Novel Mechanisms and Approaches to Treat Neonatal Sepsis
| Status: | Recruiting |
|---|---|
| Conditions: | Infectious Disease, HIV / AIDS |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any - 55 |
| Updated: | 10/12/2018 |
| Start Date: | February 2016 |
| End Date: | January 2020 |
| Contact: | Joy Perkins, RN |
| Email: | joy.perkins@surgery.ufl.edu |
| Phone: | 352-294-5687 |
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.
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.
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;
1. Term neonates (gestational age 37-42 weeks) between birth and 72 hours of life who have
blood collected for the following clinical indications:
a. 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.
2. 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:
1. 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.
2. 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.
3. 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.
healthy adult controls. In addition, a collection of meconium (<1mL) from the diaper of these
term and preterm neonates;
1. Term neonates (gestational age 37-42 weeks) between birth and 72 hours of life who have
blood collected for the following clinical indications:
a. 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.
2. 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:
1. 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.
2. 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.
3. 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.
Preterm and Term neonates 0-72 hours old
Inclusion Criteria:
- Consent to participate in the study
Exclusion Criteria:
- non- survivable condition
Healthy Adult Controls
Inclusion Criteria:
- Consent to participate in the study
- Age >18 years old, <55 years old
Exclusion Criteria:
- 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
We found this trial at
1
site
Click here to add this to my saved trials
