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Predictors of Sepsis in Ex-Preterm Infants

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ClinicalTrials.gov Identifier: NCT03433846
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : May 20, 2022
Sponsor:
Information provided by (Responsible Party):
Amy O'Connell, Boston Children's Hospital

Tracking Information
First Submitted Date February 3, 2018
First Posted Date February 15, 2018
Last Update Posted Date May 20, 2022
Actual Study Start Date April 18, 2019
Actual Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 15, 2021)
The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term. [ Time Frame: Up to 1 year ]
The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.
Original Primary Outcome Measures
 (submitted: February 8, 2018)
The presence or absence of skewed or altered immune profile in preterm infants compared to infants born at term. [ Time Frame: Up to 1 year ]
The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers. Stool samples will be deep sequenced to determine the genera of microbes present in the fecal sample.
Change History
Current Secondary Outcome Measures
 (submitted: March 15, 2021)
Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization. [ Time Frame: Up to 1 year ]
The investigators will measure nutritional status. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers.
Original Secondary Outcome Measures
 (submitted: February 8, 2018)
Determining whether non-modifiable variables of nutrition status, microbiome composition, or immune repertoire composition predict risk of developing infection during the hospitalization. [ Time Frame: Up to 1 year ]
The investigators will measure nutritional status and obtain stool samples to analyze the composition of the microbiome. Whole blood samples will be separated into serum and cellular components and sera will be used to assess cytokine predominance and measure nutritional markers. Stool samples will be deep sequenced to determine the genera of microbes present in the fecal sample.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Predictors of Sepsis in Ex-Preterm Infants
Official Title Predictors of Sepsis in Ex-Preterm Infants
Brief Summary

The aims of this study are to:

  • Assess whether ex-preterm infants have a persistently immature immune system, which may decrease their ability to respond to infections, when they reach term-corrected gestational age.
  • Examine whether clinical history, nutrition status, and microbiome composition are linked to the immune composition of term and ex-preterm infants and whether these variables can be used to predict the risk of developing sepsis or having an immunologic disease.
Detailed Description

Preterm infants have increased numbers of viral infections in childhood. They are also more likely to die from infection during the neonatal and infant periods than infants born at term. While studies have demonstrated that premature infants have decreased adaptive and innate immune responses compared with infants born at term, there has been little investigation into whether this impaired immunity improves and becomes similar to full term infants once the ex-preterm infants reach term-corrected gestational age. There have likewise not been studies to determine whether specific immune markers may predict the risk of developing sepsis. Given the immaturity of the preterm immune system and the many potential infectious and inflammatory insults they are exposed to during the preterm period (infections, poor nutrition, stress, steroid therapy), there is also a possibility that the relative immune deficiency experienced by preterm infants may persist into infancy.

The goal of this study is to determine whether former preterm infants have sustained differences in immunity compared to age-matched controls, which would have significant implications for infection risk and response to vaccination. Additionally, this study hopes to examine whether certain immune system abnormalities make certain babies more likely to have a serious infection. The present study will assess composition and function of T and B cell compartments in preterm and former preterm infants.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

Subjects will have up to 0.5 ml of blood collected as a sample within the first 1-2 weeks after the subject is enrolled. After that any discard blood samples which have been obtained as part of clinically requested blood draws will be obtained from the Core Laboratory at the institution.

If there are no discard samples available an additional 0.5mL blood sample and a stool sample will be collected on a monthly basis until the subject is discharged from the hospital or up to a maximum of 6 months.

If the investigators learn information that might be important for the subject's family the investigators may be able to have these results confirmed by a CLIA-certified clinical laboratory that is allowed to provide results.

Sampling Method Non-Probability Sample
Study Population Both term and preterm infants will be included in the study.
Condition
  • Sepsis
  • Premature Birth
Intervention Not Provided
Study Groups/Cohorts
  • Preterm Infants
    Blood samples will be obtained from preterm and former preterm infants at birth and then monthly until hospital discharge. The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen. If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
  • Term Infants
    Blood samples will be obtained from term control infants admitted to the NICU monthly until hospital discharge. The sample would consist of either up to 0.5ml of blood obtained during a requested clinical blood draw, discarded blood, or a dried blood spot specimen. If no discard samples are available and study blood samples need to be obtained instead, this will occur for a maximum period of 6 months and no more than 3ml of blood will be collected over the entire study period.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 18, 2022)
40
Original Estimated Enrollment
 (submitted: February 8, 2018)
46
Actual Study Completion Date May 1, 2022
Actual Primary Completion Date January 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria Ex-Preterm Infant Group:

  • Infants born less than 37 weeks gestational age

Exclusion Criteria for Ex-Preterm Infant Group:

  • Infants born greater than 37 weeks gestational age

Inclusion Criteria for Term Infant Group:

  • Infants born greater than 37 weeks gestational age

Exclusion Criteria for Term Infant Group:

  • Infants born less than 37 weeks gestational age
Sex/Gender
Sexes Eligible for Study: All
Ages 0 Days to 2 Years   (Child)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03433846
Other Study ID Numbers IRB-P00023454
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Amy O'Connell, Boston Children's Hospital
Original Responsible Party Same as current
Current Study Sponsor Boston Children's Hospital
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators
Principal Investigator: Amy O'Connell, MD Boston Children's Hospital
PRS Account Boston Children's Hospital
Verification Date May 2022