Characteristics of Cord Blood Immunologic Parameters of Infants <32 Weeks Gestation

Sepsis Clinical Trial

— AOS  

Official title:

Characteristics of Cord Blood Immunologic Parameters of Infants < 32 Weeks Gestation

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00524394
• Other study ID #: HSC-MS-07-0021
• Status: Terminated
• Phase: N/A
• First received: August 30, 2007
• Last updated: November 5, 2015
• Start date: August 2007
• Est. completion date: January 2012

Study information

• Verified date: November 2015
• Source: The University of Texas Health Science Center, Houston
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Infants in the NICU are at high risk for morbidity and mortality from infections of any onset. Diagnosis of these infections is imperfect at best. Patterns of inflammatory and regulatory proteins (cytokines & chemokines, in addition to antigen detection on antibody secreting cells (ASC's)may provide a more accurate and rapid approach to diagnosis of infections in these high-risk patients.

Description:

Sampling methods/Data collection

Samples: Serum (1-2ml) from enrolled infants will be collected from cord blood (T0). Serial samples (0.5-1ml) will be collected at 3 other times: T1= 4-7 days, T2=10-14 days, T3= 20-30 days. These can be drawn at initiation of any sepsis work-up, or prior to any transfusion of PRBC's or when any blood ≥0.5ml will be wasted. These collections are intended to analyze the immunologic milieu in infants at various stages of natal and post-natal immune adaptation:

1. baseline levels from a relatively privileged environment (cord blood T0)

2. peak of immunogenic response after prenatal exposure (T1)

3. plateau of immunogenic response after perinatal exposure (T2)

4. relative state of equilibrium with surrounding flora (T3)

Data collection:

Baseline statistics at enrollment: Birth weight, obstetrical assessment of gestational age, mode of delivery, presence of labor, presence of IAI, ROM, intrapartum antibiotics type and length, With each sampling, data will be gathered via chart review on each infant. We will also gather data at 60 DOL, discharge, or death on any infant enrolled.

Measurements:

Experimental laboratory:

Cytokines- Each sample will have plasma analyzed by Luminex (Biorad) to determine profiles of cytokines: IL-2, IL-6, IL-8, IL-13, MIP1b, MCP1, IL-1b, IL-4, IL-5, IL-7, IL-10, IL-12p70, IL-17, GMCSF, IFN-gamma, and TNF-alpha. Standard curves for each cytokine measurement were run to determine upper and lower limits of detection.

ASC- will be quantified by enzyme-linked immunospot assay (ELISPOT) for specific isotypes IgA, IgM, and IgG. They will also be linked to 3 particular immunogenic agents: GBS, Candida, and CoNS.

Clinical laboratory:

Total WBC and band ratio will be run in the routine course of care for these infants. This is not an additional sample.

serious bacterial infections other than sepsis (meningitis, UTI)

• Course of Study- 0-30 days of life for sampling. 0-60 days of life for data collection.

• Enrollment- consecutive admissions of NICU under the following criteria

Inclusion:

Admitted to NICU at MHCH

• 1500gm or ≤ 32 wk GA Birth to <31 days of life at time of enrollment

Exclusion:

Known or suspected immunodeficiency (including maternal HIV or other known congenital infection) Known major congenital anomaly

• Recruitment Will include each eligible infant by the primary investigator or co-investigators. Assuming an incidence of LOS of ~25% and EOS of ~1-3%, a power of 80%, we should enroll 50 infants. This coincides with prior studies evaluating ASC's response in neonates, and those evaluating cytokines in cord blood and post-natally.

• Known Risks There will be no additional blood draws. There will be collection of a greater volume of blood (additional 0.5ml-1.0ml depending on size of infant) during clinical indications for blood draws. No clinical decisions will be made based on the data obtained.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 3 Days

Eligibility

Inclusion Criteria:

• Infants born at Children's Memorial Hermann Hospital with cord blood available < 1500gm or < 32 weeks gestation by OB estimate

Exclusion Criteria:

• Outborn infants transferred to CMHH without cord blood available

• Parents to not consent

• > 1500gm or > 32 weeks gestation by OB estimate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Premature Birth
• Sepsis

Locations

Country	Name	City	State
United States	Children's Memorial Hermann Hospital	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Immunological Homeostasis	Describe changes in immunological homeostasis that indicate the "normal" function vs. presence of sepsis in newborn infants of various gestational ages	0 to 30 days of life.	No
Primary	Cytokines	IL2 IL6 IL8 IL13 MIP1B MCP1 IL1B IL4 IL5 IL7 IL10 IL12P70 Measure of Cytokines presence and level .	O TO 30 DAYS OF LIFE	No