Complication of PrematurityNCT02554630
Novel Mechanisms and Approaches to Treat Neonatal Sepsis
An observational study of Complication of Prematurity and Immunologic Deficiency Syndromes, run by University of Florida at 1 site in United States.
Trial summary
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700 million in the US alone. Read more about this study
- Who is it for?
- Ages Up to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Complication of Prematurity, Immunologic Deficiency Syndromes
- What is being tested?
- Adjuvant and Blood Collection
- How many people
- 142 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2016to 21 Oct 2022
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Preterm neonates 0-72 hours old Term Neonates 0-72 hours old Healthy Adult Controls 18-55 years old
Who may be able to join
- Consent to participate in the study
- Consent to participate in the study
- Age >18 years old, <55 years old
Who cannot join
- non- survivable condition
- Healthy Adult Controls
- Age <18 years old, >55 years old
- Severe pre-existing organ dysfunction
- Oncolytic therapy within 14 days
- HIV positive status
- Current use of chronic steroids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Mechanisms and Approaches to Treat Neonatal Sepsis: Adjuvant Therapies, Host Microbiome, and Genomic Expression and Functional Capacity of Innate Immune Cells
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700 million in the US alone.
In an effort to help mature the neonatal immune system, several adjuvant therapies have been studied; however, none have been implemented in clinical practice. One of the most frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a viable approach to reducing the incidence of early and late sepsis.
This research study will characterize immune genomic expression and functional capacity at the time of birth in both term and preterm neonates and determine what effects, if any, that adjuvants have on this function. Additionally, this study will seek to determine if immune function correlates with certain microbiota.
Read the detailed description
Blood samples will be collected from three populations: preterm infants, term infants and healthy adult controls. In addition, a collection of meconium (<1mL) from the diaper of these term and preterm neonates;
- Term neonates (gestational age 37-42 weeks) between birth and 72 hours of life who have blood collected for the following clinical indications:
- Blood will be collected at 0-72 hours of life from neonates that are undergoing state metabolic screens or for clinical evaluation jaundice. The sample will be obtained during the standard of care state metabolic screen or for clinical evaluation of jaundice. The neonate will only have an extra drop of blood placed (500-700 micro-liters) in a tube during the heel sticks. Neonates will only have 1 sample drawn throughout the duration of the study.
- Preterm neonates (gestational age 24-37 weeks) consisting of two populations between birth and 72 hours of life who have blood collected for the following clinical indications:
- Blood will be collected at 0-72 hours of life from neonates that are otherwise healthy and do not require additional laboratory testing who are undergoing state metabolic screens or for evaluation of jaundice. The neonate will only have an extra drop of blood placed (500-700 microliters) in a tube during the heel stick. Neonates will only have 1 sample drawn throughout the duration of the study.
- A second group of premature neonates will have blood drawn for complications related to prematurity (sepsis work-up). The neonate will only have an extra drop of blood placed (500-700 micro-liters) in a tube during one of these clinical blood draws.
- Healthy adult controls will have (4milleters) blood collected by way of vein puncture.
For all infants, term and preterm, the following data will be collected at the time of blood collection: gender, gestational age, weight, mechanism of birth (vaginal vs cesarean section), evidence of infectious complication (chorioamnionitis, prolonged rupture of membranes, maternal group B strep colonization, hypoglycemia), use of perinatal antibiotics or steroids, laboratory values available in the electronic medial record (CBC, CMP, Lactic acid, CRP) and Apgar scores will be collected from each patient. Additionally the clinical outcomes of these patients, term and preterm,will be collected until time of discharge but not to exceed 90 days.
- Being tested
- Adjuvant, Blood Collection
- Medical subject headings
- Immunologic Deficiency Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdjuvantOther
Also called Lippopolysaccaride, Specific toll-like receptor 4 agonist, Non-specific toll-like receptor 4 agonist
Blood will be incubated, ex-vivo, with one of the adjuvant therapies or no adjuvant and then, using microfluidic techniques the immune genomic profile and the functional capacity of immune cells will be assessed.
