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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

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.

Condition or disease
Sepsis Premature Birth

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.

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Study Type : Observational
Actual Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Predictors of Sepsis in Ex-Preterm Infants
Actual Study Start Date : April 18, 2019
Actual Primary Completion Date : January 1, 2022
Actual Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Group/Cohort
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA

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.



Information from the National Library of Medicine

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Ages Eligible for Study:   0 Days to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Both term and preterm infants will be included in the study.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03433846


Locations
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United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Boston Children's Hospital
Investigators
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Principal Investigator: Amy O'Connell, MD Boston Children's Hospital
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Responsible Party: Amy O'Connell, MD, PhD, Boston Children's Hospital
ClinicalTrials.gov Identifier: NCT03433846    
Other Study ID Numbers: IRB-P00023454
First Posted: February 15, 2018    Key Record Dates
Last Update Posted: May 20, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amy O'Connell, Boston Children's Hospital:
Sepsis
Prematurity
Additional relevant MeSH terms:
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Sepsis
Toxemia
Premature Birth
Infections
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications