepsis (EOS)
- Medical subject headings
- Neonatal Sepsis, Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
the neonatal mortality rate .
Number of neonates died from sepsis .
Measured: 30 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2018
- Study startFeb 2019 (estimated)
- Primary completionJan 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Neonatal SEPSISStudies of the same condition, open and under way.
- More trials run by Assiut 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 only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mariam nagy gamil, Assiut University
- Investigators
- Mariam N Gamil, resident, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03403062
- Sponsor's protocol ID
- RDW and neonatal sepsis
- Status last verified
- Jan 2019
- First submitted
- 13 Dec 2017
- Last updated
- 11 Jan 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338Abiodun MT, Oluwafemi RO. Spectrum and outcome of neonatal emergencies seen in a free health-care program in South-Western Nigeria. Niger J Clin Pract. 2017 Mar;20(3):283-289. doi: 10.4103/1119-3077.187324.
PubMed 28256481Omoigberale AI, Sadoh WE, Nwaneri DU. A 4 year review of neonatal outcome at the University of Benin Teaching Hospital, Benin City. Niger J Clin Pract. 2010 Sep;13(3):321-5.
PubMed 20857794Tran HT, Doyle LW, Lee KJ, Graham SM. A systematic review of the burden of neonatal mortality and morbidity in the ASEAN Region. WHO South East Asia J Public Health. 2012 Jul-Sep;1(3):239-248. doi: 10.4103/2224-3151.207020.
PubMed 28615550Liu B, Chen YX, Yin Q, Zhao YZ, Li CS. Diagnostic value and prognostic evaluation of Presepsin for sepsis in an emergency department. Crit Care. 2013 Oct 20;17(5):R244. doi: 10.1186/cc13070.
PubMed 24138799El Shimi MS, Abou Shady NM, Hamed GM, Shedeed NS. Significance of neutrophilic CD64 as an early marker for detection of neonatal sepsis and prediction of disease outcome. J Matern Fetal Neonatal Med. 2017 Jul;30(14):1709-1714. doi: 10.1080/14767058.2016.1223030. Epub 2016 Aug 31.
PubMed 27578316Zaki Mel-S, el-Sayed H. Evaluation of microbiologic and hematologic parameters and E-selectin as early predictors for outcome of neonatal sepsis. Arch Pathol Lab Med. 2009 Aug;133(8):1291-6. doi: 10.5858/133.8.1291.
PubMed 19653728Boskabadi H, Maamouri G, Tavakol Afshari J, Mafinejad S, Hosseini G, Mostafavi-Toroghi H, Saber H, Ghayour-Mobarhan M, Ferns G. Evaluation of serum interleukins-6, 8 and 10 levels as diagnostic markers of neonatal infection and possibility of mortality. Iran J Basic Med Sci. 2013 Dec;16(12):1232-7.
PubMed 24570828Sadaka F, O'Brien J, Prakash S. Red cell distribution width and outcome in patients with septic shock. J Intensive Care Med. 2013 Sep-Oct;28(5):307-13. doi: 10.1177/0885066612452838. Epub 2012 Jul 17.
PubMed 22809690Jo YH, Kim K, Lee JH, Kang C, Kim T, Park HM, Kang KW, Kim J, Rhee JE. Red cell distribution width is a prognostic factor in severe sepsis and septic shock. Am J Emerg Med. 2013 Mar;31(3):545-8. doi: 10.1016/j.ajem.2012.10.017. Epub 2013 Feb 4.
PubMed 23380094Sipahi T, Koksal T, Tavil B, Akar N. The effects of acute infection on hematological parameters. Pediatr Hematol Oncol. 2004 Sep;21(6):513-20. doi: 10.1080/08880010490477301.
PubMed 15552815Scharte M, Fink MP. Red blood cell physiology in critical illness. Crit Care Med. 2003 Dec;31(12 Suppl):S651-7. doi: 10.1097/01.CCM.0000098036.90796.ED.
PubMed 14724462Acikgoz SK, Acar B, Aydin S, Acikgoz E, Er O, Sensoy B, Balci MM, Yayla C, Sen F, Topal S, Aydogdu S. Red Cell Distribution Width Can Predict the Significance of Angiographically Intermediate Coronary Lesions. Med Princ Pract. 2016;25(1):31-5. doi: 10.1159/000441001. Epub 2015 Oct 16.