Blood CollectionOther
Blood collection will be performed on all groups.
| Study group | Role | What they receive |
|---|---|---|
| Preterm Neonate | Neonates of gestational age 24-37 weeks. Blood collection will be performed at the time of a clinically required heelstick or blood draw. Microfluidic techniques, utilizing whole blood, will be employed to characterize the baseline genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. Meconium will be collected for microbiome analysis. Clinical outcomes will be recorded from the electronic medical record. Receives: Other: Adjuvant; Other: Blood Collection | |
| Term Neonates | Neonates of gestational age 37-42 weeks. Blood collection will be performed at the time of a clinically required heelstick or blood draw. Microfluidic techniques, utilizing whole blood, will be employed to characterize the baseline genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. Meconium will be collected for microbiome analysis. Clinical outcomes will be recorded from the electronic medical record. Receives: Other: Adjuvant; Other: Blood Collection | |
| Healthy Adult Control | Healthy Adult aged 18-55 years will undergo a single blood collection by the way of vein puncture. Microfluidic techniques, utilizing whole blood, will be employed to evaluate the genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. Receives: Other: Adjuvant; Other: Blood Collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genomic analysis
The genomic profile will be interpreted using Ingenuity Pathway Analysis (IPA) software to make functional predictions. Additionally, a cytokine analysis, and an evaluation for the prevalence of myeloid derived suppressor cells (MDSCs) that have been shown to correlate with poorer outcomes in adult sepsis studies will be performed.
Measured: Day 1
Functional immunologic analysis
Functional capacity will be confirmed directly by observing chemotaxis and quantifying generation of reactive oxygen species (ROS), rate of phagocytosis, and bacterial killing ability. Additionally, a cytokine analysis, and an evaluation for the prevalence of myeloid derived suppressor cells (MDSCs) that have been shown to correlate with poorer outcomes in adult sepsis studies will be performed.
Measured: Day 1
Secondary outcomes (4)
Immune Function Correlation with Clinical Outcomes
The clinical course of these neonates will be followed for incidence of infectious complications including sepsis as evident by culture results. Therefore, allowing the investigators to determine if immunologic deficits present at birth correlate with clinical outcomes.
Measured: 90 days
Ex-vivo Adjuvant Therapies On Immune Function
The implementation of adjuvants in both murine and human models has shown improved function of immune effector cells as well as in clinical outcomes. Adjuvant treatment of mice with TLR agonists stimulates polymorphonuclear leukocytes (PMN) recruitment and function, decreases rates of bacteremia, and increases survival to polymicrobial and gram negative sepsis. Vaccination with Bacillus Calmette-Guerin (BCG) at birth reduces mortality by 40% in LBW infants to sepsis (not tuberculosis) in sub-Saharan Africa. Utilizing an ex-vivo design we will evaluate the changes in immune cell functional capacity.
Measured: Day 1
Ex-vivo Adjuvant Therapies Effect On Immune Cell Genomic Expression
The implementation of adjuvants in both murine and human models has shown improved function of immune effector cells as well as in clinical outcomes. Adjuvant treatment of mice with TLR agonists stimulates polymorphonuclear leukocytes (PMN) recruitment and function, decreases rates of bacteremia, and increases survival to polymicrobial and gram negative sepsis. Vaccination with Bacillus Calmette-Guerin (BCG) at birth reduces mortality by 40% in LBW infants to sepsis (not tuberculosis) in sub-Saharan Africa. Utilizing an ex-vivo design we will evaluate the changes in immune cell genomic expression.
Measured: Day 1
Microbiome Influences Immune Cell Function
Correlated immune deficiencies with differences in the microbiome at the time of birth will be documented by using microbiomic differences present at the time of birth in term vs preterm neonates using Illumina 16s rRNA technology. This system uses highly conserved sequences among bacteria to identify and classify bacterium. The software then provides taxonomic classification to find a microbiomic signature that is specific to immune dysfunction.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2015 (estimated)
- Study startFeb 2016
- Primary completion21 Oct 2022
- Study completion21 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Complication of PrematurityStudies of the same condition, open and under way.