PubMed 26468646Felker GM, Allen LA, Pocock SJ, Shaw LK, McMurray JJ, Pfeffer MA, Swedberg K, Wang D, Yusuf S, Michelson EL, Granger CB; CHARM Investigators. Red cell distribution width as a novel prognostic marker in heart failure: data from the CHARM Program and the Duke Databank. J Am Coll Cardiol. 2007 Jul 3;50(1):40-7. doi: 10.1016/j.jacc.2007.02.067. Epub 2007 Jun 18.
PubMed 17601544Li Y, Zhao Y, Feng L, Guo R. Comparison of the prognostic values of inflammation markers in patients with acute pancreatitis: a retrospective cohort study. BMJ Open. 2017 Mar 27;7(3):e013206. doi: 10.1136/bmjopen-2016-013206.
PubMed 28348184
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Red Cell Distribution Width (RDW) in Neonatal Sepsis in Patients Admitted at Assiut University Children Hospital.
- ClinicalTrials.gov ID
- NCT03403062
- Acronym / sponsor ID
- RDW and neonatal sepsis
- Conditions
- Neonatal SEPSIS
- Keywords
- Sepsis, red cell distribution width (RDW), Late onset sepsis (LOS), Early onset sepsis (EOS)
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Feb 2019 (estimated)
- Primary completion
- Jan 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 18 Jan 2018 (actual)
- 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.
- Evaluate the relationship of RDW and severity and mortality in patients with neonatal sepsis .
- Using RDW as a simple, inexpensive, applicable and rapid test to detect prognosis of neonatal sepsis .
Detailed description
Sepsis is defined as a life-threatening condition caused by a dysregulated host response to infection. Sepsis is responsible for approximately 45% of neonatal emergencies and is a leading cause of neonatal mortality and morbidity, accounting for 14% of deaths in that age group.
The early symptoms and signs of neonatal sepsis are usually mild and nonspecific but can rapidly progress to septic shock, disseminated intravascular coagulation(DIC), and death. It is therefore of paramount importance to find a tool for prediction of infants who are more likely to experience a worse clinical outcome so that closer monitoring and more aggressive treatment would be offered to them.
Early-onset sepsis (EOS) is usually due to transplacental, ascending, or intrapartum transmission in the perinatal period shortly before or during birth, up to postnatal (PN) 7 days. Late-onset sepsis (LOS) is acquired by horizontal transmission in the home, hospital, or in the community after PN day.
Timely diagnosis and prompt institution of antimicrobial therapy are essential in order to mitigate the high case fatality and to avert morbidity associated with late-onset neonatal sepsis. In the latest years, biochemical markers are important in research areas in neonatal infections. Inflammatory cascade as response to an infection comprise many elevated markers, frequently used for diagnosis and monitoring of sepsis.
Numerous molecules have been studied as potentially useful prognostic markers in neonatal sepsis. These include C-reactive protein (CRP), procalcitonin, IL-6, IL-8, CD64, and soluble E- selectin.
The red cell distribution width (RDW) is a marker, which has been studied in neonatal sepsis. The RDW is a measure of variability of red blood cells in size (anisocytosis) and is routinely evaluated as a part of complete blood count. The RDW may be elevated in conditions of ineffective production, or increased destruction of red blood cells, which commonly occur in inflammatory or infectious situations.
Red cell distribution width has been classically used as a screening index for iron deficiency anemia. However, a growing body of evidence indicates that this simple marker can have a role in predicting adverse outcome in sepsis as well as in diverse clinical situations, including coronary artery disease, heart failure,acute pancreatitis, malignancy, infective endocarditis, peritoneal dialysis, and in critically ill children in general.
The pathophysiology of the elevation of RDW in these patients is not well known, but it has been reported that elevated RDW is associated with inflammatory markers such as C-reactive protein (CRP), erythrocyte sedimentation rate, interleukin-6 and tumor necrosis factor-alpha. Proinflammatory cytokines of sepsis have been shown to suppress the maturation of red blood cells (RBC) and decrease the half-life of RBCs, resulting in the elevation of RDW values Most previous studies investigating the prognostic value of RDW were conducted on adult patients, and similar studies in neonatal sepsis are rare and small. The objective of the present research is to investigate the prognostic role of this routinely available marker in full term neonates with sepsis and to compare it with other traditional prognostic biomarkers.
The prognostic potential of RDW is of particular interest because it is routinely included in the automated complete blood count (CBC) analyses in hospitalized patients and thus available and no additional cost for clinicians.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- - Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study. A diagnosis of definite sepsis is made when a pathogenic agent is isolated from the blood or cerebrospinal fluid in the presence of clinical signs suggestive of sepsis. Probable sepsis is diagnosed when positive cultures are lacking in the presence of signs suggestive of sepsis and 2 positive screening parameters (abnormal CRP, erythrocyte sedimentation rate, platelet count, total leucocytic count, absolute neutrophilic count, or immature/total neutrophils ratio >0.2). When signs of sepsis are existent but both sepsis screening parameters and cultures are negative, this is deemed no sepsis
Key inclusion criteria (1 listed)
- Any infant from birth to 1 month of age with a diagnosis of definite or probable sepsis will included in the study.
Key exclusion criteria (5 listed)
- gestational age less than 37 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the neonatal mortality rate .
Time frame: 30 day
Number of neonates died from sepsis .
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2019.
- Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
- Background: PubMed 28256481Abiodun MT, Oluwafemi RO. Spectrum and outcome of neonatal emergencies seen in a free health-care program in South-Western Nigeria. Niger J Clin Pract. 2017 Mar;20(3):283-289. doi: 10.4103/1119-3077.187324.
- Background: PubMed 20857794Omoigberale AI, Sadoh WE, Nwaneri DU. A 4 year review of neonatal outcome at the University of Benin Teaching Hospital, Benin City. Niger J Clin Pract. 2010 Sep;13(3):321-5.
- Background: PubMed 28615550Tran HT, Doyle LW, Lee KJ, Graham SM. A systematic review of the burden of neonatal mortality and morbidity in the ASEAN Region. WHO South East Asia J Public Health. 2012 Jul-Sep;1(3):239-248. doi: 10.4103/2224-3151.207020.
- Background: PubMed 24138799Liu B, Chen YX, Yin Q, Zhao YZ, Li CS. Diagnostic value and prognostic evaluation of Presepsin for sepsis in an emergency department. Crit Care. 2013 Oct 20;17(5):R244. doi: 10.1186/cc13070.
- Background: PubMed 27578316El Shimi MS, Abou Shady NM, Hamed GM, Shedeed NS. Significance of neutrophilic CD64 as an early marker for detection of neonatal sepsis and prediction of disease outcome. J Matern Fetal Neonatal Med. 2017 Jul;30(14):1709-1714. doi: 10.1080/14767058.2016.1223030. Epub 2016 Aug 31.
- Background: PubMed 19653728Zaki Mel-S, el-Sayed H. Evaluation of microbiologic and hematologic parameters and E-selectin as early predictors for outcome of neonatal sepsis. Arch Pathol Lab Med. 2009 Aug;133(8):1291-6. doi: 10.5858/133.8.1291.
- Background: PubMed 24570828Boskabadi H, Maamouri G, Tavakol Afshari J, Mafinejad S, Hosseini G, Mostafavi-Toroghi H, Saber H, Ghayour-Mobarhan M, Ferns G. Evaluation of serum interleukins-6, 8 and 10 levels as diagnostic markers of neonatal infection and possibility of mortality. Iran J Basic Med Sci. 2013 Dec;16(12):1232-7.
- Background: PubMed 22809690Sadaka F, O'Brien J, Prakash S. Red cell distribution width and outcome in patients with septic shock. J Intensive Care Med. 2013 Sep-Oct;28(5):307-13. doi: 10.1177/0885066612452838. Epub 2012 Jul 17.
- Background: PubMed 23380094Jo YH, Kim K, Lee JH, Kang C, Kim T, Park HM, Kang KW, Kim J, Rhee JE. Red cell distribution width is a prognostic factor in severe sepsis and septic shock. Am J Emerg Med. 2013 Mar;31(3):545-8. doi: 10.1016/j.ajem.2012.10.017. Epub 2013 Feb 4.
- Background: PubMed 15552815Sipahi T, Koksal T, Tavil B, Akar N. The effects of acute infection on hematological parameters. Pediatr Hematol Oncol. 2004 Sep;21(6):513-20. doi: 10.1080/08880010490477301.
- Background: PubMed 14724462Scharte M, Fink MP. Red blood cell physiology in critical illness. Crit Care Med. 2003 Dec;31(12 Suppl):S651-7. doi: 10.1097/01.CCM.0000098036.90796.ED.
- Individual participant dataSharing planned: Undecided
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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.
Mariam N Gamil, resident principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Neonatal SEPSIS, run by Assiut University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 11 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariam N Gamil, Resident (00201285508913, mnga_15@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the neonatal mortality rate . (time frame: 30 day). 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 NCT03403062, which also lists 21 linked publications.
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 11 Jan 2019.