- More trials run by University of FloridaThe 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
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Surgical Infection Society
- Responsible party
- Sponsor
- Investigators
- Shawn Larson, MD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02554630
- Sponsor's protocol ID
- IRB201500447 -N
- Other IDs
- R01GM097531
- Status last verified
- Feb 2023
- First submitted
- 17 Sep 2015
- Last updated
- 10 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Watson RS, Carcillo JA, Linde-Zwirble WT, Clermont G, Lidicker J, Angus DC. The epidemiology of severe sepsis in children in the United States. Am J Respir Crit Care Med. 2003 Mar 1;167(5):695-701. doi: 10.1164/rccm.200207-682OC. Epub 2002 Nov 14.
PubMed 12433670Lawn JE, Kerber K, Enweronu-Laryea C, Cousens S. 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol. 2010 Dec;34(6):371-86. doi: 10.1053/j.semperi.2010.09.011.
PubMed 21094412Cuenca AG, Wynn JL, Moldawer LL, Levy O. Role of innate immunity in neonatal infection. Am J Perinatol. 2013 Feb;30(2):105-12. doi: 10.1055/s-0032-1333412. Epub 2013 Jan 7.
PubMed 23297181PrabhuDas M, Adkins B, Gans H, King C, Levy O, Ramilo O, Siegrist CA. Challenges in infant immunity: implications for responses to infection and vaccines. Nat Immunol. 2011 Mar;12(3):189-94. doi: 10.1038/ni0311-189. No abstract available.
PubMed 21321588Wynn JL, Scumpia PO, Winfield RD, Delano MJ, Kelly-Scumpia K, Barker T, Ungaro R, Levy O, Moldawer LL. Defective innate immunity predisposes murine neonates to poor sepsis outcome but is reversed by TLR agonists. Blood. 2008 Sep 1;112(5):1750-8. doi: 10.1182/blood-2008-01-130500. Epub 2008 Jun 30.
PubMed 18591384Wynn JL, Levy O. Role of innate host defenses in susceptibility to early-onset neonatal sepsis. Clin Perinatol. 2010 Jun;37(2):307-37. doi: 10.1016/j.clp.2010.04.001.
PubMed 20569810Yost CC, Cody MJ, Harris ES, Thornton NL, McInturff AM, Martinez ML, Chandler NB, Rodesch CK, Albertine KH, Petti CA, Weyrich AS, Zimmerman GA. Impaired neutrophil extracellular trap (NET) formation: a novel innate immune deficiency of human neonates. Blood. 2009 Jun 18;113(25):6419-27. doi: 10.1182/blood-2008-07-171629. Epub 2009 Feb 12.
PubMed 19221037Gessler P, Nebe T, Birle A, Haas N, Kachel W. Neutrophil respiratory burst in term and preterm neonates without signs of infection and in those with increased levels of C-reactive protein. Pediatr Res. 1996 May;39(5):843-8. doi: 10.1203/00006450-199605000-00017.
PubMed 8726239Gentile LF, Nacionales DC, Lopez MC, Vanzant E, Cuenca A, Cuenca AG, Ungaro R, Szpila BE, Larson S, Joseph A, Moore FA, Leeuwenburgh C, Baker HV, Moldawer LL, Efron PA. Protective immunity and defects in the neonatal and elderly immune response to sepsis. J Immunol. 2014 Apr 1;192(7):3156-65. doi: 10.4049/jimmunol.1301726. Epub 2014 Mar 3.
PubMed 24591376Cuenca AG, Cuenca AL, Gentile LF, Efron PA, Islam S, Moldawer LL, Kays DW, Larson SD. Delayed emergency myelopoiesis following polymicrobial sepsis in neonates. Innate Immun. 2015 May;21(4):386-91. doi: 10.1177/1753425914542445. Epub 2014 Aug 7.
PubMed 25106654Sweeney SE, Firestein GS. Primer: signal transduction in rheumatic disease--a clinician's guide. Nat Clin Pract Rheumatol. 2007 Nov;3(11):651-60. doi: 10.1038/ncprheum0631.
PubMed 17968336Kollmann TR, Crabtree J, Rein-Weston A, Blimkie D, Thommai F, Wang XY, Lavoie PM, Furlong J, Fortuno ES 3rd, Hajjar AM, Hawkins NR, Self SG, Wilson CB. Neonatal innate TLR-mediated responses are distinct from those of adults. J Immunol. 2009 Dec 1;183(11):7150-60. doi: 10.4049/jimmunol.0901481. Epub 2009 Nov 16.
PubMed 19917677
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Mechanisms and Approaches to Treat Neonatal Sepsis: Adjuvant Therapies, Host Microbiome, and Genomic Expression and Functional Capacity of Innate Immune Cells
- ClinicalTrials.gov ID
- NCT02554630
- Acronym / sponsor ID
- IRB201500447 -N
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- National Institute of General Medical Sciences (NIGMS), Surgical Infection Society
- Study start
- Feb 2016
- Primary completion
- 21 Oct 2022 (actual)
- Study completion
- 21 Oct 2022 (actual)
- First posted
- 18 Sep 2015 (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.
Mortality related to neonatal sepsis exceeds 1 million deaths worldwide; the highest risk of mortality is in preterm neonates, especially low birth weight (LBW), and very low birth weight (VLBW) neonates. The estimated cost of caring for these patients is approximately $700 million in the US alone.
In an effort to help mature the neonatal immune system, several adjuvant therapies have been studied; however, none have been implemented in clinical practice. One of the most frequently considered targets for adjuvant therapy is toll-like receptors (TLRs). TLRs detect conserved molecular products of microorganisms (lipopolysaccharide (LPS), and initiate immunity and inflammation. Early adjuvant administration in VLBW infants may be a viable approach to reducing the incidence of early and late sepsis.
This research study will characterize immune genomic expression and functional capacity at the time of birth in both term and preterm neonates and determine what effects, if any, that adjuvants have on this function. Additionally, this study will seek to determine if immune function correlates with certain microbiota.
Detailed description
Blood samples will be collected from three populations: preterm infants, term infants and healthy adult controls. In addition, a collection of meconium (<1mL) from the diaper of these term and preterm neonates;
- Term neonates (gestational age 37-42 weeks) between birth and 72 hours of life who have blood collected for the following clinical indications:
- Blood will be collected at 0-72 hours of life from neonates that are undergoing state metabolic screens or for clinical evaluation jaundice. The sample will be obtained during the standard of care state metabolic screen or for clinical evaluation of jaundice. The neonate will only have an extra drop of blood placed (500-700 micro-liters) in a tube during the heel sticks. Neonates will only have 1 sample drawn throughout the duration of the study.
- Preterm neonates (gestational age 24-37 weeks) consisting of two populations between birth and 72 hours of life who have blood collected for the following clinical indications:
- Blood will be collected at 0-72 hours of life from neonates that are otherwise healthy and do not require additional laboratory testing who are undergoing state metabolic screens or for evaluation of jaundice. The neonate will only have an extra drop of blood placed (500-700 microliters) in a tube during the heel stick. Neonates will only have 1 sample drawn throughout the duration of the study.
- A second group of premature neonates will have blood drawn for complications related to prematurity (sepsis work-up). The neonate will only have an extra drop of blood placed (500-700 micro-liters) in a tube during one of these clinical blood draws.
- Healthy adult controls will have (4milleters) blood collected by way of vein puncture.
For all infants, term and preterm, the following data will be collected at the time of blood collection: gender, gestational age, weight, mechanism of birth (vaginal vs cesarean section), evidence of infectious complication (chorioamnionitis, prolonged rupture of membranes, maternal group B strep colonization, hypoglycemia), use of perinatal antibiotics or steroids, laboratory values available in the electronic medial record (CBC, CMP, Lactic acid, CRP) and Apgar scores will be collected from each patient. Additionally the clinical outcomes of these patients, term and preterm,will be collected until time of discharge but not to exceed 90 days.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Preterm Neonate | – | Other: Adjuvant, Other: Blood CollectionNeonates of gestational age 24-37 weeks. Blood collection will be performed at the time of a clinically required heelstick or blood draw. Microfluidic techniques, utilizing whole blood, will be employed to characterize the baseline genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. Meconium will be collected for microbiome analysis. Clinical outcomes will be recorded from the electronic medical record. |
| Term Neonates | – | Other: Adjuvant, Other: Blood CollectionNeonates of gestational age 37-42 weeks. Blood collection will be performed at the time of a clinically required heelstick or blood draw. Microfluidic techniques, utilizing whole blood, will be employed to characterize the baseline genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. Meconium will be collected for microbiome analysis. Clinical outcomes will be recorded from the electronic medical record. |
| Healthy Adult Control | – | Other: Adjuvant, Other: Blood CollectionHealthy Adult aged 18-55 years will undergo a single blood collection by the way of vein puncture. Microfluidic techniques, utilizing whole blood, will be employed to evaluate the genomic profile and functional capacity of immune cells. Adjuvant drugs will be employed ex-vivo to determine if adjuvant therapies change genomic expression and bolster immune function. |
Who may qualify
- Ages
- Up to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Preterm neonates 0-72 hours old Term Neonates 0-72 hours old Healthy Adult Controls 18-55 years old
Key inclusion criteria (3 listed)
- Consent to participate in the study
- Consent to participate in the study
- Age >18 years old, <55 years old
Key exclusion criteria (7 listed)
- non- survivable condition
- Healthy Adult Controls
- Age <18 years old, >55 years old
- Severe pre-existing organ dysfunction
- Oncolytic therapy within 14 days
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 |
|---|---|---|
| AdjuvantAlso: Lippopolysaccaride, Specific toll-like receptor 4 agonist, Non-specific toll-like receptor 4 agonistBlood will be incubated, ex-vivo, with one of the adjuvant therapies or no adjuvant and then, using microfluidic techniques the immune genomic profile and the functional capacity of immune cells will be assessed. | Other | Healthy Adult Control, Preterm Neonate, Term Neonates |
| Blood CollectionBlood collection will be performed on all groups. | Other | Healthy Adult Control, Preterm Neonate, Term Neonates |
Primary outcome
Genomic analysis
Time frame: Day 1
The genomic profile will be interpreted using Ingenuity Pathway Analysis (IPA) software to make functional predictions. Additionally, a cytokine analysis, and an evaluation for the prevalence of myeloid derived suppressor cells (MDSCs) that have been shown to correlate with poorer outcomes in adult sepsis studies will be performed.
Functional immunologic analysis
Time frame: Day 1
Functional capacity will be confirmed directly by observing chemotaxis and quantifying generation of reactive oxygen species (ROS), rate of phagocytosis, and bacterial killing ability. Additionally, a cytokine analysis, and an evaluation for the prevalence of myeloid derived suppressor cells (MDSCs) that have been shown to correlate with poorer outcomes in adult sepsis studies will be performed.
4 secondary outcomes
Immune Function Correlation with Clinical Outcomes
Time frame: 90 days
Ex-vivo Adjuvant Therapies On Immune Function
Time frame: Day 1
Ex-vivo Adjuvant Therapies Effect On Immune Cell Genomic Expression
Time frame: Day 1
Microbiome Influences Immune Cell Function
Time frame: Day 1
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 10 Feb 2023.
- Background: PubMed 12433670Watson RS, Carcillo JA, Linde-Zwirble WT, Clermont G, Lidicker J, Angus DC. The epidemiology of severe sepsis in children in the United States. Am J Respir Crit Care Med. 2003 Mar 1;167(5):695-701. doi: 10.1164/rccm.200207-682OC. Epub 2002 Nov 14.
- Background: PubMed 21094412Lawn JE, Kerber K, Enweronu-Laryea C, Cousens S. 3.6 million neonatal deaths--what is progressing and what is not? Semin Perinatol. 2010 Dec;34(6):371-86. doi: 10.1053/j.semperi.2010.09.011.
- Background: PubMed 23297181Cuenca AG, Wynn JL, Moldawer LL, Levy O. Role of innate immunity in neonatal infection. Am J Perinatol. 2013 Feb;30(2):105-12. doi: 10.1055/s-0032-1333412. Epub 2013 Jan 7.
- Background: PubMed 21321588PrabhuDas M, Adkins B, Gans H, King C, Levy O, Ramilo O, Siegrist CA. Challenges in infant immunity: implications for responses to infection and vaccines. Nat Immunol. 2011 Mar;12(3):189-94. doi: 10.1038/ni0311-189. No abstract available.
- Background: PubMed 18591384Wynn JL, Scumpia PO, Winfield RD, Delano MJ, Kelly-Scumpia K, Barker T, Ungaro R, Levy O, Moldawer LL. Defective innate immunity predisposes murine neonates to poor sepsis outcome but is reversed by TLR agonists. Blood. 2008 Sep 1;112(5):1750-8. doi: 10.1182/blood-2008-01-130500. Epub 2008 Jun 30.
- Background: PubMed 20569810Wynn JL, Levy O. Role of innate host defenses in susceptibility to early-onset neonatal sepsis. Clin Perinatol. 2010 Jun;37(2):307-37. doi: 10.1016/j.clp.2010.04.001.
- Background: PubMed 19221037Yost CC, Cody MJ, Harris ES, Thornton NL, McInturff AM, Martinez ML, Chandler NB, Rodesch CK, Albertine KH, Petti CA, Weyrich AS, Zimmerman GA. Impaired neutrophil extracellular trap (NET) formation: a novel innate immune deficiency of human neonates. Blood. 2009 Jun 18;113(25):6419-27. doi: 10.1182/blood-2008-07-171629. Epub 2009 Feb 12.
- Background: PubMed 8726239Gessler P, Nebe T, Birle A, Haas N, Kachel W. Neutrophil respiratory burst in term and preterm neonates without signs of infection and in those with increased levels of C-reactive protein. Pediatr Res. 1996 May;39(5):843-8. doi: 10.1203/00006450-199605000-00017.
- Background: PubMed 24591376Gentile LF, Nacionales DC, Lopez MC, Vanzant E, Cuenca A, Cuenca AG, Ungaro R, Szpila BE, Larson S, Joseph A, Moore FA, Leeuwenburgh C, Baker HV, Moldawer LL, Efron PA. Protective immunity and defects in the neonatal and elderly immune response to sepsis. J Immunol. 2014 Apr 1;192(7):3156-65. doi: 10.4049/jimmunol.1301726. Epub 2014 Mar 3.
- Background: PubMed 25106654Cuenca AG, Cuenca AL, Gentile LF, Efron PA, Islam S, Moldawer LL, Kays DW, Larson SD. Delayed emergency myelopoiesis following polymicrobial sepsis in neonates. Innate Immun. 2015 May;21(4):386-91. doi: 10.1177/1753425914542445. Epub 2014 Aug 7.
- Background: PubMed 17968336Sweeney SE, Firestein GS. Primer: signal transduction in rheumatic disease--a clinician's guide. Nat Clin Pract Rheumatol. 2007 Nov;3(11):651-60. doi: 10.1038/ncprheum0631.
- Background: PubMed 19917677Kollmann TR, Crabtree J, Rein-Weston A, Blimkie D, Thommai F, Wang XY, Lavoie PM, Furlong J, Fortuno ES 3rd, Hajjar AM, Hawkins NR, Self SG, Wilson CB. Neonatal innate TLR-mediated responses are distinct from those of adults. J Immunol. 2009 Dec 1;183(11):7150-60. doi: 10.4049/jimmunol.0901481. Epub 2009 Nov 16.
- 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.
Shawn Larson, MD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Complication of Prematurity and Immunologic Deficiency Syndromes, run by University of Florida at 1 site 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 3 inclusion and 7 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 10 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Genomic analysis (time frame: Day 1). The study lists 2 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 NCT02554630, which also lists 12 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 10 Feb 2023.